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Monthly Safety Labeling Changes includes 39 products with revisions to Prescribing Information

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.

This content was written and submitted by the supplier. It has only been modified to comply with this publication’s space and style.


The "Summary Page" provides a listing of drug names and safety labeling sections revised.

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)

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch.

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