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January 2012 Medication Label Changes

Last month brought changes to sixty-three (63) medical product labels (up from 40 changes in December), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will view the detailed summary which will identify the safety labeling section and revised subsection, and a brief summary of the new or modified safety information.

The following medications have been affected:

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 (benazepril)
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)