(LOS ANGELES) -- Two couples have filed lawsuits against in vitro fertilization provider Ovation Fertility alleging its clinic destroyed their embryos when a lab employee wrongly used hydrogen peroxide instead of a sterile solution in an incubator.
The couples allege that the clinic still used the embryos despite knowing they were nonviable. Neither woman got pregnant.
In two nearly identical lawsuits filed on Thursday against Ovation Fertility in Newport Beach, California, two unnamed couples are asserting multiple claims, including negligent misrepresentation, fraud, negligence and medical battery. The couples are not revealing their names in the lawsuits to protect their privacy, according to the suits.
In two nearly identical lawsuits filed on Thursday, two unnamed couples are accusing Ovation Fertility in Newport Beach, California, of negligent misrepresentation fraud, negligence and medical battery. The couples are not revealing their names in the lawsuits to protect their privacy, according to the suits.
Embryos belonging to likely dozens of patients were destroyed by hydrogen peroxide in the latter half of January 2024, the couples' attorney, Adam Wolf, said in a press conference Thursday.
The clinic did not realize there was a problem with the embryos until they saw low success rates for implantation in January and investigated why, Wolf told ABC News. Wolf said Ovation Fertility then reached out to at least some of the impacted patients.
Ovation Fertility did not immediately respond to ABC News' request for comment regarding the suits.
The couples allege they may not be able to have children who are biologically related to them -- since they say they have no more viable embryos -- because of Ovation Fertility's actions.
In the suits, the couples claim the hydrogen peroxide killed their embryos before they were transferred and that there was no chance they would become pregnant.
The suits, filed in California Superior Court, seek jury trials and are asking for an unspecified amount of damages.
The couples allege that the clinic put an extremely unsafe amount of hydrogen peroxide in an incubator used to store the embryos and failed to have the proper procedures and protocols in place to ensure the toxic incubator would not harm their embryos despite the clinic's claims to the contrary.
"Hydrogen peroxide is something that can be in the lab of a fertility clinic; there is nothing wrong with that," Wolf said. "What was entirely wrong about this was the levels and concentration of hydrogen peroxide that was used in this incubator apparently having mixed up hydrogen peroxide and a sterile solution," Wolf said at the press conference.
"This was an error that had massive implications for likely dozens of patients," Wolf said. "This killed their embryos. In certain states, those are human beings."
They also allege that the clinic did not properly train their employees on how to operate, manage or maintain the embryo incubator.
The couples also allege they were told their embryos were viable and had not been harmed at the time of the transfer, despite allegedly knowing that this was not true.
One couple said they only had one genetically normal embryo and it was destroyed in the incubator.
The other couple said they underwent two separate egg retrievals and had two high-quality embryos that were destroyed in the toxic incubator.
(NEW YORK) -- Heat-related emergency room visits increased in 2023 in the U.S. compared to previous years, according to new federal data.
Between Jan. 1, 2023 and Dec. 31, 2023, there were a total of 119,605 ER visits for heat-related illnesses, with 92% of those visits occurring between May and September, according to a report published Thursday by the Centers for Disease Control and Prevention.
July and August had higher than average ER visits due to heat than other warm-season months, including May, June and September, according to the report, which looked at data of ER visits caused by heat in 2023 and compared it t visits between 2018 and 2022. These findings are "consistent with record-breaking temperatures observed … in 2023." said the CDC.
The risk of heat-related ER visits during July and August 2023 was more than three times that seen in May, June, and September.
By comparison, the risk during July and August from 2018 to 2022 was about twice as high as in May, June and September of the same period.
The study also found some regions of the U.S. -- as defined by the Department of Health and Human Services -- saw higher risk in 2023 than others. The states of Arkansas, Louisiana, New Mexico, Oklahoma and Texas were most impacted with reported risk of nine times the risk of New York and New Jersey.
These regions also saw their daily ER visits for heat-related illness rates in 2023 exceed the 95th percentile reported between 2018 and 2022.
Every U.S. region saw at least one day in 2023 above the 95th percentile. In the southwestern and western U.S, heat-related ER visit rates in July 2023 exceeded the 2018 to 2022 95th percentile for 16 and 18 consecutive days, respectively.
Additionally, the southwestern and lower Midwestern U.S. experienced days with the highest rate of heat-related ER visits recorded for the respective region since 2018.
When broken down by sex and age, the report found more men than women sought care in ERs for heat-related illnesses in 2023 at a rate of 271 per 100,000 ER visits for males compared to 104 per 100,000 visits for females.
Adults between ages 18 and 64 also had higher rates in 2023 with a range of 207 to 222 per 100,000 visits compared to the range of 120 to 173 per 100,000 visits for adults aged 65 and older.
This data aligns with how extreme heat events in the U.S., and around the globe, are becoming more frequent and more intense. Summer 2023 was Earth's hottest since global records began in 1880, according to NASA.
Several cities across the U.S. saw record-breaking triple-digit temperatures in summer 2023. El Paso, Texas, saw a record stretch of 44 consecutive days at or over 100 F in June and July, and Phoenix, Arizona saw a record of 31 days at 110 F or higher.
Additionally, Americans could see an average of 53 more days of extreme heat by 2050 if greenhouse gas emissions aren't reduced, according to climate modeling data from the the ICF Climate Center.
"Deaths and illnesses associated with heat exposure are a continuing public health concern as climate change results in longer, hotter, and more frequent episodes of extreme heat," the authors of the report wrote. "Near real-time monitoring of weather conditions and adverse health outcomes can guide public health practitioners' timing of risk communication and implementation of prevention measures associated with extreme heat."
ABC News' Julia Jacobo contributed to this report.
(NEW YORK) -- Racial and ethnic disparities in health care are evident in every state, even those with robust health systems, according to a new analysis from the Commonwealth Fund.
In the analysis from the organization, which is aimed at promoting equitable health care, researchers found health system performance is markedly worse for many people of color compared to white people.
"Even among high performing states, we see significant disparities," Joseph Betancourt, M.D., president of the Commonwealth Fund, said in a report on the organization’s updated findings.
Six states were found to have better-than-average health system performance among all racial or ethnic groups, including Rhode Island, Massachusetts, Connecticut, Hawaii, New Hampshire and New York. However, even among these high-scoring health systems, racial disparities were observed.
"This report demonstrates that if you don't look under the hood, you won't identify where you're failing people and where you're leaving people behind," Betancourt said.
Particularly when looking at health outcomes, large disparities in premature deaths from avoidable causes are apparent in all states. Black, and American Indian and Alaska Native (AIAN) people are more likely to die before age 75 from preventable and treatable causes, including, but not limited to, some infections such as appendicitis and certain cancers, than white populations, according to the analysis.
