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The MedWatch July 2011 Safety Labeling Changes posting includes 32 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm266122.htm
Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:
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
Tell us how we are doing:
http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=08_11_2011_1515&cpp[type]=S
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