On June 4, the U.S. Food and Drug Administration issued a warning to healthcare professionals associating the risk of liver damage and failure with the use of the anti-thyroid drug propylthiouracil. The drug is prescribed for the treatment of Graves’ disease, an autoimmune disorder that leads to overactivity of the thyroid gland. The FDA’s notification linked the use of propylthiouracil to serious liver injury, including liver failure and death, in both adult and pediatric patients.
“After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves’ disease, methimazole,” said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research, in the report. “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 after initiating therapy.”
The FDA discussed these findings on April 19, 2009 with the American Thyroid Association (ATA) at a public workshop on propylthiouracil-related liver toxicity in Washington, D.C. According to the FDA, a total of 32 cases of serious liver injury associated with the use of propylthiouracil were reported to the FDA’s Adverse Event Reporting System, from when the system was established in 1969 through October 2008. Of the 22 adult cases, the FDA identified 12 deaths and five liver transplants. Of the 10 pediatric cases, there was one death and six reports of liver transplant. In contrast, only five cases of serious liver injury were identified for methimazole, which was approved for marketing in 1950. All five cases were in adult patients, and three resulted in death.
The report did not definitively conclude that there was a causal relationship between propylthiouracil and liver toxicity, nor did it advise healthcare professionals to stop prescribing the product. However, the FDA did advise caution in prescribing the drug, and that each case should be examined individually. For example, because a rare birth defect has been reported with methimazole and not with propylthiouracil, propylthiouracil may be more appropriate for patients with Graves’ disease who are in the first trimester of pregnancy, the report said.
I am pleased that the FDA has brought this issue to the attention of the ATA and issued an official public warning on its website. However, as a Missouri dangerous drug attorney, I must stress that these are only the first steps of many that should be taken to protect patients from the potential negative effects of this drug. Drug companies bear a great responsibility to take the initiative in keeping consumers current on the risks of the products they sell. This means proper labeling, warnings and marketing that properly reflects the risk entailed in using their product. If they fail to do those things, they can be held legally responsible for any injuries that result, through a pharmaceutical injury lawsuit.
The FDA said it is continuing to monitor these serious reported adverse events, and is working to make changes to the propylthiouracil prescribing information, particularly for use in pediatric patients. It also said that it intends to update its information on this issue when additional information or analyses become available. In the meantime, FDA says, adverse reactions or quality problems experienced with use of the propylthiouracil may be reported to the FDA’s MedWatch Adverse Event Reporting program. Their contact information is available online.
Speaking as a Missouri dangerous drug lawyer, I feel it is especially important to address injuries caused by drugs, including those in generic circulation, as soon as possible. Since this particular medication has been marketed for quite some time — since 1947, according to the FDA — millions of Americans could have suffered these adverse effects already. It is important for those people to know what their rights are. That’s why, even if there already is an existing class action suit against a particular drug that may have harmed you, you should contact Carey, Danis & Lowe immediately for a free, confidential consultation. The personalized attention you receive will help you to determine your specific rights and any potential case you may have.
Based in St. Louis, Carey, Danis & Lowe is a national law firm that specializes in representing people who have been injured by, or lost a loved one to, dangerous prescription drugs. Our Missouri defective drug attorneys represent people in the Midwest and across the United States. To set up an appointment with an experienced defective prescription drug attorney, please contact us today through our website, or call us toll-free at 1-877-678-3400.
