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FDA to Require Warnings About Hormone Therapy Prostate Cancer Drugs

The Food and Drug Administration has announced that it will require warnings to be added to hormone therapy prostate cancer drugs.  The drugs are part of a category of drugs called gonadotropin-releasing hormone agonists.  Some of the most common brands in this category of drugs include Abbott Laboratories’ Lupron, Astrazeneca’s  Zoladex, and Pfizer’s Synarel.

These hormone therapy drugs are designed to treat prostate cancer by lowering the levels of male hormones.  This can help shrink the prostate tumor, and slow down the growth of the cancer.  Besides these brand name medications, several other forms of gonadotropin-releasing hormone agonists are sold under generic names.

The Food and Drug Administration has been reviewing data this year involving patients who used the hormone therapy prostate cancer drugs, compared to patients who did not take the therapy.  According to the Food and Drug Administration, at least six studies indicated a small increased risk of developing diabetes or cardiovascular disease among patients who took the hormone therapy for treatment of prostate cancer.

These concerns about the increased risk of cardiovascular disease and diabetes have been around for a while.  Earlier this year, the American Cancer Society, the American Heart Association, and the American Urological Association issued an advisory warning that the hormone therapy could possibly increase the risk of cardiac problems.  Those warnings came after doctors from these organizations reviewed patient data.  After those warnings from these agencies, the Food and Drug Administration recommended that doctors monitor patients on the therapy to check for diabetes and cardiovascular disease.  The FDA also recommended that doctors manage cardiovascular risk factors including high blood pressure, diabetes, smoking and obesity.

Several other studies have shown a link between the use of the hormones for the treatment of prostate cancer and an increase in low-density lipoprotein cholesterol, or the bad cholesterol.  This increase in lipoprotein cholesterol can cause blood sugar abnormalities, which can increase the risks of developing diabetes and cardiovascular disease.

The Food and Drug Administration is likely to require that manufacturers of these hormone therapy treatments for prostate cancer require stronger warning labels on their products, cautioning patients about the increased risk of developing cardiovascular disease and diabetes from these products.

Gonadotropin-releasing hormone agonist therapy is also called androgen deprivation therapy.  Other clinical trials on androgen deprivation therapy in the past have linked the drugs to an increase in body weight.  The drugs also decrease lean mass and cause an increase in the fat mass in the body.  The therapy has also been linked to a reduction in insulin sensitivity, and is believed to worsen a person’s dyslipidemia.

The therapy is also being currently used to treat various conditions in females as well as children.  However, there has been no comparative study of any possible risk to these populations from the use of these drugs.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of pharmaceutical liability. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

The Reeves Law Group is not representing any party in the matters discussed in this posting.

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