Tylenol during pregnancy has no link to autism, large study finds
In this stock image, an open bottle of Tylenol Extra Strength pain reliever is shown. (STOCK IMAGE/Getty Images)
(NEW YORK) — Taking acetaminophen, also known by the brand name Tylenol, during pregnancy had no effect on children developing autism, according to a study of over 1.5 million children in Denmark published this week.
The study was published in JAMA Pediatrics.
Researchers analyzed 1.5 million children born between 1997 and 2022. About 1.8% of those who were exposed to Tylenol during pregnancy developed autism compared to 3.0% of those who were not exposed to Tylenol.
A prior study out of Sweden looked at siblings, finding no causal link between autism and Tylenol exposure during pregnancy. There are genetic associations and environmental triggers that are likely involved, but neither Tylenol nor vaccines has been shown to be the cause of autism.
The new study out this week comes after President Donald Trump and his administration had previously urged pregnant mothers to avoid Tylenol, without substantive evidence for the claims.
“With Tylenol, don’t take it. Don’t take it,” Trump said during a press event at the White House in September. “If you can’t live, if your fever is so bad, you have to take one, because there’s no alternative to that.”
The FDA then initiated a process to update the safety label on acetaminophen to suggest that its use during pregnancy and autism were linked.
At the time, Kenvue, the maker of Tylenol, wrote in part of a statement, “We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.”
At the time, medical organizations, like the American College of Obstetrician & Gynecologists, immediately pushed back, noting that Tylenol was one of the few options for pregnant women to treat pain and fever, which can be harmful when left untreated.
It is generally not recommended for pregnant women to take ibuprofen, Advil, during pregnancy due to the risk of complications.
Nevertheless, the claims made by the administration have led to confusion. A prior study found that Tylenol use in emergency departments dipped 16% immediately following the announcement by the administration.
ABC News reached out to Kenvue, the maker of Tylenol, for a statement but did not immediately hear back.
A hantavirus is a virus found in the urine, saliva or excrement of deer mice and certain other infected wild rodents (Icy Macload/Getty Images)
(LONDON and BELGRADE, Serbia) — The total number of suspected hantavirus cases aboard a cruise ship has risen to five as global health authorities work to contain a potentially deadly cluster of the disease.
More than 100 passengers remain on the ship and the World Health Organization (WHO) is monitoring their health. Officials said that the “overall public health risk remains low” but that there may be some person-to-person spread.
The ship, the MV Hondius, which was off the coast of Africa in Cape Verde, is now en route to the Canary Islands after officials medically evacuated three people, including two in “serious condition.”
Some passengers disembarked the ship before knowledge of the cluster and are back in their home countries. In some cases, authorities are advising those passengers to self-isolate.
In addition to the two patients who were evacuated, a third person, who is asymptomatic but a close contact of a German national who died on May 2, was also removed from the ship, WHO officials in Cape Verde told ABC News.
“WHO continues to work with the ship’s operators to closely monitor the health of passengers and crew, working with countries to support appropriate medical follow-up and evacuation where needed,” Dr. Tedros Adhanom Ghebreyesus, the director-general of the WHO, said in a post on X on Wednesday, in which he confirmed the evacuations.
“Monitoring and follow-up for passengers on board and for those who have already disembarked has been initiated in collaboration with the ship’s operators and national health authorities,” he continued.
Tedros added that “the overall public health risk remains low.”
Health officials confirmed two additional cases of hantavirus among crewmembers, bringing the total confirmed cases to five.
The three previously confirmed hantavirus cases include a woman who disembarked and was on her way home from the Netherlands, a British national who is in critical but stable condition in a hospital in Johannesburg, and a passenger who traveled on the first leg of the voyage and is currently being treated at the University Hospital Zurich, according to Oceanwide Expeditions, which operates the ship. So far, three deaths have been recorded.
“Swiss authorities have confirmed a case of hantavirus identified in a passenger from the MV Hondius cruise ship,” the WHO said on X on Wednesday. “He had responded to an email from the ship’s operator informing the passengers of the health event, and presented himself to a hospital in Zurich, Switzerland, and is receiving care.”
The type of virus in this outbreak has been confirmed as Andes hantavirus by the National Institute for Communicable Diseases in South Africa and Geneva University Hospitals in Switzerland, the WHO said Wednesday. The Andes hantavirus historically has been shown to potentially transmit between people, according to the WHO.
Oceanwide Expeditions said of the three passengers who were evacuated from the ship, two are symptomatic and in serious condition and the third is asymptomatic but a close contact of a German national who died on May 2.
“In partnership with the RIVM (Dutch Institute for Public Health and Environment), Oceanwide Expeditions is expanding medical care on board with two infectious disease physicians, arriving today by plane from the Netherlands. This ensures that optimal medical care can be provided if necessary, during the next stage of this evolving situation,” the company said in a statement.
Cape Verde officials said on Tuesday that the vessel was expected to sail to the Spanish island of Tenerife, but the president of the Canary Islands, a Spanish archipelago off the northwestern coast of Africa, said on Wednesday that the regional government was opposed to allowing the luxury cruise ship to dock in Tenerife.
