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FDA Warns of Propylthiouracil-Induced Liver Injuries | cialis online

FDA Warns of Propylthiouracil-Induced Liver Injuries

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The Food & Drug Administration (FDA) is warning that the Graves’ disease drug, Propylthiouracil, has been linked to serious liver injuries and death.

In a health alert issued yesterday, the agency advised health care professionals to carefully consider whether to  initiate treatment with propylthiouracil, or an alternative called methimazole  in a patient recently diagnosed with Graves’ disease. Physicians should closely monitor patients on propylthiouracil therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy, the agency said.  The agency also warned that propylthiouracil  should not be used in pediatric patients unless the patient is allergic to or intolerant of methimazole, and there are no other treatment options available.

In its alert, the FDA said it was working  to make changes to the drug’s prescribing information to reflect this risk, particularly for use in pediatric patients.

According to the FDA, there were 32 reports of serious liver injuries occurring in patients taking propylthiouracil between 1969 and October 2008.  Of those, 10 liver injuries occurred in children.  Of the adult cases, 12 deaths and five liver transplants occurred.  Among the pediatric patients, one case resulted in death and six in liver transplants. In contrast, only five cases of serious liver injury associated with methimazole use have been reported. These cases, all in adults, resulted in three deaths.

Propylthiouracil, which has been on the market since 1947, is a second-line therapy for overactive thyroid related to Graves’ disease.  It is used when patients are allergic to or intolerant of methimazole.  It is also given to pregnant women with the disorder, as methimazole has been linked to complications when taken during pregnancy. Because of the pregnancy complications associated with methimazole, the FDA’s alert noted that propylthiouracil may be a more appropriate for patients with Graves’ disease who are in their first trimester of pregnancy.

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