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:
- Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension
- Evamist (estradiol transdermal spray)
- Selzentry (maraviroc) Tablets
- Demerol (meperidine hydrochloride)
- Oral Hycamtin (topotecan) Capsules
- Premarin (conjugated estrogens tablets, USP)
- Suprenza (phentermine hydrochloride) ODT
- Amturnide (amlodipine/aliskiren/hydrochlorothiazide) Tablets
- Avelox (moxifloxacin hydrochloride) Tablets and IV
- Byetta (exenatide) injection
- Clozaril (clozapine) Tablets
- Ciprofloxacin Tablets
- Ciprofloxacin IV for Inusion Vial
- Ciprofloxacin 0.2 % Solution in 5% Dextrose
- Ciprofloxacin Oral Suspension
- Cipro XR Tablets
- Factive (gemifloxacin mesylate) Tablets
- Gallium Citrate Ga 67 Injection
- Lactated Ringer’s injection in aviva plastic container
- Lactated Ringer’s,
- Lactated Ringer’s and 5% Dextrose
- Sodium Lactate (M/6 sodium lactate) injections in viaflex plastic container
- Levaquin (levofloxacin) Tablets
- Lithium Carbonate 150 mg, 300 mg, and 600 mg capsules
- Lithobid (lithium carbonate) Extended-Release tablets
- Nexavar (sorafenib)
- Noroxin (norfloxacin) Tablets
- OxyContin (oxycodone hydrochloride) Controlled-Release Tablets
- Tasigna (nilotinib) Capsules
- Veramyst, (fluticasone furoate) Nasal Spray
- Votrient (pazopanib hydrochloride) Tablets
- Vumon (teniposide) Injection
- Vytorin (ezetimibe/simvastatin) Tablets
- Zocor (simvastatin) Tablets
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:
Commentary: Anesthesiologists Should Take Active Role in Drug Safety, Shortages
7 Top Noncompliance Issues in Medication Management
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