FDA to Initiate Process for Safety Label Change on Acetaminophen: RFK Jr.

The federal government is taking steps to warn doctors and patients about possible risks linked to one of the nation’s most commonly used pain medications.

Health and Human Services Secretary Robert F. Kennedy said Monday that the Food and Drug Administration (FDA) will issue a physicians’ notice on the potential dangers of using acetaminophen during pregnancy and begin the process of adding a new safety warning label.

The move comes in response to growing scientific concern over whether acetaminophen — widely sold under brand names like Tylenol — may be associated with developmental disorders such as autism when taken by expectant mothers. Although acetaminophen has long been considered safe for use in pregnancy when used as directed, some recent studies have raised questions about its possible impact on fetal brain development.

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