U.S. reviews diabetes, heart risk with prostate drugs

上一篇 / 下一篇 2010-05-17 10:14:37 / 天气: 晴朗 / 心情: 高兴

U.S. reviews diabetes, heart risk with prostate drugsU.S. reviews diabetes, heart risk with prostate drugsThe FDA is looking at data from published studies to determineConcrete Bladethe risks with commonly used Gonadotropin-Releasing Hormone (GnRH) agonist drugs, the agency said on Monday.

The products include Abbott Laboratories' Lupron, #x AstraZeneca Plc's Zoladex, Watson Pharmaceuticals Inc's Trelstar, Endo Pharmaceuticals Holdings Inc's Vantas, Sanofi-Aventis SA's Eligard and Pfizer Inc's Synarel.

The agency said it has not made any conclusions about GnRH agonists, which suppress the production of testosterone,google优化, a hormone that helps fuel growth of prostate cancer.

Suppressing testosterone has been shown to shrink or slow the growth of prostate cancer. The treatment is known as androgen deprivation therapy.

However, the FDA noted that patients should be monitored for potential onset of diabetes or cardiovascular disease that can cause heart attacks, stroke and sudden cardiac death.

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

"However, these studies have design limitations that make it difficult to confirm a cause-and-effect relationship," an agency statement said.

The studies included limited information about drug exposure, varying definitions for heart disease, missing data on heart disease risk factors and other problems, #x the FDA said.

Patients should not stop taking the drugs unless a doctor tells them to, the FDA advised.

Some GnRH agonists also are prescribed at times to women and children to treat other conditions. The FDA said there were no known comparable studies that evaluated the risk of diabetes and heart disease in those groups.

Sanofi is evaluating cases of elevated insulin and blood clots "to determine whether labeling changes #x or other actions are required," company spokeswoman Emmy Tsui said.

The company "remains confident in the overall safety profile of Eligard based on clinical trials and post-marketing surveillance," company spokeswoman Emmy Tsui said.Concrete Blade相关的主题文章：

U.S. reviews diabetes, heart risk with prostate drugs

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