There are also large disparities in health care access between white people and other racial or ethnic groups across all states. Despite coverage expansion by the Affordable Care Act in recent years, states' uninsured rates are generally higher and more variable for Black, Hispanic, and AIAN adults compared to Asian American, Native Hawaiian, and Pacific Islander (AANHPI) and white adults, according to the analysis. In particular, Hispanic people had the highest uninsured rates and cost-related difficulties in accessing care in almost all states.
"These groups have more problems accessing care and if quality of care is lower, then they have worse health outcomes compared to white people in many states," Senior Scientist David Radley, Ph.D., of the Commonwealth Fund, said in the report.
The analysis, which was done using publicly available databases reporting outcomes from more than 328,000,000 people during the years 2021 and 2022, concluded that achieving health equity requires policy action and health system action, including:
Ensuring affordable, comprehensive, and equitable health insurance coverage for all
Strengthening primary care
Improving health care quality and delivery
Health systems and providers prioritizing and centering equity
Investing in social services
Improving the collection and analysis of racial and ethnic data to identify gaps
Developing equity-focused measures to inform and evaluate policy
"Some of the major takeaways of this work is that we still have a lot of work to do," Senior Scholar and Commonwealth Fund Vice President Sara R. Collins said in the organization’s report. "Maybe in a decade we'll look at this data and we'll see some of these gaps closing.”
Dr. Laurie Zephyrin, a senior vice president for the Commonwealth Fund, said undertaking the prescribed action will likely help.
"The reality is we can't improve healthcare if we're not accurately measuring and tracking these outcomes and experiences and using real data as a guidepost to ensure that we are advancing towards equity. ... All these comprehensive actions are truly a start. It really can help us move forward to advance health equity and address many of the inequities that we talked about today," she said in the report.
The Commonwealth Fund’s State Scorecard on Health System Performance series evaluated each state’s health care system and is a tool developed to understand health inequities and disparities. It uses 25 data indicators to designate a "State Health Equity Score," which indicates each state health system’s performance based on health care access, quality, service use and health outcome. Scores were also determined for each of five racial or ethnic groups (Black, AIAN, AANHPI and Latinx/Hispanic) during the years 2021 and 2022, notably incorporating post-pandemic effects on health disparities.
(NEW YORK) -- Nobel Prize-winning molecular biologist Venki Ramakrishnan sat down with ABC News Live to discuss the science and ethics of extending the human lifespan.
In his new book, "Why We Die: The New Science of Aging and the Quest for Immortality," Ramakrishnan explains why we may not want to lengthen our lives much longer.
Ramakrishnan's thought-provoking argument is that a society where people lived for hundreds of years could potentially become stagnant, as it would consist of the same group of people living longer, raising important questions about societal dynamics and progress.
He discussed the cycle of life and why we die.
ABC NEWS LIVE: If you think it might be wonderful to live forever, you may want to hear what a Nobel Prize-winning molecular biologist has to say that could change your mind. Venki Ramakrishnan has examined the latest science, weighed the possibilities and researched the ethical cause of lengthening our lifespans in his new book, 'Why We Die The New Science of Aging and the Quest for Immortality.' Doctor, thank you so much for joining us.
RAMAKRISHNAN: Thank you.
ABC NEWS LIVE: So humans now live twice as long as we did 150 years ago. But you raise some, some caveats to why we may not want to lengthen our lives that much longer. Why is that?
RAMAKRISHNAN: Well, I think a society where everybody lived indefinitely or very long time, say, hundreds of years would be a very different society. It would be quite stagnant. It'd be the same group of people just living longer and longer.
You wouldn't have that turnover between generations. You know, maybe new ideas, things like that. But I think that's still in the realm of science fiction. I think biology is looking at the causes of aging, and that's allowing us to tackle some of these causes. But most of the focus is how to live healthily for longer, because all developed societies are living longer lives.
So we're having more and more older people well past retirement. And we want to see how can we keep older people healthy and productive, you know, and energetic and and actually lively. So I think a lot of biology is trying to understand those causes so we don't suffer some of the debilitating consequences of aging.
ABC NEWS LIVE: Explain why it is that sometimes our biological age doesn't match our chronological age.
RAMAKRISHNAN: That's because aging you can think of as an accumulation of damage as over time. And we have very sophisticated repair mechanisms, and we have ways to deal with the problems of old age, of the accumulation of damage, accumulation of garbage in the cells. We have recycling mechanisms and all those things break down. And the rate at which they break down is different for different people.
ABC NEWS LIVE: Explain the new research, though, that talks about how there are certain blood markers that indicate why people age faster than others, and we could say this is separate from drinking and smoking or lack of sleep.
RAMAKRISHNAN: Yeah. So blood -- there are different markers for aging. So some markers are on our DNA. Our DNA acquires marks called epigenetic marks as we age. And that changes the pattern with which we express different genes.
So it changes how our biology works. There are also markers in our blood. And this was found because when they connected an old animal with a young animal and allowed them to exchange their blood supply, the old animal benefited from the young blood. And that suggested these things in younger blood that deteriorate or don't exist or have changed in older blood. And people are trying to find what those markers are.
ABC NEWS LIVE: Let's say in the next few decades, we're able to come up with cure for, for cancer, high blood pressure, diabetes. What's the best-case scenario, do you think, for the longevity of human life?
RAMAKRISHNAN: So someone did a calculation. And if we eliminated some of the major causes of fatality today, like the things you mentioned, you would only gain about 15 years. But what biologists think is if you tackle the underlying causes of aging, then you could really, expect to, live a longer and healthier life.
ABC NEWS LIVE: Really fascinating. Doctor, we thank you so much for joining us. Want to let our viewers know "Why We die? The New Science of Aging and the Quest for Immortality" is now available wherever books are sold.
(NEW YORK) -- The New York Department of Health and Mental Hygiene has released a health advisory after multiple cases of human leptospirosis -- an infection that is associated to exposure to rat urine -- have been reported so far this year in New York City.
There were 24 cases of leptospirosis in the city in 2023, higher than in any prior year, according to the NYC Department of Health and Mental Hygiene.
However, in the first quarter of this year alone, there have already been six to date.
“For comparison, the average number of locally acquired cases during 2021 to 2023 was 15 per year, and 3 cases per year during 2001 to 2020,” health officials said. “This year, 6 cases have been reported as of April 10, 2024.”
“Among the 98 locally acquired cases reported from 2001 to 2023, the median case age was 50 years (range 20 to 80 years), usually male (94%) and, reported most often from the Bronx (37), followed by Brooklyn (19), Manhattan (28), Queens (10), and Staten Island (4),” said the NYC Department of Health and Mental Hygiene.
