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FDA posts safety labeling changes for 32 products


Thirty-two products recently have had label changes to the boxed warnings, contraindications, and warnings sections, according to the FDA.

Thirty-two products recently have had label changes to the boxed warnings, contraindications, and warnings sections, according to FDA.

The FDA MedWatch July 2011 Safety Labeling Changes posting included the following products:     
Epogen/Procrit (epoetin alfa) and Aranesp (darbepoetin alfa)    
Dostinex (cabergoline) Tablets
Nitrostat (nitroglycerin, USP) Sublingual Tablets
Paxil (paroxetine HCl) tablets, oral solution, and Paxil CR tablets
Ranexa (Ranolazine) Extended-Release Tablets
Rotavirus Vaccine, Live, Oral, Pentavalent (RotaTeq)
Arava (leflunomide) Tablets  
Bentyl (dicyclomine hydrochloride, USP) Capsules/Tablets, Oral Syrup, Injection             
Chantix (varenicline) Tablets    
Flomax (tamsulosin hydrochloride) Capsules
Gilenya (fingolimod) capsules 0.5 mg
Kenalog-10 (triamcinolone acetonide) Injection, Kenalog-40 (triamcinolone acetonide) Injection
Micardis (telmisartan) Tablets
Prograf (tacrolimus) Capsules, Injection
Seroquel (quetiapine fumarate) Tablets, Seroquel (quetiapine fumarate) XR
Tev-Tropin (somatropin [rDNA origin]) for injection
Truvada (emtricitabine/tenofovir disoproxil fumarate) tablets
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 the patient 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 revised safety labeling sections go to:


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