A boxed warning has been added to the hyperthyroidism drug propylthiouracil (PTU) to alert clinicians about the drug's risk for severe liver injury, the FDA announced on Wednesday.
The new labeling is based in part on postmarketing safety reports of severe liver injury — including 15 deaths — in 23 adult and 11 pediatric patients taking PTU. A warning about the potential dangers of the drug was issued by the agency last June.
The FDA recommends that PTU only be used in patients who cannot tolerate methimazole or other treatments for hyperthyroidism and in women just before and during their first trimester of pregnancy.
Patients will now receive a medication guide upon filling a prescription for PTU.
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