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FDA responds to possible link between autism and paracetamol

2025-09-23 11:20:01Aktualitet SHKRUAR NGA REDAKSIA VOX

FDA responds to possible link between autism and paracetamol

The U.S. Food and Drug Administration (FDA) on Tuesday began the process of changing the label for acetaminophen (products such as Tylenol or paracetamol as it is known in Europe), supporting evidence that the use of the drug by pregnant women may be linked to an increased risk of developing neurological disorders, such as autism and ADHD, in children. In addition, the agency sent a warning letter to doctors across the United States.

“The FDA is taking steps to inform parents and physicians about the substantial body of evidence about the potential risks associated with acetaminophen,” said FDA Commissioner Marty Makary, MD, MPH.

"Although this evidence exists, the ultimate decision rests with the parents. The precautionary principle may lead many to avoid the use of acetaminophen during pregnancy, especially since most mild fevers do not require treatment. However, it is reasonable for pregnant women to use acetaminophen in certain situations," the FDA announced.

In recent years, several large studies, including the Nurses' Health Study II and the Boston Birth Cohort, have found a link between acetaminophen use during pregnancy and later diagnosis of conditions such as autism and ADHD. Some of these studies suggest that the risk is higher when the drug is used chronically throughout pregnancy.

However, it is important to note that, although an association between acetaminophen and neurological disorders has been observed in some studies, a causal relationship has not been confirmed, and there are also studies in the scientific literature that do not support this association. Also, acetaminophen is the only over-the-counter drug approved for the treatment of fever during pregnancy, which can be dangerous to the fetus. In addition, aspirin and ibuprofen have documented adverse effects on the fetus.


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