Propylthiouracil Side Effects Injury Lawsuits. Propylthiouracil, a drug used to treat an overactive thyroid or Graves’ disease, has been associated with severe liver injuries in both adults and children. In April 2010, the U.S. Food & Drug Administration (FDA) decided that because the liver injury risk from propylthiouracil was so great, a boxed warning should be added to the drug’s label. Some propylthiouracil liver injury victims have required liver transplants, and others have died because of this medication.Our propylthiouracil liver injury lawyers are currently investigating potential lawsuits on behalf of people injured by this drug. We know that no amount of money can truly make up for the suffering caused by propylthiouracil liver injuries. But fair compensation for medical bills, lost wages, and pain and suffering can help you put your life back on track.
The pain and trauma caused by propylthiouracil liver injuries is immeasurable. This is especially true when they occur in children. If you or someone you love suffered liver damage as a result of propylthiouracil, you may be entitled to compensation. To arrange for a free case evaluation, please contact one of our propylthiouracil liver injury lawyers as soon as possible.
FDA Boxed Warning on Propylthiouracil
Propylthiouracil was first approved in 1947. It is a second line treatment for overactive thyroid and Graves’ disease for patients who are allergic to or intolerant of methimazole. It is also used to treat overactive thyroid and Graves’ disease in pregnant women, as methimazole has been associated with rare cases of birth defects when used in pregnancy.
According to the FDA, from 1969 to June 2009, it has received reports of 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.
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.
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 compared to methimazole in both adult and pediatric patients.
The new boxed warning states that for patients being started on treatment for hyperthyroidism it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole, radioactive iodine or surgery. In addition, due to the occurrence of birth defects that have been observed with the use of methimazole during the first trimester of pregnancy, propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy.
To help patients understand the known benefits and potential risks of propylthiouracil, as part of a Risk Evaluation and Mitigation Strategy (REMS), the FDA is also requiring that a Medication Guide be given to every patient filling a prescription for propylthiouracil.
Finally, the FDA is also advising healthcare providers that propylthiouracil is not recommended for use in pediatric patients, except in rare instances in which other alternative treatments are not appropriate.
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.