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November 2011 Medication Label Changes

Last month brought changes to forty-eight (48) medical product labels (holding steady with 48 changes in October), 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:

Cerebyx (fosphenytoin sodium)
Dilantin (phenytoin sodium, USP)
Dilantin (phenytoin)
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release)
Mytelase (ambenonium chloride)
Onglyza (saxagliptin)
Amturnide (aliskiren/amlodipine/hydrochlorothiazide)
Combivir (lamivudine/zidovudine)
Emtriva (emtricitabine)
Epivir (lamivudine)
Epzicom (abacavir sulfate and lamivudine)
Isentress (raltegravir potassium)
Lioresal Intrathecal (baclofen injection)
Methotrexate Sodium for Injection
Retrovir (zidovudine)
Tekamlo (aliskiren/amlodipine)
Toviaz (fesoterodine fumarate)
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide)
Trizivir (abacavir sulfate, lamivudine, and zidovudine)
Twynsta (telmisartan/amlodipine)
VFEND (voriconazole)
Videx (didanosine)
Videx EC (didanosine, USP)
Vimovo (naproxen/esomeprazole magnesium)
Viread (tenofovir disoproxil fumarate)
Zerit (stavudine)
Ziagen (abacavir sulfate)
Zyflo CR (zileuton)

  • October 2011 Medication Label Changes
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