Drug Safety Labeling Changes - February 2010

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February 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) tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Cialis (tadalafil) tablets-ContraindicationsWarningsPrecautions----
Accutane (isotretinoin) capsules--Warnings-----
Carbocaine (mepivacaine HCl) injection--Warnings-----
Didrex (benzphetamine hydrochloride) tablets--WarningsPrecautionsAdverse Reactions---
Excedrin Migraine (250 mg acetaminophen/ 250 mg aspirin/ 65 mg caffeine) tablets--Warnings-----
Genotropin (somatropin [rDNA origin] for injection--WarningsPrecautions----
Lanoxin (digoxin) pediatric injection and tablets--Warnings-----
Marcaine Spinal (bupivacaine HCl) dextrose injection--Warnings-----
Naropin (ropivacaine HCl) injection--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Nesacaine-MPF (chloroprocaine HCl) injection--Warnings-----
Prepidil (dinoprostone) cervical gel--Warnings-----
Rocephin (ceftriaxone sodium) IV and IM--Warnings-----
Treanda (bendamustine hydrochloride) for injection, for intravenous infusion--WarningsPrecautions----
Xylocaine (lidocaine HCl) 4% solution--Warnings-----
Cefoxitin for injection and Dextrose injection in the Duplex container---Precautions----
Intelence (etravirine) 100 mg tablets---Precautions----
Dyazide (hydrochlorothiazide/triamterene) capsules----Adverse Reactions---
Forane (isoflurane) liquid for inhalation----Adverse Reactions---
Niaspan (niacin) extended release tablets----Adverse Reactions---
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