Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) has issued a warning to endocrine health care professionals, pharmacists and pediatricians about the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil (PTU) in adult and pediatric patients. PTU is a drug used to treat hyperthyroidism, including Graves disease, by decreasing the amount of thyroid hormone produced by the thyroid gland. Hyperthyroidism occurs when the thyroid gland is overactive and produces excess thyroid hormones.

Reports to the FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared to another medication used to treat hyperthyroidism, methimazole (MMI). Twenty-two adult and 10 pediatric cases of serious liver injury associated with PTU have been reported to AERS.

The FDA is asking healthcare professionals to carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. Physicians also should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initial therapy. PTU should not be used in pediatric patients unless the patient is allergic or intolerant to MMI and no other treatment options are available.

The FDA is continuing to monitor cases reported to AERS and working to make changes to the propylthiouracil prescribing information, particularly for use in pediatric patients. The American Thyroid Association also plans to update its treatment guidelines for Graves’ disease in the upcoming months to reflect the warnings.

Source: FDA

This entry was posted on Friday, June 5th, 2009 at 7:00 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.