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Propylthiouracil Liver Damage Lawsuit

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If you use propylthiouracil to treat an overactive thyroid or Graves' disease, and you have suffered a liver injury, you should know that this drug could be to blame. Since 1969, dozens of people using propylthiouracil - including children - have been stricken with a serious liver injury.   Some victims have required liver transplants, and 13 people have died because of this medication. One of those deaths involved a child.

FDA Warning on Propylthiouracil

Propylthiouracil was first approved in 1947. It is a second line treatment for overactive thyroid related to Graves' disease. Propylthiouracil is used to treat patients who are allergic to or intolerant of methimazole. It is also used to treat overactive thyroid from Graves' disease in pregnant women, as methimazole has been associated with rare cases of embryopathy, including aplasia cutis, when used during pregnancy. 

In May 2009, the Food & Drug Administration (FDA) informed healthcare professionals about the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil in adult and pediatric patients. The FDA said it had received reports of 32 cases (22 adult and 10 pediatric) of serious liver injury associated with propylthiouracil use between 1969 and October 2008.  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. 

Meanwhile, in patients treated with methimazole, only five cases of serious liver injury were identified.  All five cases were in adult patients and three resulted in death. 

Because of the risks associated with propylthiouracil, the FDA has advised that healthcare professionals should carefully consider which drug to initiate 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. 

Because of the risks associated with methimazole in pregnancy, the agency also said that propylthiouracil may be more appropriate for patients with Graves’ disease who are in their first trimester of pregnancy.

In the May 2009 alert, the agency said it was continuing to monitor the serious reported adverse events regarding propylthiouracil.   The FDA also indicated that it was working to make changes to the propylthiouracil prescribing information, particularly for use in pediatric patients.

Propylthiouracil and Children

According to an article published in the April 2009 issue of the New England Journal of Medicine (NEJM), there were more than 9000 prescriptions written for the pediatric use of propylthiouracil in the U.S in 2007. Of the 4000 children with Graves’ disease treated in the U.S. annually, 40 percent are routinely treated with propylthiouracil. 

That NEJM article noted that based on data from the FDA, as well as data presented at a 2008 workshop discussing the safety of the use of the drug in children, routine liver function surveillance has not been effective in measuring the risk of propylthiouracil- induced liver failure.   The authors of the article also noted that the number of pediatric patients who have suffered reversible liver injury as a result of propylthiouracil may be as high as ten times the number of those with irreversible damage.

Finally, the authors pointed out that there is no good plan for managing the risk of hepatoxicity in children other than not using propylthiouracil. They concluded that methimazole, rather than propylthiouracil, should be the first line of therapy for children.

Propylthiouracil Liver Injury Lawsuit Consultation

The liver injuries caused by propylthiouracil are extremely painful and traumatic, especially when they occur in children. The propylthiouracil liver injury lawyers at our firm are working to do everything legally possible to make sure victims of this dangerous drug receive the justice they deserve.

If you or someone you love has used propylthiouracil and suffered liver damage as a result, you may be eligible to file a propylthiouracil lawsuit.    Please fill out our online form or call 1 800 LAW INFO (1-800-529-4636) as soon as possible to discuss your case with one of our propylthiouracil liver injury lawyers.