The FDA issued a warning on June 4, 2009 regarding use of the medication Propylthiouracil (PTU). This medication is used to treat thyroid disorders, including Grave’s disease. It has been on the market since 1947. Despite its longevity, the FDA has described adverse affects linked to use of the drug that are severe and have proven to be fatal.
The FDA cites its adverse effect reporting system which is showing data that there is an increased risk of serious liver damage (hepatoxicity) with PTU when compared to another drug used for the same treatment, methimazole. Both drugs are indicated for the treatment of hyperthyroidism; however the FDA has found that the threat of liver damage is much higher with PTU.
The agency cites 32 cases of liver damage attributed to propylthiouracil and warns that the medication perhaps has an elevated adverse impact on patients who are juveniles. The warning put out by the agency notes that,”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. Propylthiouracil 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 alert was addressed to endocrine health care professionals and pediatricians. While the drug has been in circulation for decades, it seems that improved data collection tools used by the FDA have resulted in establishment of a pattern of adverse reaction that has gone unnoticed to date.
If you have developed liver problems as the result of treatment for thyroid malfunction or Grave’s disease, contact an experienced attorney familiar with medications that cause serious damage. Contact us today by filling out the brief Free Case Evaluation Form included on this page.