Prostate cancer drugs that can cause heart attack, stroke, diabetes and even sudden death must now carry labels to warn patients of their potential risks, according to a new U.S. Food and Drug Administration rule.

In May, the FDA first announced the drugs’ links to the health problems, saying patients taking gonadotropin-releasing hormone (GnRH) agonists were at a small increased risk for the health complications.

“I think this was long due,” said Dr. David Samadi, vice chair of Urology at Mount Sinai School of Medicine in New York City. “A lot of times the risks [of taking the medication] outweigh the benefit; as more and more patients read about side effects, they will choose surgery over radiation.”

Not only are the drugs bad especially for men with heart problems, but they induce symptoms of “male menopause,” he said, causing depression, fatigue and weight gain. These changes occur naturally as men age and their testosterone drops, but the drugs bring them on sooner, he said.

However, in very serious prostate cancer, the drugs still work wonders, said Dr. Ana Aparicio, an assistant medical oncology professor at the University of Texas’ M.D. Anderson Cancer Center.

“These drugs are extremely effective for treating this disease, and in all do make people feel better,” Aparicio said.

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Most of the committee members voted to leave Avandia on the market but recommended that changes be made in how it is prescribed. Additionally, 12 out of the committee’s 33 members voted to pull Avandia off the market altogether, while only three supported leaving it on the market with its current labeling. Seven voted to add stiffer warnings to the current label, and 10 wanted both stiffer language and restrictions on its use.

A 2007 study, published in the New England Journal of Medicine, linked the drug to a 43 percent higher chance of heart attack as well as in increased risk of stroke and, in some cases, death. After that, federal regulators mandated that GlaxoSmithKline (GSK) add more warnings to the drug’s labeling.

GSK is facing more than 13,000 legal challenges, and has already awarded $60 million to settle some of them. A Philadelphia court will hear the first American cases in October.

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