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/
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/
Angeliq (drospirenone and estradiol) tablets
Aptivus (tipranavir) Capsules and Oral Solution
Avalide (irbesartan/
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/
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/
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/
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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