Propylthiouracil Liver Failure Lawsuit

The following information on a Propylthiouracil liver failure lawsuit is provided by Pritzker Olsen law firm. Our lawyers have appeared on CBS News, Fox News and local television stations discussing product liability litigation and product safety. To contact an attorney at Pritzker Olsen about a medication lawsuit, call 1-888-377-8900 (TOLL FREE) or submit our online form for a free consultation.

The United States Food and Drug Administration (FDA) has added a Boxed Warning to the label for propylthiouracil, a drug used to treat hyperthyroidism (overactive thyroid), to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients using propylthiouracil.

The FDA has identified 34 cases of severe liver injury associated with propylthiouracil. Twenty-three cases were in adult patients and 11 were in pediatric patients. Of the 23 adult cases, 13 deaths and five liver transplants were reported. Among the 11 pediatric cases, two cases resulted in death and seven patients required a liver transplant; one patient died while on the transplant list. FDA identified five cases of severe liver injury reported with methimazole. All five cases were in adult patients and three resulted in death. Based on these findings, and a review of the medical literature, the agency concluded that use of propylthiouracil is associated with a higher risk for clinically serious or fatal liver injury.

Additional information for patients from the FDA:

Be aware that severe liver injury has occurred in patients taking propylthiouracil.
Read the Medication Guide when picking up a prescription for propylthiouracil. It will help you understand the potential risks and benefits of this medication.
Contact your healthcare professional if you have fever, loss of appetite, nausea, vomiting, tiredness, itchiness, dark colored urine, or yellowing of your skin or eyes while taking propylthiouracil.
Propylthiouracil may be the treatment of choice during and just before the 1st trimester of pregnancy (weeks 1-12). Talk to your healthcare professional if you are pregnant (or plan to become pregnant) and are taking a medication to treat hyperthyroidism.
Tell your healthcare professional about any medication you are taking or medical conditions you may have before taking propylthiouracil.
Do not stop taking propylthiouracil unless told to do so by your healthcare professional.

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