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FDA conducting safety review of GnRH agonists

Preliminary data suggest an increased risk for diabetes, CV diseases.

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The FDA announced today that it is conducting an ongoing safety review of gonadotropin-releasing hormone agonists, primarily used for androgen deprivation therapy in men with prostate cancer, due to preliminary evidence that points to an increased risk for diabetes, MI, stroke and sudden death in men who use the drugs.

“While our review of these prostate cancer treatments is ongoing and there are some limitations to the data, [the] FDA believes it is important to tell patients and health care professionals that there may be an increased risk for serious side effects,” said Robert Justice, MD, director of the division of drug oncology products in the FDA’s Center for Drug Evaluation and Research.

Medications in the GnRH class are Lupron (Abbott), Zoladex (AstraZeneca), Trelstar (Watson), Viadur (Bayer), Vantas (Endo), Eligard (Sanofi-Aventis) and Synarel (Pfizer), as well as several generic drugs.

Although the FDA has not yet made any final conclusions about GnRH agonists, it issued some recommendations based on its initial findings:

• Health care professionals should be aware of these potential safety issues and carefully weigh the benefits and risks of GnRH agonists when determining treatment.
• Patients receiving GnRH agonists should be monitored for development of diabetes and CV disease.
• Health care professionals should manage CV risk factors for patients, such as smoking and increases in blood pressure, cholesterol, blood glucose and weight, according to current clinical practice.
• Patients should not stop their treatment with GnRH agonists unless told to do so by their health care professional.

These recommendations are consistent with those issued jointly by the American Heart Association, American Cancer Society and American Urological Association in a Science Advisory published in Circulation in February.

In addition to prostate cancer, GnRH agonists are also used to treat pain associated with endometriosis, for the preoperative improvement of anemia caused by uterine fibroids, as palliative treatment for advanced breast cancer, and in children to treat central precocious puberty.

Additional information can be found on the FDA’s website.

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