Published on:

October 2012 Medication Label Changes

Last month brought changes to fifty-eight (58) medical product labels(down slightly from 60 changes in September), 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 be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

Aciphex (rabeprazole sodium)
Actemra (tocilizumab)
Advicor (niacin ER/lovastatin)
Alimta (pemetrexed for injection)
Altoprev (lovastatin)
Anafranil (clomipramine)
Avalide (irbesartan/hydrochlorothiazide)
Caduet (amlodipine/atorvastatin)
Cimzia (certolizumab pegol)
Clomid (clomiphene citrate)
Combigan (brimonidine tartrate/timolol maleate)
Crestor (rosuvastatin calcium)
Cymbalta (duloxetine hydrochloride)
Diovan (valsartan) and Diovan HCT (valsartan/hydrochlorothiazide)
Edarbi (azilsartan medoxomil)
Edarbyclor (azilsartan medoxomil/chlorthalidone)
Fenoglide (fenofibrate)
Gelnique (oxybutynin chloride)
Juvisync (sitagliptin/simvastatin)
Lescol XL (fluvastatin sodium)
Letairis (ambrisentan)
Lipitor (atorvastatin calcium)
Livalo (pitavastatin)
Lotrel (amlodipine besylate and benazepril hydrochloride)
Mevacor (lovastatin)
Micardis (telmisartan) and Micardis HCT (telmisartan/hydrochlorothiazide)
Nexium I.V. (esomeprazole sodium)
Nexium (esomeprazole magnesium)
Oxytrol (oxybutynin)
Pravachol (pravastatin sodium)
Prilosec (omeprazole)
Protonix (pantoprazole sodium)
Protonix I.V. (pantoprazole sodium)
Pamelor (nortriptyline HCl)
Remeron and Remeron SolTab (mirtazapine)
Simcor (Niacin ER/Simvastatin)
Tofranil-PM (imipramine pamoate)
Topamax (Topiramate)
Tracleer (Bosentan)
Twynsta (Telmisartan/Amlodipine)
Vimovo (naproxen/esomeprazole magnesium)
Vytorin (ezetimibe/simvastatin)
Zocor (simvastatin)

Posted in:
Published on:
Updated: