FDA warns of prostate cancer drug risks

WASHINGTON (Reuters) - Hormone treatments for prostate cancer need new warnings about a small increased risk of diabetes and heart problems including sudden death, U.S. health officials said on Wednesday.

The medications include Abbott Laboratories Inc's Lupron, AstraZeneca Plc's Zoladex and Sanofi-Aventis SA's Eligard.

The drugs, known as gonadotropin-releasing hormone (GnRH) agonists, are used to suppress the production of testosterone, a hormone that helps fuel prostate cancer growth. The drugs are approved to relieve symptoms of advanced prostate cancer in a treatment known as androgen deprivation therapy.

The Food and Drug Administration said the risk of diabetes and heart disease in men treated with the drugs appeared to be low, but that patients should be regularly monitored for increased blood sugar or possible signs of heart damage.

Doctors also should evaluate a patient's risk for diabetes and heart disease before starting treatment and weigh potential side effects versus benefits, the FDA said.

Other GnRH drugs include Watson Pharmaceuticals Inc's Trelstar, Endo Pharmaceuticals Holdings Inc's Vantas, and Pfizer Inc's Synarel. Several generic versions also are sold.

Prostate cancer is the second most common cancer among U.S. men. More than 217,000 new cases are expected to be diagnosed in the United States this year and about 32,000 men will die from the disease, according to government estimates.

Hormone therapies are a mainstay of treatment for advanced prostate cancer when other therapies fail, Abbott spokeswoman Elizabeth Hoff said.

Diabetes, increases in blood sugar and heart problems already are mentioned on Lupron's label, and the company will comply with the FDA request to add the new warning, she said.

The agency asked manufacturers to put the information in a section of the prescribing instructions called "warnings and precautions."

Sanofi spokeswoman Emmy Tsui said the company was "committed to the safe and effective use of Eligard" and was reviewing the FDA request. Officials at other makers had no immediate comment or could not immediately be reached.

In February, various doctors' groups wrote in the medical journal Circulation that they felt androgen deprivation treatment was likely to raise the risk of heart attack. They called for studies to determine the level of risk.

The FDA said in May it was reviewing six studies that showed a small increased risk of diabetes or heart disease in patients treated with the drugs when compared with other prostate cancer therapies.

(Reporting by Lisa Richwine; editing by Carol Bishopric)