Drug Safety Labeling Changes - November 2009

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November 2009

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
Actiq (fentanyl citrate) oral transmucosalBoxed Warning-------
Cimzia (certolizumab pegol)Boxed Warning-WarningsPrecautionsAdverse Reactions---
Cleocin HCL (clindamycin hydrochloride) capsulesBoxed Warning-WarningsPrecautions----
Enbrel (etanercept)Boxed Warning-WarningsPrecautions----
Humira (adalimumab) injectionBoxed Warning-WarningsPrecautionsAdverse Reactions---
Qualaquin (quinine sulfate) 324 mg capsulesBoxed Warning-Warnings-----
Remicade (infliximab) for IV injectionBoxed Warning-Warnings-----
Lotensin (benazepril hydrochloride) tablets-Contraindications------
Lotensin HCT (benazepril/hydrochlorothiazide) tablets-Contraindications--Adverse Reactions---
Norvir (ritonavir) capsule and solution-ContraindicationsWarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Parnate (tranylcypromine sulfate) tablets-Contraindications------
Adenocard (adenosine) 3 mg/mL injection--Warnings-----
Adenoscan (adenosine) 3 mg/mL injection--Warnings-----
Avandaryl (rosiglitazone maleate and glimepiride) tablets--WarningsPrecautions----
Lopressor (metoprolol tartrate) tablets and ampules for injection--WarningsPrecautions----
Plavix (clopidogrel bisulfate) 75 mg tablets--WarningsPrecautions----
Rebetol (ribavirin) capsules and solution--WarningsPrecautions----
Rilutek (riluzole) tablets--WarningsPrecautionsAdverse Reactions---
Soma Compound with Codeine (carisoprodol 200 mg, aspirin 325 mg and codeine phosphate 16 mg) tablets--WarningsPrecautions----
Truvada (emtricitabine/tenofovir disoproxil fumarate tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Altace (ramipril) tablets---Precautions----
Catapres-TTS (clonidine) trandsdermal therapeutic system---PrecautionsAdverse Reactions---
Effexor (venlafaxine HCl) tablets and Effexor XR (venlafaxine HCl) Extended-Release capsules---Precautions----
Avelox (moxifloxacin) IV and tablets----Adverse Reactions---
Cordarone (amiodarone HCl) 200 mg tablets----Adverse Reactions---
Isentress (raltegravir potassium) 400 mg tablets----Adverse ReactionsPatient Package Insert--
Pristiq (desvenlafaxine) Extended-Release tablets----Adverse Reactions---
Relistor (methylnaltrexone bromide) Subcutaneous injection----Adverse ReactionsPatient Package Insert--
Sensipar (cinacalcet HCl) tablets----Adverse Reactions---
Urso 250 and Urso Forte (ursodiol) tablets  ----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Vytorin (ezetimibe/simvastatin) tablets----Adverse ReactionsPatient Package Insert--
Zestril (lisinopril) tablets----Adverse Reactions---
Actoplus Met (pioglitazone HCl + metformin HCl) fixed-dose combination tablets--------
Retrovir (zidovudine) capsules, tablets--------
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