Those suffering from severe leptospirosis have acute renal and hepatic failure and, occasionally, severe pulmonary issues, health officials in New York City said. However, symptoms may include fever, headache, chills, muscle aches, vomiting, diarrhea, cough, conjunctival suffusion, jaundice, and rash, the city said.
The incubation period is usually five to 14 days but it is possible for it to last between two to 30 days. If leptospirosis is not treated, kidney failure, meningitis, liver damage, and respiratory distress can occur.
There were a total of six deaths caused by leptospirosis from 2001 to 2023 in New York City, according to the NYC Department of Health and Mental Hygiene.
“In NYC, locally acquired cases typically have a history of a residential or occupational exposure to rat urine or environments (including soil and water) and materials contaminated with rat urine (e.g., handling trash bags or bins containing food waste)," health officials said in their press release regarding the uptick in cases of leptospirosis. “Person-to-person transmission is rare. The NYC Health Department conducts inspections and works with property owners to remediate rat conditions, if indicated.”
According to the NYC Department of Health and Mental Hygiene, leptospira bacteria are fragile and can die within minutes in dry heat or freezing temperatures.
“The cold winters of NYC likely limit the extent to which leptospires can survive in the environment,” health officials said. “However excessive rain and unseasonably warm temperatures, factors associated with climate change, may support the persistence of leptospires in more temperate areas like NYC.”
In 2023, half of the locally acquired cases were reported in the months of June (five) and October (five), months that were warmer and wetter with excessive rain and unseasonably warm days compared to prior years, according to the NYC Department of Health and Mental Hygiene.
Cases of leptospirosis must be reported to the NYC Health Department within 24 hours and more information about the illness can be found on the New York City Health Department and CDC websites.
“As always, we appreciate your collaboration in improving the health of New Yorkers and helping us direct remediation efforts in New York City,” said Celia Quinn, Deputy Commissioner of the Division of Disease Control in New York City.
(NEW YORK) -- A trade association is calling on melatonin makers to follow new guidelines on labeling and packaging for their products amid a rise in emergency room visits and calls to poison centers for accidental ingestion of melatonin by children.
The new guidelines, announced Monday by the Council for Responsible Nutrition, which represents the dietary supplement and functional food industry, call for melatonin-containing products to be sold in child-deterrent packaging and to caution consumers on the label that the products are for intermittent use only, may cause drowsiness and should not be taken with alcohol.
The guidelines also focus specifically on melatonin products that are sold in the shape of gummies, which can be more appealing to kids.
The guidelines call for melatonin-containing gummy products to also be packaged in child-deterrent packaging, and in packaging with clear warnings on the label that the gummies are to be used "under appropriate conditions and guidance."
Labels on melatonin-containing gummy products intended for children under 4 years old should also contain a warning that they could "present a potential choking hazard," the group said.
Melatonin is a hormone that plays a role in sleep, according to the National Institutes of Health.
In the United States, melatonin supplements are considered dietary supplements, which means they are accessible to the public without the regulations of a prescription drug.
The new guidelines issued by the CRN are voluntary, meaning it will be up to the manufacturers of melatonin products to decide if they are put into effect.
In March, the U.S. Centers for Disease Control and Prevention released new data showing that between 2019 and 2022, there were approximately 11,000 emergency room visits involving children aged 5 years and under who ingested melatonin unsupervised.
The data followed previous findings from the CDC that over the past decade, the number of children overdosing on melatonin has increased by 530%.
In 2021 alone, more than 50,000 calls were placed to poison control centers in the United States regarding melatonin ingestion by kids, the CDC found.
According to the study's authors, "increased sales, availability, and widespread [melatonin] use have likely resulted in increased access and exposure risk among children in the home."
Because melatonin is a hormone, there is a possibility that taking it by supplement for several years could impact a child's hormonal development like puberty and menstruation, according to the NIH. However, studies have produced inconsistent results and more studies involving children are needed to understand the extent of effects on development.
Even in adults, according to the NIH, the long-term impacts of melatonin are not well-known, even if the supplement does appear to be mostly safe with short-term use.
The American Academy of Pediatrics recommends any use of melatonin by kids be directed by a pediatrician.
When a child ingests melatonin without adult supervision, it is a medical emergency that requires immediate action, such as calling 911 or calling a poison control center at 800-222-1222.
Symptoms of melatonin ingestion in kids includes abdominal pain, nausea or vomiting, excessive tiredness and labored breathing.
ABC News chief medical correspondent Dr. Jennifer Ashton, a board-certified OB-GYN and obesity medicine physician, said parents should not only keep medications out of sight and reach of children, including teenagers, but also should have conversations with their kids about medication safety.
"You always want to use any medication exposure as an opportunity to really teach that child about medication, that it should only be given by an adult, is not candy and can have consequences both good and bad," Ashton said previously on ABC's Good Morning America.
The CDC also has additional tips here for keeping medication safely away from kids.
(NEW YORK) -- The Centers for Disease Control and Prevention -- alongside the U.S. Food and Drug Administration and local and state health departments -- is continuing to investigate after 19 people across nine states have experienced harmful reactions after being given botulinum toxin injections.
The injections were either counterfeit or administered by unlicensed or untrained individuals and/or in non-health care settings, including homes or spas, according to the CDC.
On Tuesday, the FDA issued an alert to health care professionals and consumers that "unsafe counterfeit versions of Botox" were found in multiple states, warning that bogus or mishandled Botox products can lead to serious complications.
What is Botox?
Botulinum toxin is a neurotoxic protein made from a toxin produced by the bacterium Clostridium botulinum.
It blocks chemical signals from the nerves that cause muscles to contract. The muscles temporarily relax, reducing the appearance of wrinkles. Botox is the most common brand name of the injection.
Botox is most often used on the face to reduce forehead lines, frown lines and crow's feet but can also be used for people with excessive underarm sweating, muscle disorders such as cerebral palsy, neck spasms, overactive bladder, migraines and other conditions.
Why can Botox injections be dangerous?
Forms of purified botulinum toxin are approved by the FDA for certain medical and cosmetic treatments, according to the Mayo Clinic.
They are considered safe when administered by licensed health care providers who meet medical control standards as dictated by the FDA.
However, when Botox is not correctly prepared, stored or administered, it can lead to a rare but serious illness called botulism, which is when the toxin attacks the body's nerves. This can cause muscle paralysis, difficulty breathing and even death.
Botulism is treated with an antitoxin, which prevents the toxin from causing any more harm, according to the CDC. Fewer than five of every 100 people with botulism die, the agency says.
