FDA formalizes warning of cardivascular risks for LHRH agonists
Posted Oct 21 2010 12:00am
According to a media release from the U.S. Food and Drug Administration (FDA) yesterday, the agency has asked manufacturers of the class of drugs known as luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists to include warnings about risk for cardiovascular disease and diabetes in product labeling for these drugs.
The LHRH agonists are extensively used in management of prostate cancer, most commonly in men receiving radiation therapy for localized or locally advanced disease and in men with more advanced forms of prostate cancer who have not responded to treatment for localized disease or who have relapsed after such treatment. However, they are also used alone (and perhaps less appropriately) as first-line therapy for some men; in these types of patients, the relatively benefits of LHRH therapy should be very carefully weighed against the risks for cardiovascular, metabolic, and other complications.
The most commonly used drugs to which this warning will apply are:
Leuprolide acetate (Lupron, Eligard, Viadur)
Goserelin acetate (Zoladex)
Triptorelin pamoate (Trelstar)
Histrelin (Vantas)
This new “class warning” reflects findings from an FDA investigation initiated earlier this year and discussed on this web site which showed a relatively small but significant increase in risk for diabetes, heart attack, stroke, and sudden death associated with use of these and similar agents.
According to a media release from the U.S. Food and Drug Administration (FDA) yesterday, the agency has asked manufacturers of the class of drugs known as luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists to include warnings about risk for cardiovascular disease and diabetes in product labeling for these drugs.
The LHRH agonists are extensively used in management of prostate cancer, most commonly in men receiving radiation therapy for localized or locally advanced disease and in men with more advanced forms of prostate cancer who have not responded to treatment for localized disease or who have relapsed after such treatment. However, they are also used alone (and perhaps less appropriately) as first-line therapy for some men; in these types of patients, the relatively benefits of LHRH therapy should be very carefully weighed against the risks for cardiovascular, metabolic, and other complications.
The most commonly used drugs to which this warning will apply are:
This new “class warning” reflects findings from an FDA investigation initiated earlier this year and discussed on this web site which showed a relatively small but significant increase in risk for diabetes, heart attack, stroke, and sudden death associated with use of these and similar agents.