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.
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