Home > FDA MedWatch > FDA MedWatch – November 2011 Safety Labeling Changes

FDA MedWatch – November 2011 Safety Labeling Changes

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:


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)

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