Prostate Cancer Drugs Side Effects Being Reviewed by FDA

Federal drug reviewers are investigating a class of prostate cancer drugs for potential health risks that could include diabetes and death. 

The FDA announced this week that it has begun a safety review of Gonadotropin-Releasing Hormone (GnRH) agonists, a class of medications used in the treatment of prostate cancer. The GnRH safety review was sparked by studies and reports indicating that side effects of the drugs can increase the risk of diabetes, heart attack, stroke and sudden death in men.

GnRH’s suppress the production of testosterone, limiting the ability of prostate cancer to grow. The class of drugs includes Sanofi-Aventis’s Eligard, Abbott Laboratories’ Lupron, and Pfizer’s Synarel, among other brand names, as well as generic products.

The FDA is recommending that health care professionals be made aware of the potential risks and carefully weigh those risks before prescribing the drugs. The agency is also recommending that patients prescribed a GnRH be monitored for diabetes and cardiovascular disease, and that cardiovascular risk factors, such as smoking and high blood pressure, be controlled while taking the medication. The FDA also warned patients not to stop treatment with GnRH’s unless instructed by their health care provider.

The FDA says that the review is ongoing, and that it has not made any conclusions regarding the safety of GnRHs. The drugs are also often used to treat women suffering from pain caused by endometriosis, and to treat anemia and breast cancer. It is also used in children to treat central precocious puberty. However, these uses have not been approved by FDA.

The agency says it will release more data on the safety review as the review continues.