MedWatch February 2012 Safety Labeling Changes

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The MedWatch February 2012 Safety Labeling Changes posting includes 65 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm294217.htm

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:  

Monthly Safety Labeling Changes includes 65 products with revisions to Prescribing Information. Posted 03/15/2012

Abilify (aripiprazole) Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection  
Amturnide (amlodipine/aliskiren/hydrochlorothiazide) tablets
Angeliq (drospirenone and estradiol) tablets
Aptivus (tipranavir) Capsules and Oral Solution
Avalide (irbesartan/hydrochlorothiazide) tablets 
Benicar (olmesartan medoxomil) Tablets   
Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
Cardiogen-82 (Rubidium Rb 82 Generator)   
Crestor (rosuvastatin calcium) Tablets
Crixivan (indinavir sulfate) Capsules
Diovan HCT (valsartan/hydrochlorothiazide) Tablets  
EES (erythromycin ethylsuccinate) Granules for oral suspension, Eryc (erythromycin delayed-release) capsules, Ery-Ped liquid and
PCE (erythromycin particles in tablets) 333 mg and 500 mg film coated tablets     
Elestrin (estradiol gel)
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets
Famvir (famciclovir) Tablets
Hepsera (adefovir dipivoxil) tablets
Invirase (saquinavir mesylate) Capsules and Tablets
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution
Lescol (fluvastatin sodium) Capsules
Lescol XL (fluvastatin sodium) Extended-Release Tablets
Letairis (ambrisentan) Tablets 
Lexiva (fosamprenavir calcium) tablets and oral suspension
Lipitor (atorvastatin calcium) Tablets
Livalo (pitavastatin) tablets   
Lotensin HCT (benazepril HCl and hydrochlorothiazide) Tablets
Mevacor (lovastatin) Tablets 
Natazia (estradiol valerate and estradiol valerate/dienogest) tablets    
Norvir (ritonavir) oral solution and tablets
Orencia (abatacept) for injection   
Ozurdex (dexamethasone intravitreal) implant 
Patanase (olopatadine hydrochloride) Nasal Spray
Phendimetrazine tartrate SR 105 mg capsules  
Pravachol (pravastatin sodium) Tablets
Premarin (conjugated estrogens) Vaginal Cream
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets
Prezista (darunavir), Oral suspension
Reyataz (atazanavir sulfate) Capsules    
Rituxan (rituximab) Intravenous Injection
Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
Simcor (niacin ER/simvastatin) Tablets
Tekamlo (aliskiren/amlodipine) tablets 
Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets
Valturna (aliskiren/valsartan) tablets
Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets   
Vasotec (enalapril maleate) Tablets   
Viracept (nelfinavir mesylate) Oral Powder
Vytorin (ezetimibe/simvastatin) Tablets 
Xalkori (crizotinib) Capsules
Yasmin (drospirenone/ethinyl estradiol) tablets
Zocor (simvastatin) Tablets   
Zyvox (linezoid) Tablets and Oral Suspension

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