Reactions 1325 - 30 Oct 2010 US FDA requires new warning on GnRH agonist labels Following a safety review of the use of gonadotropin- releasing hormone (GnRH) agonists for the palliative treatment of prostate cancer, * the US FDA has notified the manufacturers of these medications that new safety information will be required in the Warnings and Precautions section of the drug labels. The new information will warn of the small, but significantly increased risk of diabetes and/or certain cardiovascular (CV) disorders (myocardial infarction sudden cardiac death and stroke) associated with the use of these medications. Healthcare professionals are advised to monitor blood glucose and/or glycosylated haemoglobin levels periodically in patients receiving GnRH agonists, as well as monitoring patients for signs and symptoms suggestive of the development of CV disorders. Healthcare professionals should also ensure that CV risk factors such as cigarette smoking, high BP, high cholesterol, high blood sugar and overweight are managed according to current clinical practice. * See Reactions 1300 p1; 801140490 FDA. FDA Drug Safety Communication: update to ongoing safety review of GnRH agonists and notification to manufacturers of GnRH agonists to add new safety information to labeling regarding increased risk of diabetes and certain cardiovascular diseases. Internet Document : [2 pages], 20 Oct 2010. Available from: URL: http://www.fda.gov 801140836 1 Reactions 30 Oct 2010 No. 1325 0114-9954/10/1325-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved

US FDA requires new warning on GnRH agonist labels

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Reactions 1325 - 30 Oct 2010

US FDA requires new warning onGnRH agonist labels

Following a safety review of the use of gonadotropin-releasing hormone (GnRH) agonists for the palliativetreatment of prostate cancer,* the US FDA has notifiedthe manufacturers of these medications that new safetyinformation will be required in the Warnings andPrecautions section of the drug labels.

The new information will warn of the small, butsignificantly increased risk of diabetes and/or certaincardiovascular (CV) disorders (myocardial infarctionsudden cardiac death and stroke) associated with theuse of these medications.

Healthcare professionals are advised to monitorblood glucose and/or glycosylated haemoglobin levelsperiodically in patients receiving GnRH agonists, as wellas monitoring patients for signs and symptomssuggestive of the development of CV disorders.Healthcare professionals should also ensure that CV riskfactors such as cigarette smoking, high BP, highcholesterol, high blood sugar and overweight aremanaged according to current clinical practice.* See Reactions 1300 p1; 801140490

FDA. FDA Drug Safety Communication: update to ongoing safety review ofGnRH agonists and notification to manufacturers of GnRH agonists to add newsafety information to labeling regarding increased risk of diabetes and certaincardiovascular diseases. Internet Document : [2 pages], 20 Oct 2010. Availablefrom: URL: http://www.fda.gov 801140836