FDA March 2012 Safety Labeling Changes

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The MedWatch March 2012 Safety Labeling Changes posting includes 39 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm299284.htm

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Atacand HCT (candesartan cilextetil/hydrochlorothiazide)
Benicar (olmesartan medoxomil)
Sporanox (itraconazole)
Twynsta (telmisartan/amlodipine)
Zestoretic (lisinopril/hydrochlorothiazide)
Zestril (lisinopril)
Benlysta (belimumab)
Celexa (citalopram hydrobromide)
Enablex (darifenacin)
Incivek (telaprevir)
Janumet (sitagliptin and metformin fixed-dose combination)
Januvia (sitagliptin)
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release)
Lidocaine in 5% Dextrose Injection
Magnevist (brand of gadopentetate dimeglumine)
Revlimid (lenalidomide)
Reyataz (atazanavir sulfate)
Treximet (sumatriptan and naproxen sodium)
Votrient (pazopanib)
Zometa (zoledronic acid)
Zmax (azithromycin extended release)

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