FDA to review Abbott’s Lupron, other drugs

Posted May 3, 2010 at 11:59 a.m.

Dow Jones Newswires | The U.S. Food and Drug Administration is conducting a safety review of
hormone-therapy drugs that are used to treat prostate cancer to see if
the treatments increase the risk of heart attacks, strokes and diabetes.

The drugs, which fall into a class of products known as
gonadotropin-releasing hormone agonists, are sold under brand names that
include Abbott Laboratories’ Lupron, AstraZeneca PLC’s Zoladex and
Sanofi Aventis SA’s Eligard. The products are designed to lower levels
of male hormones, which can shrink prostate tumors and slow the growth
of prostate cancer.


The FDA said Monday it was reviewing data from several published studies that involved patients undergoing hormone therapy for prostate cancer compared to patients who weren’t on hormone therapy.

The agency said six studies showed a “small increased risk of diabetes and/or cardiovascular disease in patients” undergoing hormone treatment.

“However, these studies have design limitations that make it difficult to confirm a cause-and-effect relationship,” the agency said in a statement on its website.

The FDA also said it hasn’t reached a conclusion about whether the products actually increase the risk of diabetes and cardiovascular disease in patients.

The FDA said doctors should be aware of the potential safety risks and monitor their patients for the development of diabetes and cardiovascular disease. The agency said patients currently on hormone therapy should continue to stay on treatment unless they are told to stop by their doctors.

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