FDA: Safety Labeling Changes Made to Prescribing Information for 40 Products in December

The U.S. Food and Drug Administration has published safety labeling changes made prescribing information for 40 products in December.


Changes were made to boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package inserts and medication guides.


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The following drugs had modifications to the boxed warnings, contraindications and warnings sections:

  • Multaq (dronedarone hydrochloride) tablets
  • Dilantin-125 (phenytoin) Oral Suspension
  • Norvir (ritonavir) Soft Gel Capsules, Oral Solution and Tablets
  • Relenza (zanamivir) inhalation powder
  • Tyzeka (telbivudine) tablets and oral solution
  • Capoten (captopril) Tablets
  • Danocrine brand of Danazol capsules
  • Desferal (deferoxamine mesylate) for injection
  • Edarbi (azilsartan medoxomil) Tablets
  • Eloxatin (oxaliplatin)  for intravenous use
  • Heparin Sodium Injection
  • Isentress (raltegravir) scored, chewable tablets, film-coated tablet
  • Keppra (levetiracetam) Tablets and oral solution
  • Onglyza (saxagliptin) tablets
  • Ovide (malathion) 0.5% lotion1
  • PegIntron (Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use
  • Plavix (clopidogrel bisulfate) tablets
  • Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating
  • Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension and capsules


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:

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Patient Education Tool: Medication Risks Poster

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