Thursday, October 28, 2010

FDA Asks for Tougher Warnings on GnRH Agonists

The FDA has asked manufacturers of gonadotropin-releasing hormone (GnRH) agonists -- a class of drugs used primarily to treat prostate cancer -- to add new warnings about the potential risk for heart disease and diabetes.

Earlier this year the FDA recommended that the risks of GnRH agonists be carefully considered before beginning treatment, but Wednesday's announcement solidifies the FDA's growing concerns with GnRH agonists.
Earlier this year, the American Heart Association, the American Urological Association, and the American Cancer Society issued a joint advisory warning of the increased risks of diabetes, myocardial infarction, stroke, and sudden death among men who use androgen deprivation therapy (ADT) to treat prostate cancer. GnRH is the most common form of ADT.

The groups did not offer specific guidelines for clinicians on when to employ ADT therapy or when to avoid it.

Clinical trials have shown that ADT increases body weight, decreases lean mass and increases fat mass, reduces insulin sensitivity, and triggers or worsens dyslipidemia.