Drug Safety Labeling Changes - March 2010

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March 2010

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
Caduet (amlodipine besylate/atorvastatin calcium) tablet-ContraindicationsWarningsPrecautionsAdverse Reactions---
Lotrel (amlodipine besylate/benazapril hydrochloride) capsule-ContraindicationsWarningsPrecautionsAdverse Reactions---
Meridia (sibutramine hydrochloride) capsules-ContraindicationsWarningsPrecautions----
Skelid (tiludronate disodium) tablets-ContraindicationsWarningsPrecautions----
Avelox (moxifloxacin) tablets and I.V.--Warnings-Adverse Reactions---
ChloraPrep [chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v)] solution [OTC]--Warnings-----
DuraPrep Surgical (iodine povacrylex (0.7% available iodine) and isopropyl alcohol (74% w/w)) solution--Warnings-----
Emend (fosaprepitant dimeglumine) for injection--WarningsPrecautions----
Femara (letrozole) 2.5 mg tablets--WarningsPrecautionsAdverse Reactions---
Hycamtin (topotecan hydrochloride) injection--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Toprol XL (metoprolol succinate) extended release tablets--Warnings-Adverse Reactions---
Vivitrol (naltrexone for extended-release) injectable suspension--WarningsPrecautions----
Adalat (nifedipine) extended release tablets---Precautions----
Cardura XL (doxazosin mesylate) extended release tablets---Precautions----
Isoptin SR (verapamil HCL) sustained release tablets---Precautions----
Nexium (esomeprazole magnesium) capsules, oral suspension, and for injection---Precautions----
Percodan (oxycodone and aspirin) tablets---Precautions----
Prilosec (omeprazole magnesium) delayed-release capsules and oral suspension---Precautions----
Propecia (finasteride) 1 mg tablet---Precautions----
Vanos (fluocinonide) cream---Precautions----
Drug Name BW C W P AR PPI MG PCI
Verelan (verapamil hydrochloride) capsule---Precautions----
Copegus (ribavirin) tablet----Adverse Reactions---
Dexilant (former Kapidex) (dexlansoprazole) delayed release capsules----Adverse Reactions---
Emend (aprepitant) capsules----Adverse Reactions---
Exforge (amlodipine and valsartan) tablets----Adverse Reactions---
Inderide (propranolol HCl/hydrochlorothiazide) tablets----Adverse Reactions---
Invega (paliperidone) extended-release tablets----Adverse Reactions---
Isentress (raltegravir potassium) tablets----Adverse Reactions---
Pepcid (famotidine) tablets----Adverse Reactions---
Relenza (zanamivir) Inhalation Powder for oral inhalation----Adverse Reactions---
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