FDA: Safety Labeling Changes Made to Prescribing Information for 48 Products in November

The U.S. Food and Drug Administration has published safety labeling changes made prescribing information for 48 products in November.


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

11 Strategies to Address Physician and Staff Resistance to Complying With Infection Control Guidelines

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Webinars

Featured Whitepapers

Featured Podcast