“This decision is not based on any technical criteria, nor is there sufficient information to reassure the public or guarantee their safety,” President Fernando Clavijo told radio station COPE, according to Reuters.
Clavijo said on social media that he had requested a meeting with the Spanish prime minister to discuss the ship. He added that the Canary Islands “always acts with responsibility, but it cannot accept decisions taken behind the backs of the Canary Islands institutions and without sufficient information to the population.”
Mónica García, Spain’s minister of health, said once the ship arrives at the port of Granadilla de Abona in the Canary Islands, there will be a “joint screening and evacuation mechanism will be launched to repatriate all passengers,” according to RTVE, a Spanish national public broadcaster.
“Unless their medical condition prevents it, all foreign passengers will be repatriated through the European civil protection mechanism, about which the Interior Minister will provide further details later,” Garcia said in Spanish.
WHO officials earlier on Wednesday said the three evacuated people were to be transferred to planes bound for both the Netherlands and Tenerife, but later updated the plan so that all would be sent to the Netherlands, officials told ABC News.
(MASSACHUSETTS) — A Massachusetts judge ruled on Monday in favor of medical organizations in their litigation against Health and Human Services Secretary Robert F. Kennedy Jr. over his changes to federal vaccine policy.
The judge temporarily blocked changes to the childhood vaccine schedule that were made at the beginning of this year, in which Kennedy reduced the number of recommended shots from 17 to 11.
The judge also suspended the appointments of the 13 members of the Centers for Disease Control and Prevention’s vaccine advisory committee, who were all appointed unilaterally by Kennedy after he fired all the preceding members.
This is a developing story. Please check back for updates.
Psilocybin mushrooms stand ready for harvest in a humidified “fruiting chamber” in the basement of a private home on July 28, 2023 in Fairfield County, Connecticut. (John Moore/Getty Images)
(NEW YORK) — The Food and Drug Administration (FDA) announced on Friday It’s issuing national priority vouchers to three companies to help fast-track the review of certain psychedelic medications.
The companies are studying psilocybin for treatment-resistant depression and major depressive disorder and methylone for post-traumatic stress disorder (PTSD).
These vouchers mean the FDA has 60 days to review the medications for approval.
“These medications have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions,” FDA Commissioner Dr. Marty Makary said in a press release.
“As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence,” the statement continued. “We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.”
The agency also announced it is allowing an early phase clinical study of noribogaine hydrochloride, the principal psychoactive substance of the drug ibogaine, to move forward following an Investigational New Drug submission.
This is the first time the FDA has allowed a clinical study in the U.S. of a derivative of ibogaine, which is derived from the African Tabernanthe iboga shrub, the press release said.
Noribogaine hydrochloride is being investigated as a potential treatment for alochol use disorder, according the FDA.
The FDA also said it intends “to release final guidance imminently to provide recommendations to sponsors developing these products” which will include recommendations for study design, data collection and patient monitoring.
“There is a growing recognition of the potential of psychedelic medications to address multiple different psychiatric conditions that are notoriously difficult to treat,” said Dr. Tracy Beth Hoeg, acting director of the FDA’s Center for Drug Evaluation and Research. “At the FDA we are showing our support of investigating the safety and efficacy of this class of drugs through today’s actions.”
The announcement comes after President Donald Trump signed an executive order over the weekend directing the FDA to expedite its review of certain psychedelics.
The order aims to accelerate research and approval of psychedelic-based therapies to help treat mental health conditions including PTSD, depression and addiction.
Currently, there are no classic psychedelic drugs approved for routine psychiatric care in the U.S.
A multitude of studies have suggested that psychoactive drugs, including cannabis, ketamine, psilocybin and midomafetamine (MDMA), may help treat PTSD and other mental health disorders.
However, most of these drugs are classified as Schedule I, meaning they have “no currently accepted medical use and a high potential for abuse,” according to the Drug Enforcement Administration.
A 24-person 2022 study from John Hopkins Medicine followed patients with moderate to severe major depressive disorder who received psilocybin-assisted treatment for up to a year. Psilocybin is the main psychoactive ingredient in magic mushrooms.
Researchers found antidepressant effects from psilocybin and supportive psychotherapy may last at least a year in some patients. Administration required close monitoring in a controlled setting with a trained provider.
MDMA has shown some early promise in treating PTSD. However, in June 2024, a panel of independent advisers for the FDA voted against recommending approval of pharmaceutical version of MDMA — along with therapy — to treat the condition.
The Psychopharmacologic Drugs Advisory Committee appeared to have doubts about the safety and efficacy of the treatment, with the majority voting “no” on questions of data showing the drug is effective and that the benefits of MDMA outweigh the risks for the treatment of patients with PTSD.
Methylone is a synthetic stimulant related to MDMA that affects mood and energy but carries risks of addiction, heart strain, and other serious side effects.
ABC News’ Liz Neporent contributed to this report.
