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February 2012 Medication Label Changes

Last month brought changes to sixty-five (65) medical product labels (up from 63 changes in February), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

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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