US FDA requires new warning on GnRH agonist labels

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

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Reactions 30 Oct 2010 No. 13250114-9954/10/1325-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved