sábado, 19 de noviembre de 2011

Safety Information > October


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

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Safety Information > October

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