But even with antitoxins and medical care, people may suffer from fatigue or shortness of breath for years after the infection has cleared.
What to know about the latest series of illnesses?
So far, 19 people across nine states -- including Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee and Washington -- have reported harmful reactions, according to the CDC.
The patients -- all of them female -- received the injections from unlicensed or untrained individuals or in non-health care settings.
The patients' ages ranged from 25 to 59 years and the overwhelming majority, 95%, reported receiving injections for cosmetic purposes.
Patients said they experienced a variety of symptoms including blurry vision, double vision, drooping eyelids, dry mouth, difficulty sweating, slurred speech, fatigue, weakness sand difficulty breathing.
Nine were hospitalized and four were treated with botulism antitoxin because of concerns the botulinum toxin could have spread beyond the injection site.
According to the CDC, five patients were tested for botulism. The results were negative.
If you are considering botulinum toxin injections
If you are considering getting Botox, the CDC recommends asking the provider if they are licensed and trained to administer the injection. Some states have tools that allow patients to look up if the provider or setting has the appropriate license.
Additionally, patients should ask if the product has been approved by the FDA and if it has been obtained from a reliable source.
If there is any doubt about the provider, the setting or the product, the CDC advises against the injection.
"Botox injections are a medical procedure and should only be performed in a medical office by board-certified dermatologists or an appropriately trained non-physician clinician, under the direct on-site supervision of a board-certified dermatologist," according to a statement from the American Academy of Dermatology.
If you receive the injection and are experiencing any symptoms of botulism, the CDC says to see your health care provider or to go to the emergency room immediately.
How to tell if a Botox product is counterfeit
AbbVie and Allergan -- which is part of AbbVie -- are the only approved Botox manufacturers and there is currently no evidence the harmful reactions are linked to the genuine product, according to the FDA.
There are some signs that a version may be counterfeit, including the outer carton and vial containing lot number C3709C3 as well as the outer carton displaying the active ingredient as "Botulinum Toxin Type A" instead of "OnabotulinumtoxinA."
If the outer carton and vial indicates 150-unit doses, this is counterfeit because it is not a unit made by AbbVie or Allergan. Genuine products come in 50-, 100- and 200-unit doses.
Additionally, outer cartons that contain a language that is not English are counterfeit.
People who suspect counterfeit Botox products are encouraged to file a report with the FDA.
(TOPEKA, Ks.) -- Kansas Gov. Laura Kelly, a Democrat, vetoed a ban on gender-affirming medical care for transgender youth in the state.
"This divisive legislation targets a small group of Kansans by placing government mandates on them and dictating to parents how to best raise and care for their children," said Kelly in a veto message on Friday. "I do not believe that is a conservative value, and it's certainly not a Kansas value."
She vetoed a similar bill almost one year ago, saying, "Companies have made it clear that they are not interested in doing business with states that discriminate against workers and their families."
She continued, "By stripping away rights from Kansans and opening the state up to expensive and unnecessary lawsuits, these bills would hurt our ability to continue breaking economic records and landing new business deals."
State GOP legislators may be able to override Kelly's veto.
The legislature would need a two-thirds vote to override the veto -- 84 in the House and 27 in the Senate. The Republican-backed bill has enough votes in the Senate to override the veto. In the House, two House Republicans who were previously registered as absent would need to also vote in favor of the bill to override the governor's veto.
This bill restricts puberty blockers, which trans minors may use to delay the development of gendered characteristics. Puberty blockers are reversible and widely used on children who experience puberty earlier than what is typical.
The bill also restricts hormone therapy, which older minors may use for desired changes to certain gendered characteristics that are less reversible, including their body, hair or voice. The bill also restricts surgeries, which physicians say are rare for minors and only done in severe cases.
However, the bill allows exceptions for these procedures on minors who are intersex, have ambiguous sex characteristics, or have disorders of sex development.
Health care providers who violate these provisions could be subject to civil action and have their license revoked if the bill is passed.
The bill also restricts state employees or state facilities from supporting a minor's social transitioning -- including a change in pronouns or name, how they are dressed, and more.
Supporters of gender-affirming care bans say gender-affirming care is harmful for minors. Some argue trans youth should wait until they're older to access gender-affirming care.
Kansas Senate President Ty Masterson, a Republican, applauded the legislation's passage through the legislature.
"The Senate took a firm stand in support of helping and not harming children by making it clear that radical transgender ideology and the mutilation of minors is not legal nor welcome in Kansas," Masterson said.
Critics of the gender-affirming care ban called the bill "more extreme and misinformed than similar bills in other parts of the country."
"In addition to depriving parents and families of medical freedom, this bill actually punishes teachers, doctors, nurses, and more for just doing their jobs by respecting and supporting Kansas kids, including transgender kids," said the ACLU of Kansas in a statement asking Kelly to veto the bill.
Transgender youth, often because of gender-related discrimination and gender dysphoria, are more likely to experience anxiety, depressed mood, and suicidal ideation and attempts, according to the Centers for Disease Control and Prevention.
A recent study in the New England Journal of Medicine found that hormone therapy can improve the mental health of transgender adolescents and teenagers.
Restrictions on access to gender-affirming care for transgender youth have been passed in at least 23 states, some of which have faced legal challenges that argue such bans violate the rights of the youth, their families and their medical providers. Gender-affirming care bans have been blocked in court in Arkansas, Idaho, Florida and Montana, but have been allowed in others.
According to the ACLU, more than 480 anti-LGBTQ bills have been introduced across the the U.S. At least 135 of those bills are no longer progressing through state legislatures, according to the ACLU.
(NEW YORK) -- Drug shortages have reached an all-time high in the United States, pharmacists are warning.
During the first three months of 2024, there were 323 active medication shortages, according to the American Society of Health-System Pharmacists (ASHP) and Utah Drug Information Service. Previously, the record high was 320 shortages in 2014.
This ASHP started tracking shortages in 2001.
"All drug classes are vulnerable to shortage," Dr. Paul Abramowitz, CEO of ASHP, said in a statement. "Some of the most worrying shortages involve generic sterile injectable medications, including cancer chemotherapy drugs and emergency medications stored in hospital crash carts and procedural areas."
Last year, the American Cancer Society issued a warning that chemotherapy drugs had returned to the list of the top-five drug classes affected by shortages and warned this could have a devastating effect on patients.
Some hospitals and clinics reported being completely out of the medications. Doctors have been forced to either ration cancer drugs or triage which patients receive the drugs first.
Additionally, Abramowitz said there are ongoing national shortages for Attention-Deficit/Hyperactivity Disorder (ADHD) medications, which remain "an issue for clinicians and patients."
