NEWS - Propylthiouracil linked with risk for serious liver damage, death

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Propylthiouracil Linked With Risk for Serious Liver Damage, Death

June 3, 2009 — The US Food and Drug Administration (FDA) issued a

safety alert today about the risk for serious liver damage, including

liver failure, or death with propylthiouracil (PTU) compared with

methimazole. Both agents are approved for the treatment of

hyperthyroidism associated with Graves' disease.

“Health care professionals should carefully consider which drug to

initiate in a patient recently diagnosed with Graves’ disease, " Amy

Egan, MD, deputy director for safety, Division of Metabolism and

Endocrinology Products, in the FDA’s Center for Drug Evaluation and

Research, said in a news release. " If PTU therapy is chosen, the

patient should be closely monitored for symptoms and signs of liver

injury, especially during the first six months after initiating

therapy.”

Physicians should promptly discontinue PTU therapy when liver damage

is suspected; such patients should be evaluated and supportive care

provided if needed.

The agency notes that 22 adult cases and 10 pediatric cases of serious

liver injury linked to PTU use have been reported to its Adverse Event

Reporting System. Twelve of the adult patients died and 5 required

liver transplantation. In the pediatric cases, 1 child died and 6

required liver transplantation. In contrast, only 5 cases of serious

liver injury associated with methimazole use have been reported. These

cases, all in adults, resulted in 3 deaths.

" PTU is considered second-line drug therapy except in patients who are

allergic to or intolerant of methimazole, " according to an alert from

MedWatch, the FDA's safety information and adverse event reporting

program. " Rare cases of embryopathy, including aplasia cutis, have

been reported with use of [methimazole] during pregnancy, while no

such cases have been reported with PTU use. Thus, PTU may be more

appropriate for patients with Graves' disease who are in their first

trimester of pregnancy. "

" PTU 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, " the FDA points out.

Any adverse events associated with PTU should be communicated to the

FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by

fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by

mail to 5600 Fishers Lane, Rockville, land 20852-9787.

http://www.medscape.com/viewarticle/703851

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