FDA posts safety label changes for 32 products

FDA has announced changes to the boxed warnings, contraindications, and warnings sections of the labels for 32 products.

The FDA MedWatch July 2011 Safety Labeling Changes posting included the following products:

• Epogen/Procrit (epoetin alfa) and Aranesp (darbepoetin alfa)
• Epogen Dostinex (cabergoline) tablets
• Epogen Nitrostat (nitroglycerin, USP) sublingual tablets
• Epogen Paxil (paroxetine HCl) tablets, oral solution, and CR tablets
• Epogen Ranexa (Ranolazine) Extended-Release tablets
• Epogen Rotavirus Vaccine, Live, Oral, Pentavalent (RotaTeq)
• Epogen Arava (leflunomide) tablets
• Epogen Bentyl (dicyclomine hydrochloride, USP) capsules/tablets, oral syrup, injection
• Epogen Chantix (varenicline) tablets
• Epogen Flomax (tamsulosin hydrochloride) capsules
• Epogen Gilenya (fingolimod) capsules 0.5 mg
• Epogen Kenalog-10 (triamcinolone acetonide) injection, Kenalog-40 (triamcinolone acetonide) injection
• Epogen Micardis (telmisartan) tablets
• Epogen Prograf (tacrolimus) capsules, injection
• Epogen Seroquel (quetiapine fumarate) tablets, Seroquel (quetiapine fumarate) XR
• Epogen Tev-Tropin (somatropin [rDNA origin]) for injection
• Epogen Truvada (emtricitabine/tenofovir disoproxil fumarate) tablets
• Epogen Zegerid OTC (omeprazole 20mg and sodium bicarbonate 1100 mg) capsules

“FDA’s just-released series of updates and/or changes for safety labeling purposes on 32 products primarily catches them up on what has been known for a while in the marketplace,” said Randy Vogenberg, PhD, principal at the Institute for Integrated Healthcare in Sharon, Mass., and executive director of the Biologic Access & Finance program at The Jefferson School of Population Health in Philadelphia.

“Changes to patient information … will better inform patients of potential issues to watch for or report to their clinician or pharmacist,” said Vogenberg, who is the author of Pharmacy Benefits: Management and Benefit Design, published by IFEBP.

For a more detailed listing of drug names and safety labeling sections go to: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm266122.htm.