Among them is the ADHD prescription drug Adderall. The shortage began in late 2022 initially due to a delay from a manufacturer. As of early 2024, the shortage is now demand-driven, according to the U.S. Food and Drug Administration.
"The FDA can utilize different tools during a shortage to assist manufactures with increasing supply including expediting review of a supplement to add additional supply of active ingredients or adding additional capacity," an FDA official told ABC News in a statement earlier this year. "Unfortunately, we are not able to share specific actions, as they are considered commercial confidential information. "
Shortages of some drugs have been an ongoing problem in the U.S. for more than a decade and were recently exacerbated by the COVID-19 pandemic, according to a report by the Senate Homeland Security Committee in March 2023. Lack of necessary medication means patients have to get delayed treatments, substitutions or sometimes no treatment at all, the report found.
At a hearing of the House Ways and Means Committee earlier this year, expert witnesses -- practitioners, researchers and pharmaceutical company executives -- said drug shortages can hurt patients financially because they may turn to alternate products that can cost more.
ASHP said it is working with the federal government to advise HHS agencies on their response to shortages and on steps the trade group believes the federal government could take to alleviate the shortage, including Congress requiring manufacturers to be more transparent about any supply chain issues and to encourage greater diversity in the supply chain.
ASHP, however, said it had concerns about a proposal from the U.S. Department of Health & Human Services that would issue financial penalties for hospitals that lack the resources to stockpile medications.
"Much work remains to be done at the federal level to fix the root causes of drug shortages," Abramowitz said. "ASHP will continue to engage with policymakers regularly as we guide efforts to draft and pass new legislation to address drug shortages and continue to strongly advocate on behalf of our members for solutions that work."
ABC News' Kristina Abovyan and Youri Benadjaoud contributed to this report.
(LONDON) -- A new report commissioned by the National Health Service England advocates for further research on gender-affirming care for transgender youth and young adults.
Dr. Hillary Cass, a former president of the Royal College of Paediatrics and Child Health, was appointed by NHS England and NHS Improvement to chair the Independent Review of Gender Identity Services in 2020 amid a rise in referrals to NHS' gender services. Upon review, she advises "extreme caution" for the use of hormone therapies.
"It is absolutely right that children and young people, who may be dealing with a complex range of issues around their gender identity, get the best possible support and expertise throughout their care," Cass states in the report.
Around 2022, about 5,000 adolescents and children were referred to the NHS' gender services. The report estimated that roughly 20% of children and young people seen by the Gender Identity Development Service (GIDS) enter a hormone pathway -- roughly 1,000 people under 18 in England.
Following four years of data analysis, Cass concluded that "while a considerable amount of research has been published in this field, systematic evidence reviews demonstrated the poor quality of the published studies, meaning there is not a reliable evidence base upon which to make clinical decisions, or for children and their families to make informed choices."
Cass continued: "The strengths and weaknesses of the evidence base on the care of children and young people are often misrepresented and overstated, both in scientific publications and social debate," read the report.
Among her recommendations, she urged the NHS to increase the available workforce in this field, to work on setting up more regional outlets for care, increase investment in research on this care, and improve the quality of care to meet international guidelines.
Cass' review comes as the NHS continues to expand its children and young people's gender identity services across the country. The NHS has recently opened new children and young people's gender services based in London and the Northwest.
NHS England, the country's universal healthcare system, said the report is expected to guide and shape its use of gender affirming care in children and potentially impact youth patients in England accessing gender-affirming care.
The debate over transgender youth care In an interview with The Guardian, Cass stated that her findings are not intended to undermine the validity of trans identities or challenge young people's right to transition but to improve the care they are receiving.
"We've let them down because the research isn't good enough and we haven't got good data," Cass told the news outlet. "The toxicity of the debate is perpetuated by adults, and that itself is unfair to the children who are caught in the middle of it. The children are being used as a football and this is a group that we should be showing more compassion to."
In the report, Cass argued that the knowledge and expertise of "experienced clinicians who have reached different conclusions about the best approach to care" has been "dismissed and invalidated" amid arguments concerning transgender care in youth.
Cass did not immediately respond to ABC News' request for comment.
Recommendations for trans youth care Cass is calling for more thorough research that looks at the "characteristics, interventions and outcomes" of NHS gender service patients concerning puberty blockers and hormone therapy, particularly among children and adolescents.
The report's recommendations also urge caregivers to take an approach to care that considers young patients "holistically and not solely in terms of their gender-related distress."
The report notes that identity exploration is "a completely natural process during childhood and adolescence."
Cass recommends that pre-pubertal children and their families have early discussions about how parents can best support their child "in a balanced and non-judgemental way," which may include "psychological and psychopharmacological treatments" to manage distress associated with gender incongruence and co-occurring conditions.
In past interviews, U.S. physicians told ABC News, that patients, their physicians and their families often engage in a lengthy process of building a customized and individualized approach to care, meaning not every patient will receive any or every type of gender-affirming medical care option.
Cass' report states that evidence particularly for puberty blockers in children and adolescents is "weak" regarding the impact on "gender dysphoria, mental or psychosocial health. The effect on cognitive and psychosexual development remains unknown."
The NHS has said it will halt routine use of puberty blockers as it prepares for a study into the practice later this year.
According to the Endocrine Society puberty blockers, as opposed to hormone therapy, temporarily pause puberty so patients have more time to explore their gender identity.
The report also recommends "extreme caution" for transgender youth from age 16 who take more permanent hormone therapies.
"There should be a clear clinical rationale for providing hormones at this stage rather than waiting until an individual reaches 18," the report's recommendations state.
Hormone therapy, according to the Endocrine Society, triggers physical changes like hair growth, muscle development, body fat and more, that can help better align the body with a person's gender identity. It's not unusual for patients to stop hormone therapy and decide that they have transitioned as far as they wish, physicians have told ABC News.
Cass' report asserts that there are many unknowns about the use of both puberty blockers and hormones for minors, "despite their longstanding use in the adult transgender population."
"The lack of long-term follow-up data on those commencing treatment at an earlier age means we have inadequate information about the range of outcomes for this group," the report states.
Cass recommends that NHS England facilities have procedures in place to follow up with 17 to 25-year-old patients "to ensure continuity of care and support at a potentially vulnerable stage in their journey," as well as allow for further data and research on transgender minors through the years.
Several British medical organizations, including British Psychological Society and the Royal College of Paediatrics and Child Health, commended the report's recommendations to expand the workforce and invest in further research to allow young people to make better informed decisions.
“Dr Cass and her team have produced a thought-provoking, detailed and wide-ranging list of recommendations, which will have implications for all professionals working with gender-questioning children and young people," said Dr Roman Raczka, of the British Psychological Society. "It will take time to carefully review and respond to the whole report, but I am sure that psychology, as a profession, will reflect and learn lessons from the review, its findings and recommendations."
Some groups expressed fears that the report will be misused by anti-transgender groups.
"All children have the right to access specialist effective care on time and must be afforded the privacy to make decisions that are appropriate for them in consultation with a specialist," said human rights group Amnesty International. "This review is being weaponised by people who revel in spreading disinformation and myths about healthcare for trans young people."
Transgender care for people under 18 has been a source of contention in both the United States and the United Kingdom. Legislation is being pushed across the U.S. by many Republican legislators focused on banning all medical care options like puberty blockers and hormone therapies for minors. Some argue that gender-affirming care is unsafe for youth, or that they should wait until they're older.
Gender-affirming medical does come with risks, according to the Endocrine Society, including impacts to bone mineral density, cholesterol levels, and blood clot risks. However, physicians have told ABC News that all medications, surgeries or vaccines come with some kind of risk.
Major national medical associations in the U.S., including the American Academy of Pediatrics, the American Medical Association, the American Academy of Child and Adolescent Psychiatry, and more than 20 others have argued that gender-affirming care is safe, effective, beneficial, and medically necessary.
The first-of-its-kind gender care clinic at Johns Hopkins Hospital in Maryland opened in the 1960s, using similar procedures still used today.
Some studies have shown that some gender-affirming options can have positive impacts on the mental health of transgender patients, who may experience gender-related stress.
(NEW YORK) -- From Whole Foods to corner bodegas, fizzy juice drinks from fruity seltzers to reduced-sugar sodas that boast prebiotic and digestive support have exploded in popularity.
But what are the actual benefits of these juices and sodas?
Registered dietitian and nutritionist Maya Feller joined ABC News' Good Morning America on Wednesday to weigh in on the canned beverage consumption trend.
"Flavored sparkling water like Spindrift is literally seltzer water and a splash of real fruit [juice, with] no sugar added or sugar substitutes," Feller said. "[Juice sodas] can have cane sugar and other juice concentrates."
Feller said that Spindrift and other similar sparkling water with real fruit is a great option for consumers looking to enjoy a zero-added-sugar soda alternative, and a good way to stay hydrated.
"Be mindful and intentional," she continued. "Choose the things that have no added sugar."
While juice sodas can be a better alternative to a sugary traditional soft drink, Feller encouraged people to "read the nutrition facts label, be an informed consumer and know what you're drinking."
According to the nutrition page for the popular prebiotic soda Poppi, the drink is a combination of sparking water, organic cane sugar and other juice concentrates, and each drink contains "5 grams of sugar or less."
Similarly, Olipop, a self-proclaimed "healthy" soda that contains prebiotics, plant fiber and botanicals, states on its website that the drinks contain just 2 to 5 grams of sugar.
When it comes to regular fruit juice like orange or apple juice, Feller reminded people to "opt for 100% juice, because there's no sugar added."
Feller recommends drinking just 4 ounces with a meal to "help slow down the sugar absorption into your bloodstream" and avoid a glucose spike.
As for the drinks that boast health support -- such as Olipop or Poppi -- Feller said to "tread lightly."
"I wouldn't say there's anything negative about it," she said, reiterating that it's "a good alternative to sugar sweetened beverages, [but] don't think you're doing yourself this health favor -- because many scientists don't actually agree with these health claims."
"Do your homework -- especially when these are claiming to be good for our health," she added. "When you're having a prebiotic soda, you are not actually adding any extreme nutrients to your overall day. If you want to have it, go for it."
Feller said that she will enjoy a prebiotic soda "once in a while," with the caveat that it's "an intentional and mindful choice."
(NEW YORK) -- Eight-year-old Hannah is winning over audiences and raising awareness for a rare but serious disorder one bite at a time.
Hannah, along with her mother Michelle, has gone viral with her Instagram videos where she tries out little bits of certain food for the first time. She samples everything from mac and cheese to different yogurts, and ranks them on a scale from 1 to 10.
Some days honeydew melon has her fighting back tears; some days a taste of a sweet apple pear is followed by a smile.
The videos have been a form of therapy for Hannah, who suffers from avoidant restrictive food intake disorder, or ARFID, a disorder where a person is afraid of food to the point where they don't want to consume it.
Hannah told ABC News' Nightline that talking about her struggles and finding the right food has helped her push through.
"That helps motivate me," she said. "Whenever I'm trying food, I think about all the people that I'm helping."
Between 0.5% to 5% of children and adults in the general population have ARFID, which was added as an official diagnosis in feeding and eating disorders in 2013, according to the National Eating Disorders Association.
Some research suggests a possible connection with ARFID and conditions like Autism, ADHD and Anxiety, according to the American Psychiatric Association.
The condition is often confused with more common eating disorders like anorexia or bulimia, but ARFID is not about a person’s self-image or drive to be thin, according to mental health experts.
"The people that have this diagnosis have a fear of food, meaning a fear consuming food, [and] a fear of being around food. That can look like a fear of texture, [or] different aversions to smells. It can also present in a form of fear of choking, vomiting, or being allergic to the food," Danielle Gordon, a therapist who specializes in eating disorders, told Nightline.
Gordon diagnosed Hannah with ARFID after her parents sought solutions to her extra picky eating. Michelle told Nightline that they were growing concerned about Hannah's health.
"We noticed when she went to get her physicals at the doctors, and her growth was not increasing at the rate that it was supposed to. She ended up falling off of the growth chart eventually," she said. "Often times she couldn't even be in the same room with us when we were eating."
Gordon recommends exposure therapy to her ARFID patients and Michelle said it has greatly helped her daughter.
"She is on cloud nine," Michelle, who asked Nightline not to disclose her family's last name, said of Hannah. "She's very happy to, you know, prove to herself and prove to everybody else that's watching her that she can do it, and that she can overcome these challenges."
In January, Hannah and Michelle started Hannah's Instagram page and began "My ARFID Life," bringing in fans from around the world, including those who are also living with the condition.
They said they have received so many good comments from people who are also suffering from ARFID but didn't have an outlet for their feelings.
Cassidy Arvidson, 27, of Brooklyn, told Nightline that after she was diagnosed with ARFID three years ago she couldn't find anyone in the community who she could talk to about her struggle.
"ARFID affects my life every single day. It affects my life socially more than anything," she said. "And it is very exhausting dating, specifically. I really do not enjoy. And then other social events like going out with friends, meeting new people, work events."
Arvidson said she was touched and inspired by Hannah's posts.
"She is so brave in doing all the exposures that she does," she said.
