Introduction to Autism and Acetaminophen
President Donald Trump said Monday the Food and Drug Administration approved a chemotherapy drug called leucovorin as a treatment to alleviate symptoms of autism, despite little evidence that the medication works. Trump also said the administration is issuing a warning to doctors not to recommend acetaminophen — the active ingredient in Tylenol and other widely used medications— for pregnant women, claiming it may be linked to autism in children.
Background on the Announcement
Trump had been teasing the announcement for days, as Health Secretary Robert F. Kennedy Jr. and other health officials have pledged to determine the cause of the developmental disorder by September. The administration had planned to release its long-awaited report on causes of autism around Sept. 29 or Sept. 30, a person familiar with the matter told NBC News. But Trump preempted the rollout over the weekend, and details soon appeared in the Washington Post.
The Claim on Acetaminophen and Autism
“We understood a lot more than a lot of people who studied it,” Trump said from the White House, referring to autism. He spoke alongside Kennedy, Food and Drug Administration Commissioner Marty Makary, National Institutes of Health Director Jay Bhattacharya and Centers for Medicare and Medicaid Services Administrator Mehmet Oz. “Taking Tylenol is not good,” Trump said. “I’ll say it. It’s not good.”
Leucovorin as a Treatment for Autism
Leucovorin is a drug approved by the FDA to counteract the side effects of certain chemotherapy drugs and sometimes used off-label to treat vitamin B9 deficiency. Leucovorin is a form of folinic acid, a B vitamin. The drug has shown promise in clinical trials with helping some children with autism improve their speech. But the Autism Science Foundation, which funds evidence-based autism research, does not recommend it as a treatment yet and says more studies are needed. Trump said the FDA on Monday updated the drug’s label for the treatment of autism symptoms.
Medicaid Coverage for Leucovorin
Oz said Medicaid — in partnership with states — will cover the medication with a prescription. “We believe insurance companies will rapidly follow our lead,” Oz said. Kennedy also said the FDA will issue a letter to health care providers advising that the over-the-counter medication should be used during pregnancy only in cases of high fever, when the fever itself may pose a health risk to the fetus.
Research on Autism and Acetaminophen
Bhattacharya said at Monday’s briefing that the NIH will dedicate $50 million to 13 research projects focused on identifying root causes and treatments for autism, an effort known as the “autism data science initiative.” The research will focus on environmental and medical factors, nutrition, events during pregnancy, biology and genetics, he said. “Given this wide range of symptoms across the spectrum, it seems certain that there will be a wide range of biological contributors to explaining the cause,” he said.
Expert Opinions on the Claim
Researchers who’ve spent decades researching potential causes of autism say the administration hasn’t uncovered any new evidence — and the existing data still doesn’t support its claims. “This is not new,” Dr. Allison Bryant, a high-risk obstetrician at Massachusetts General Hospital in Boston, said in an earlier interview “It has bubbled up every now and again with studies that show maybe some kind of association, but not clearly showing any cause and effect.” Experts say autism spectrum disorder, which is characterized by challenges with social and speech skills and by repetitive behaviors, likely stems from multiple factors rather than a single cause.
The Use of Acetaminophen During Pregnancy
Acetaminophen was first introduced in the U.S. in the 1950s as a prescription alternative to aspirin. By the 1970s, it was made available over the counter and became one of the most commonly used pain and fever medications in the country. The American College of Obstetricians and Gynecologists and other major medical groups say acetaminophen is one of the only safe pain relievers for women during pregnancy, and studies have shown no clear evidence that use during pregnancy leads to developmental issues in kids. The drug is also found in brand-names like Theraflu and Exedrin. Between 40% to 65% of women use acetaminophen at some point during pregnancy, according to a 2014 study published in the American Family Physican.
Conclusion
The Trump administration’s claim that acetaminophen use during pregnancy may cause autism has sparked controversy among experts. While some studies suggest a possible link, others have found no evidence to support this claim. The FDA’s decision to update the label for leucovorin and issue a warning about acetaminophen use during pregnancy has been met with skepticism by many in the medical community. Further research is needed to determine the safety and efficacy of these medications.
FAQs
- What is the claim made by the Trump administration regarding acetaminophen and autism?
The Trump administration claims that acetaminophen use during pregnancy may be linked to autism in children. - What is leucovorin and how is it related to autism?
Leucovorin is a chemotherapy drug that has shown promise in clinical trials in helping some children with autism improve their speech. - Will Medicaid cover leucovorin for autism treatment?
Yes, Medicaid will cover leucovorin with a prescription. - What do experts say about the claim that acetaminophen use during pregnancy causes autism?
Experts say that the existing data does not support the claim that acetaminophen use during pregnancy causes autism. - How common is the use of acetaminophen during pregnancy?
Between 40% to 65% of women use acetaminophen at some point during pregnancy, according to a 2014 study published in the American Family Physican.
