Safety Review of GnRH Agonists and possible increased risk of diabetes and certain cardiovascular diseases

7/3/2010
 

The Saudi Food and Drug Authority (SFDA) is evaluating whether Gonadotropin-Releasing Hormone (GnRH) Agonists may increase the risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer.
GnRH agonists - sold under the brand names Leuprolide Acetate (Lupron®), Goserelin Acetate (Zoladex®), Triptorelin (Decapeptyl®)- are drugs that lower male hormones, which has the effect of shrinking prostate tumors or slowing the growth of prostate cancer. This therapy is known as Androgen Deprivation Therapy or ADT.
SFDA's review is ongoing. The Authority has not made any conclusions about GnRH agonists and whether they increase the risk of diabetes and cardiovascular disease in patients receiving these medications for prostate cancer. At this time, SFDA recommends that:
• Healthcare 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 cardiovascular disease.
• Health care professionals should manage cardiovascular risk factors for patients, such as smoking and increases in blood pressure, cholesterol, blood sugar, and weight, according to current clinical practice.
• Patients should not stop their treatment with GnRH agonists unless told to do so by their healthcare professional.
Report Adverse Drug Reactions to the SFDA:

The SFDA urges both healthcare professionals and patients to report side effects or product quality issues to the SFDA either online, by regular mail or by fax, using the following contact information :

National Pharmacovigilance Center (NPC)
Saudi Food and Drug Authority-Drug sector
3292 Northern Ring Road
Al Nafal District
Riyadh 13312 – 6288
Kingdom of Saudi Arabia
Email : NPC.Drug@sfda.gov.sa
Website: www.sfda.gov.sa/NPC