Gordon and other advocates hope more can be done to shine a light on ARFID.
"I think that we need to do a better job as an eating disorder community to give ARFID as much of a spotlight as the other disorders," she said. "And even research-wise, we need to do more work around this area to really help people and provide proper treatment for all."
(NEW YORK) -- The Environmental Protection Agency on Wednesday announced a new rule mandating the first-ever national standard for the presence of so-called "forever chemicals" in drinking water.
The new standard limits six types of per- and polyfluoroalkyl substances, or PFAS, found in drinking water -- a move the EPA says will protect around 100 million people from exposure.
"Today, I'm extremely excited to announce that we are finalizing the first ever nationwide, legally enforceable drinking water standard for PFAS -- the most significant action on PFAS the EPA has ever taken," EPA Administrator Michael Regan said during a call with reporters. "This standard will reduce PFAS exposure to approximately 100 million people."
PFAS are a ubiquitous group of chemicals found in a host of industrial and personal products, including fire extinguishing foam, food packaging, dental floss and others, according to the EPA.
The chemicals break down very slowly, allowing them to build up in people, animals and the environment over time -- hence the nickname, "forever chemicals."
"This rule really is a breakout from where we've been for decades," Erik Olson, senior strategic director for health at the Natural Resources Defense Council, told ABC News. "Finally, we're seeing government start to take the PFAS crisis seriously."
The EPA says it expects 6% to 10% of the 66,000 public drinking water systems in the U.S. may have to reduce PFAS from their water systems to meet the new standard.
Under this rule, water systems across the country will have three years to monitor for these chemicals and an additional two years to implement new technology to reduce their PFAS levels.
One billion in funding from the Bipartisan Infrastructure Law will be available to help states and territories with testing and treatment for PFAS as they work to come into compliance over the next few years.
By reducing PFAS exposure for millions of Americans, the Biden administration says this new standard will also prevent severe illness and death for many Americans.
"One hundred million people will be healthier and safer because of this action," Regan said. "This action will prevent thousands of deaths and tens of thousands of serious illnesses."
PFAS exposure has been linked to increases in cholesterol, changes in liver enzymes and pregnancy complications like preeclampsia, among other issues, according to the Centers for Disease Control and Prevention.
"Every single person in the United States is walking around with PFAS in their bodies," Olson said. "The risks are very real. These EPA rules will start the process of controlling the risks from tap water."
The chemicals targeted by the EPA in this rule include five individual PFAS: PFOA, PFOS, PFNA, PFHxS, and HFPO-DA. These five are also known as "GenX Chemicals." The rule also targets mixtures of two or more of four PFAS: PFNA, PFHxS, PFBS, and "GenX chemicals."
Olson noted that a large area in North Carolina famously became polluted with GenX Chemicals after a chemical plant spent decades dumping PFAS into the Cape Fear River.
"There's still only six that EPA is regulating, which is a good step, but they are 14,000 of these PFAS," Olson said. "So, we're taking a bite out of the problem, but we really need to regulate this whole class of toxic chemicals together because if we keep regulating them a few at a time, we're just never going to get off the toxic treadmill and never going to catch up with all the new chemicals the industry keeps producing and exposing us to."
Some industry groups opposed the rule during its public comment period.
The American Chemistry Council released a statement last summer criticizing the EPA's plan, saying the assessment of health impacts the agency relied on for its analysis was flawed and that it underestimated the cost of compliance for water systems.
Biden administration officials say they expect continued opposition under the finalized standards, but that they designed the rule to withstand potential challenges.
"We feel very confident that we have designed a very durable rule, well within our statutory authority, that begins to protect people from harmful pollutants that are showing up in their drinking water," a senior administration official said. "This is something that we've done in concert with our sister agencies. It's a government wide effort, and we're very proud of the product that we are releasing today."
(NEW YORK) -- Theo Huot de Saint-Albin was a 9-year-old elementary school student when he first contracted COVID-19 in July 2020, near the start of the coronavirus pandemic.
Four years later, as much of the world has moved on from the pandemic and resumed normal life, Theo, now nearly a teenager, is still battling the effects of long COVID.
"What happened directly after COVID-19 was worse than my actual COVID-19," Theo, now in seventh grade, told ABC News' Good Morning America. "For me, I have chronic migraines ... it doesn't mean the migraine is terrible every day. It's very unpredictable. It goes in waves. But it's always there. It never leaves."
Over the past four years, Theo has contracted COVID-19 a total of three times, and each case has been mild. It's what happens in the weeks and months after the COVID-19 diagnosis that he says has impacted his ability to learn, go to school and play with friends.
In addition to battling chronic migraines, Theo was also diagnosed with postural orthostatic tachycardia syndrome, or POTS, a blood circulation disorder that can cause dizziness, lightheadedness and a rapid heartbeat, according to the U.S. National Institute of Neurological Disorders and Stroke.
He said he also suffers from symptoms like muscle pain, extreme fatigue and brain fog, and takes around two dozen medications and supplements each day to help manage his symptoms.
"There's no real way to tell how I'm going to feel," Theo said, noting that some days he is able to go to school for only a half-day, while other days he feels closer to his pre-COVID-19 self, and still others he can't move beyond the couch all day.
"It's especially hard because it's 'invisible,'" Theo said of his long COVID diagnosis. "Sometimes it's hard to get people to believe you as well because they can empathize with something they know is there. 'Oh, you have a broken leg, I can see that. Wow, you can't walk. That must be tough.' But, your head hurts? 'I don't see a big bulge on your head. I don't see bandages wrapped around it.'"
An 'invisible' condition impacting potentially millions of kids
While battling long COVID can seem lonely, Theo is far from alone, data shows.
An analysis published in February in the journal Pediatrics reported that as many as 5.8 million children in the United States have developed long COVID, or between 10% to 20% of children who have contracted COVID-19.
Figures from the Centers for Disease Control and Prevention show a smaller but still noteworthy estimate of 1.3% of children in the U.S. having had long COVID as of 2022.
Long COVID is diagnosed when patients still have symptoms at least four weeks after they have cleared the infection, according to the CDC. In some cases, like Theo's, symptoms can be present for months or years.
It's not clear if long COVID symptoms last a lifetime. Many people eventually recover, but scientists are still working to understand who is most affected, and why.
Symptoms vary and can include fatigue, difficulty breathing, headaches, dizziness brain fog, joint and muscle pain and continued loss of taste and smell, according to the CDC.
In kids, symptoms of long COVID can also include rashes, diarrhea, heart issues and diabetes, according to the research published in Pediatrics.
Part of the complication with long COVID is there is no single test or bloodwork to diagnose it. Instead, doctors have to rule out other conditions and rely on patients to describe and track their symptoms, which can be difficult with kids.
