FDA orders label revision on prostate cancer drugs
FDA orders label revision on prostate cancer drugs
The U.S. Federal and Drug Administration (FDA) on Wednesday ordered makers of prostate cancer drugs to revise medication labels to state a small increased risk of diabetes, heart issues, and even death for patients who take gonadotropin-releasing hormone (GnRH) agonists.
Affected brands include Sanofi’s Eligard, Abbott’s Lupron, and AstraZeneca’s Zoladex. Other drugs available in the market are Watson Pharmaceutical’s Trelstar, Pfizer’s Synarel, and Endo Pharmaceuticals Holdings Inc.’s Vantas.
The drugs limit the amount of testosterone which is a hormone that accelerates malignancy of the prostate gland. The FDA-approved drugs are used in androgen deprivation therapy, a medical technique used to alleviate symptoms of prostate cancer in advanced stage.
The regulatory agency said that while the risk appeared to be low, blood sugar levels or signs of a heart condition should be monitored constantly in patients who receive the drugs.
Physicians should also gauge the risk for heart disease and diabetes before starting treatment, the FDA advised.
About 217,000 new cases of prostate cancer, the second most common cancer in the United States, are recorded each year with roughly 32,000 predicted to die from the disease, health officials say.
A letter written by physicians which was published in the journal Circulation said that androgen deprivation therapy increases the likelihood of cardiac arrest and urged further research to clearly establish the safety of existing drugs.
The FDA announced in May that it was analyzing the results of six studies that showed a small increased risk of heart problems and diabetes in men who underwent androgen deprivation treatment using the drugs in question compared with other treatment strategies.
Posted by
George Daniels
on Thursday October 21 2010, 8:56 AM EST.
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Filed under Featured News, Health.
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