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The MedWatch November 2011 Safety Labeling Changes posting includes 48 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/ucm282966.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:
Cerebyx (fosphenytoin sodium)
Dilantin (phenytoin sodium, USP)
Dilantin (phenytoin)
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release)
Mytelase (ambenonium chloride)
Onglyza (saxagliptin)
Amturnide (aliskiren/amlodipine/hydrochlorothiazide)
Combivir (lamivudine/zidovudine)
Emtriva (emtricitabine)
Epivir (lamivudine)
Epzicom (abacavir sulfate and lamivudine)
Isentress (raltegravir potassium)
Lioresal Intrathecal (baclofen injection)
Methotrexate Sodium for Injection
Retrovir (zidovudine)
Tekamlo (aliskiren/amlodipine)
Toviaz (fesoterodine fumarate)
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide)
Trizivir (abacavir sulfate, lamivudine, and zidovudine)
Twynsta (telmisartan/amlodipine)
VFEND (voriconazole)
Videx (didanosine)
Videx EC (didanosine, USP)
Vimovo (naproxen/esomeprazole magnesium)
Viread (tenofovir disoproxil fumarate)
Zerit (stavudine)
Ziagen (abacavir sulfate)
Zyflo CR (zileuton)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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