For Theo, it took nearly two years for him to be diagnosed with long COVID, according to his mom Meredith Eubanks.
Eubanks said she was told "no" by doctors when she would ask if her son might have long COVID, and faced misdiagnoses along the way, like Lyme disease. Both she and Theo struggled to answer when asked roughly how many doctors he had seen over the past four years.
In April 2022, Eubanks said Theo was diagnosed with long COVID by an infectious disease group at a local children's hospital in Atlanta, where the family lives. But the hospital, according to Eubanks, had no answer to her question of "Now what?" in terms of treatments and rehabilitation.
For that, the family traveled over 600 miles to Baltimore, where Dr. Laura Malone, a pediatric neurologist, had established the Pediatric Post-COVID-19 Rehabilitation Clinic at the Kennedy Krieger Institute, a pediatric-focused nonprofit health organization affiliated with Johns Hopkins Medicine.
"They were the first place we got to where they were like, 'Here's a list of symptoms, and did you have any pre-COVID, and what did you have post-COVID?'" Eubanks said, recalling how Theo checked nearly all of the symptoms on the list. "I just remember that was such relief. It was just like, 'Oh, you know, they're recognizing this and it's official, and Theo is not alone.'"
Malone said she and her team at the Kennedy Krieger Institute established the clinic in the summer of 2020 as they saw reports of adults developing long COVID. As the pandemic continued, demand began to grow.
"Everybody was, early in the pandemic, very focused on hospitalized cases, and the sequela after people get care in the ICU or are very critically ill with the acute infection, and that's not generally what we see in pediatrics," Malone said. "Most children can have a relatively mild infection and then go on to develop long-term sequela. So, that took a little bit of time to recognize and for patients to seek care, both from their primary care doctors and then also from clinics like us."
As long COVID became more recognized, Malone said the clinic has seen steady demand from pediatric patients across the country, while she said other patients may go undiagnosed.
"You have to look at a lot of behavioral changes, especially in younger children, to say, 'Something seems off'.' So I do think that [long COVID] is probably a little bit under-recognized still," Malone said. "We do see that there can be a lot of resiliency in children, and so despite them sometimes maybe having the symptoms, they may not always bring it up to family members or doctors but rather just try and manage the symptoms, and it's only when it gets to be intolerable that sometimes it will present to more medical care."
Helping kids return to 'normal' life
Along with there being no diagnostic test for long COVID, there is also no cure for the condition. Much of what can be done for patients is symptom management, according to Malone.
For kids, she said that means helping them manage their symptoms so they can, at least to some degree, return to school and social activities.
"Participation in life and all the activities, including education, that kids are designed to be participating in is really important," Malone said. "One of our big focuses is to try to provide accommodations to get kids back into school, but meet them where they are, because they may not be able to do a full course load, or they may not be able to make it through the full day of school, but there is still benefit if they can go for an hour, and gradually increase that over time to getting them back into that sort of routine, and getting them back into the social aspects of school and the educational aspects."
Patients at the clinic see not only medical doctors like Malone, but a team of experts including behavioral and neuropsychologists, social workers, pain specialists and physical therapists.
Ellen Henning, Ph.D., a pediatric psychologist at the Kennedy Krieger Institute, said patients often struggle with anxiety and depression due to long COVID. She said new research is also suggesting that long COVID itself could be influencing mental health symptoms due to factors like inflammation in the brain and lower levels of serotonin.
"We learn new things constantly and we adjust as we as we go," Henning said. "We try to provide the best supports that we can and then we all are always integrating new knowledge and adjusting things as we need to."
In October, the clinic received a $5 million grant from the Department of Health and Human Services that it is using to help train school nurses and other community health care providers to identify long COVID in students and provide accommodations for students already diagnosed with the condition.
"We have a lot of families and children that say that they have to educate, sometimes, their providers and tell their doctors at home about what's going on and about long COVID," Malone said. "That can just be really exhausting for kid, so that's a big thing that we've been working on, and we're really proud of that."
Theo said while his long COVID symptoms continue, he has felt more at ease since receiving his diagnosis and as the condition becomes more recognized.
With the help of Malone and the team at the Kennedy Krieger Institute, Theo is back in school for periods of time and working on catching up with his classmates.
"We have a lot of hope," he said. "I know I'm going to finish school at some point. Maybe a little later than most people, but who knows. And I think I'm going to get better. With all the research that's going to come out, hopefully, something will help me more than anything else."
(NEW YORK) -- Aruba Aloe Balm N.V. has issued a voluntary recall of some of its hand sanitizer products due to the presence of alcohol denatured with methanol, which poses significant health risks to consumers.
Forty lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel were found to have contained methanol, the company said Friday in a press release in conjunction with the U.S. Food and Drug Administration.
"Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk for methanol poisoning," the company said in a statement.
The company said there have been no reported adverse events related to these products thus far, but methanol exposure can lead to severe consequences, including nausea, vomiting, headache, blurred vision, coma, seizures, permanent blindness, and even death.
Aruba Aloe Hand Sanitizer Gel comes in 12 fl oz (355 mL) dark green plastic bottles with a white label. The label reads in part, "ARUBA ALOE Hand Sanitizer GEL 80% Alcohol Made in Aruba World’s Finest Aloe" with the barcode 0 82252 03300 5. The recall affects specific lot numbers distributed between May 1, 2021, and Oct. 27, 2023.
Aruba Aloe Alcoholada Gel, used for pain relief and itching associated with minor burns, sunburn, insect bites, or minor skin irritations, comes in two sizes: 2.2 fl oz (65 mL) and 8.5 fl oz (251 mL) plastic bottles. The bottles have barcodes 0 82252 34030 1 and 0 82252 03120 9, respectively. Lot numbers for this product are also included in the recall, covering the same distribution period.
These products were sold exclusively online via the Aruba Aloe Balm N.V. website during the specified distribution timeframe.
ABC News' Good Morning America has reached out to Aruba Aloe Balm N.V. for further comment.
Aruba Aloe Balm N.V. has taken steps to notify customers who purchased these product lots via email and is offering a discount coupon for a future purchase as compensation. However, consumers with these recalled products are strongly advised to discontinue use immediately and dispose of them properly by taking them to your nearest Household Hazardous Waste Recycling & Disposal center.
Aruba Aloe Balm N.V. said in their release that those with concerns or questions regarding this recall and announcement can contact the company via email at recall@arubaaloe.com.
Additionally, consumers who have experienced any adverse reactions or quality problems associated with these products are encouraged to report them to the FDA's MedWatch Adverse Event Reporting program.
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