Drug Safety Labeling Changes - February 2012

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February 2012

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Amturnide (amlodipine/aliskiren/hydrochlorothiazide) tabletsBoxed Warning-WarningsPrecautionsAdverse Reactions---
Cardiogen-82 (Rubidium Rb 82 Generator)Boxed Warning-WarningsPrecautions----
Tekamlo (aliskiren/amlodipine) tabletsBoxed Warning-WarningsPrecautions----
Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) TabletsBoxed Warning-WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Valturna (aliskiren/valsartan) tabletsBoxed Warning-WarningsPrecautions----
Vaseretic (enalapril maleate/hydrochlorothiazide) TabletsBoxed Warning-WarningsPrecautions----
Vasotec (enalapril maleate) TabletsBoxed Warning-WarningsPrecautions----
Angeliq (drospirenone and estradiol) tablets-ContraindicationsWarningsPrecautions----
Crixivan (indinavir sulfate) Capsules-ContraindicationsWarningsPrecautions-Patient Package Insert--
Elestrin (estradiol gel)-ContraindicationsWarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Mevacor (lovastatin) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Phendimetrazine tartrate SR 105 mg capsules-Contraindications-PrecautionsAdverse Reactions---
Premarin (conjugated estrogens) Vaginal Cream-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Viracept (nelfinavir mesylate) Oral Powder-ContraindicationsWarningsPrecautions-Patient Package Insert--
Abilify (aripiprazole) Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection--WarningsPrecautions----
Aptivus (tipranavir) Capsules and Oral Solution--WarningsPrecautions-Patient Package Insert--
Avalide (irbesartan/hydrochlorothiazide) tablets--WarningsPrecautionsAdverse Reactions---
Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets--WarningsPrecautions----
EES (erythromycin ethylsuccinate) Granules for oral suspension, Eryc (erythromycin delayed-release) capsules, Ery-Ped liquid and--Warnings-----
Drug Name BW C W P AR PPI MG PCI
PCE (erythromycin particles in tablets) 333 mg and 500 mg film coated tablets--Warnings-----
Invirase (saquinavir mesylate) Capsules and Tablets--WarningsPrecautions-Patient Package Insert--
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution--WarningsPrecautions-Patient Package Insert--
Lescol (fluvastatin sodium) Capsules,--WarningsPrecautionsAdverse Reactions---
Lescol XL (fluvastatin sodium) Extended-Release Tablets--WarningsPrecautionsAdverse Reactions---
Lipitor (atorvastatin calcium) Tablets--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Lotensin HCT (benazepril HCl and hydrochlorothiazide) Tablets--WarningsPrecautionsAdverse Reactions---
Natazia (estradiol valerate and estradiol valerate/dienogest) tablets--WarningsPrecautions----
Norvir (ritonavir) oral solution and tablets--WarningsPrecautions----
Orencia (abatacept) for injection--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Ozurdex (dexamethasone intravitreal) implant--WarningsPrecautionsAdverse Reactions---
Patanase (olopatadine hydrochloride) Nasal Spray--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Pravachol (pravastatin sodium) Tablets--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Prezista (darunavir), Oral suspension--WarningsPrecautions-Patient Package Insert--
Reyataz (atazanavir sulfate) Capsules--WarningsPrecautions----
Rituxan (rituximab) Intravenous Injection--WarningsPrecautionsAdverse Reactions---
Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets--WarningsPrecautions----
Yasmin (drospirenone/ethinyl estradiol) tablets--WarningsPrecautions-Patient Package Insert--
Zyvox (linezoid) Tablets, Oral Suspension--Warnings-Adverse Reactions---
Kaletra (lopinavir/ritonavir) Capsules---Precautions-Patient Package Insert--
Drug Name BW C W P AR PPI MG PCI
Norvir (ritonavir) Capsules---Precautions-Patient Package Insert--
Vaprisol (conivaptan) injection---Precautions----
Vexol (rimexolone ophthalmic suspension) 1%---Precautions----
Arranon (nelarabine) injection----Adverse Reactions---
Precose (acarbose) Tablets----Adverse Reactions---
Sodium Iodide I-131 Therapeutic Capsules and Therapeutic Solution----Adverse Reactions---
Theophylline in 5% Dextrose in the Excel Plastic Container----Adverse Reactions---
Januvia (sitagliptin) tablets (PPI/MG)-----Patient Package Insert--
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