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FDA Warning: Thyroid Drug Linked to Liver Disease -
Agency Issues Recommendations for Propylthiouracil Use
American Family Physician, 06/08/09
Propylthiouracil generally is considered second-line drug therapy for this indication and typically is used in patients who cannot tolerate methimazole. Because methimazole has been associated with rare cases of embryopathy, including aplasia cutis, propylthiouracil may also be preferred for patients with Graves disease who are in their first trimester of pregnancy. 32 cases of serious liver injury associated with the use of propylthiouracil had been reported to MedWatch, the agency's Safety Information and Adverse Event Reporting Program, through October 2008. Propylthiouracil should not be used in pediatric patients unless the patient cannot tolerate methimazole and no other treatment options are available. Physicians should counsel patients to advise them if they experience any of the following symptoms: fatigue, weakness, vague abdominal pain, loss of appetite, itching, easy bruising, or yellowing of the eyes or skin. If liver injury is suspected, propylthiouracil therapy should be discontinued and the patient evaluated for evidence of liver injury.
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