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President Donald Trump and Robert F. Kennedy, Jr., secretary of health and human services, announced on 22 September 2025, that the Federal Drug Administration will begin warning women against taking acetaminophen during pregnancy, with a few exceptions. The announcement coincides with the Trump administration's release of a report purportedly finding a potential link between prenatal use of acetaminophen and the development of autism spectrum disorder (ASD).
Allegations that prenatal use of acetaminophen increases the risk of ASD and attention deficit hyperactivity disorder in children are not entirely new. A handful of observational studies claimed to find a connection as far back as 2021, which later led to litigation against manufacturers and retailers of acetaminophen products. However, the scientific evidence supporting the alleged connection is hotly debated and largely considered inconclusive within the scientific and autism research community.
In 2023, the Judicial Panel on Multidistrict Litigation consolidated more than 500 lawsuits in federal court into In re Acetaminophen (MDL 3043) in the United States District Court for the Southern District of New York. The judge overseeing the MDL dismissed all claims in August 2024 after ruling that the scientific evidence supporting the connection was insufficiently reliable. The dismissal is currently on appeal before the United States Court of Appeals for the Second Circuit.
In light of President Trump and Secretary Kennedy's announcement, there is likely to be an increase in scrutiny regarding research into the acetaminophen-ASD connection and an upsurge in litigation related to manufacturers, retailers, distributors, and other entities historically involved in the sale of acetaminophen. Accordingly, companies involved in the industry should continue to monitor developments closely and consult with legal counsel as appropriate.
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