FDA warns of serious AEs with anti-thyroid drug

4 June 2009

The US Food and Drug Administration has warned health care professionals about the risk of serious liver injury associated with the use of the  anti-thyroid drug propylthiouracil for the treatment of Graves'  disease.

After analyzing adverse event reports, the agency identified an  increased risk of liver injury with the drug, which is sold by Canadian  firm Paladin Labs as Propyl-Thyracil, when compared to an alternative  treatment for the autoimmune thyroid disorder, methimazole.

Amy Egan, of the FDA's Center for Drug Evaluation and Research, said:  "health care professionals should carefully consider which drug to  initiate in a patient recently diagnosed with Graves' disease. If  propylthiouracil therapy is chosen, the patient should be closely  monitored for symptoms and signs of liver injury, especially during the  first six months."

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