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The MedWatch October 2011 Safety Labeling Changes posting includes 48 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm279222.htm
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.
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
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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