January 2012 Safety Labeling Changes posting includes 63 products

The MedWatch January 2012 Safety Labeling Changes posting includes 63 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.

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

Accupril (quinapril hydrochloride)
Accuretic (quinapril HCl/ hydrochlorothiazide)
Altace (ramipril)
Avalide (irbesartan/hydrochlorothiazide)
Avapro (irbesartan)
Azor (amlodipine/olmesartan)
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide)
Diovan (valsartan)
Diovan HCT (valsartan/hydrochlorothiazide)
Exforge (amlodipine/valsartan)
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide)
Lotensin (benazapril)
Lotensin HCT (benazapril/hydrochlorothiazide)
Lotrel (amlodipine besylate and benazepril hydrochloride)
Mavik (trandolapril)
Micardis (telmisartan)
Micardis HCT (telmisartan/hydrochlorothiazide)
Tarka (trandolapril/verapamil hydrochloride)
Teveten (eprosartan mesylate)
Teveten HCT (eprosartan mesylate/hydrochlorothiazide)
Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide)
Univasc (moexipril hydrochloride)
Uniretic (moexipril hydrochloride/hydrochlorothiazide)

Ceftriaxone for Injection and Dextrose Injection in Duplex Container
Evoclin (clindamycin phosphate)
Mavik (trandolapril)
Micardis (telmisartan)
Micardis HCT (telmisartan/hydrochlorothiazide)
Micardis HCT (telmisartan/hydrochlorothiazide)
Twynsta (telmisartan/amlodipine)
Xenical (orlistat)
Chantix (varenicline)
Erbitux (cetuximab)
Fanapt (iloperidone)
Fazaclo (clozapine)
Gralise (gabapentin)
Morphine Sulfate Oral Solution,
Morphine Sulfate Tablets
Nexium (esomeprazole sodium)
Nexium (esomeprazole magnesium)
Performist (formoterol fumarate)
Pradaxa (dabigatran etexilate mesylate)
Vimovo (naproxen/esomeprazole magnesium)
Vytorin (ezetimibe/simvastatin)
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