The FDA announced that it’s reviewing the safety of a class of prostate cancer drugs, following up on data that suggest an increased risk of diabetes and certain heart problems.
The agency is sifting data from published studies of drugs that fight gonadotropin-releasing hormone, used to treat men with prostate cancer. At issue: whether the GnRH agonists carry an increased risk of diabetes or heart trouble compared with other prostate meds. The products involved in the probe are Abbott Laboratories’ Lupron, AstraZeneca’s Zoladex, Watson Pharmaceuticals’ Trelstar, Endo Pharmaceutical Holdings’ Vantas, Sanofi-Aventis’ Eligard and Pfizer’s Synarel.
As the probe proceeds, the agency has advised patients and doctors to watch closely for signs of diabetes and heart disease. “While our review of these prostate cancer treatments is ongoing and there are some limitations to the data, FDA believes it is important to tell patients and healthcare professionals that there may be an increased risk of serious side effects,” said Dr. Robert Justice, director of the oncology drug division in FDA’s Center for Drug Evaluation and Research.
Meanwhile, the FDA released a quarterly list of safety probes, revealing investigations into reports of male breast cancer in patients using various prostate drugs, and liver toxicity in patients on an HIV-prevention regimen. The probes are in early stages yet; the potential safety issues were only just identified last fall.
By Tracy Staton