New FDA warnings about Lupron and related meds

FDA Requiring GnRH Agonists To Carry Warnings About Potential Risk For Heart Disease, Diabetes.

The Wall Street Journal /Dow Jones Newswire (10/21, Dooren) reports that to shrink prostate tumors, the medical community relies on a group of products that reduce male hormone levels, but these gonadotropin-releasing hormone (GnRH) agonists may also increase the risk of diabetes and cardiovascular problems. Thus, the FDA is now requiring the drugs, marketed under generic and brand names like Zoladex (goserelin), Lupron (leuprolide), Trelstar (triptorelin), Vantas (histrelin), and Synarel (nafarelin), carry labels that highlight the potential risks.

In February, "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," MedPage Today (10/20, Walker) reported. "GnRH is the most common form of ADT. However, the groups did not offer specific guidelines for clinicians on when to employ ADT therapy or when to avoid it."

Thus, the FDA stepped in May and "announced...that it was reviewing the" GnRH agonists, HealthDay (10/20, Reinberg) reported. "Speaking after the FDA's announcement earlier this spring," Dr. Nelson Neal Stone, of the Mount Sinai School of Medicine, "said studies have shown that men with advanced prostate cancer who take hormone therapy face a twofold increased risk of developing metabolic syndrome, a cluster of symptoms tied to the development of heart disease." And, "once patients understand that, Stone hopes they will be motivated to watch their diet and exercise." For the time being, however, "men should not stop taking their hormone therapy, but do everything they can to reduce their risk of developing cardiovascular disease and diabetes with lifestyle changes, he said."

Still, the "relationship between heart disease risk, diabetes, and androgen deprivation therapy has not been without controversy," Medscape (10/20, Mulcahy) pointed out. "A medical oncologist specializing in prostate cancer treatment recently defended the safety of the therapeutic approach in an interview with Medscape Medical News." Mark Scholz, MD, of the California-based Prostate Cancer Research Institute, said, "There is no convincing evidence that hormone blockade shortens life or causes excess heart attacks if weight gain is attended to and blood sugar levels are kept in check."

Nevertheless, even though "all of the drugs will stay on the market," they "will be required to carry new label warnings," WebMD (10/20, DeNoon) reported. "The risk that the drugs will trigger diabetes or heart disease/stroke appears small, the FDA says," but again, "recent studies suggest that doctors should monitor blood sugar levels and watch for signs of heart disease in men taking these drugs." Reuters (10/21, Richwine) also covers the story.

From the AUA

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