Changes were made to boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert and medication guide.
The following drugs had modifications to the boxed warnings, contraindications and warnings sections:
- 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)
To view a listing of drug names and safety labeling sections revised, click here. Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
Related Articles on Medication Safety:
CMS Issues Revised ’30-Minute Rule’ on Administration of Medication
Patient Education Tool: 10 Tips to Prevent Accidental Medicine Overdose
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