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Home : DrugWatch : Cordarone : FDA Information : September 2006 Safety Labeling Changes

September 2006 Safety Labeling Changes

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The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the Boxed Warning, Contraindications, or Warnings sections and a link to the revised prescribing information.

Key: BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS

DRUG NAME

 SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR
Seroquel (quetiapine fumarate) Tablets X   X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR
Cordarone (amiodarone HCl) Tablets   X X X X
Lopressor (metoprolol tartrate tablets and injection, USP)  

X

 X X X
Lopressor HCT (metoprolol tartrate, USP and hydrochlorothiazide, USP) Tablets   X X X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR
Abilify (aripiprazole) Tablets and Oral Solution     X X X
Avastin (bevacizumab) for Intravenous Use     X   X
Concerta (methylphenidate hydrochloride) Extended-Release Tablets     X X X
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules     X X  
Effexor (venlafaxine hydrochloride) Tablets     X X  
Effexor XR (venlafaxine hydrochloride) Extended- Release Capsules     X X  
Ethrane (enflurane, USP) Liquid for Inhalation     X   X
Lamictal (lamotrigine) Tablets

Lamictal (lamotrigine) Chewable Dispersible Tablets

     X X  
Magnevist (brand of gadopentetate dimeglumine) Injection     X X  
Neumega (oprelvekin)     X   X
Ortho Evra (norelgestromin/ethinyl estradiol transdermal system)     X    
Prozac (fluoxetine capsules and oral solution, USP)     X X  
Symbyax (olanzapine and fluoxetine HCl capsules)     X X  
Zarontin (ethosuximide) Capsules     X   X
(Click on drug name to go to detailed view)

BW

C

W

P

AR
Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride tablets)       X  
Actos (pioglitazone hydrochloride) Tablets       X  
Azopt (brinzolamide ophthalmic suspension) 1%       X  
Betaxon (levobetaxolol hydrochloride ophthalmic suspension), 0.5% as base       X X
Elmiron (pentosan polysulfate sodium) Capsules       X  
Enbrel (entanercept) for Subcutaneous Injection       X X
Fuzeon (enfuvirtide) for Injection       X X
Gleevec (imatinib mesylate) Tablets       X X
Hepsera (adefovir dipivoxil) Tablets       X  

IC-Green (indocyanine green for injection, USP) Sterile

 		      X  
Nascobal (cyanocobalamin, USP) Nasal Spray       X  
Nexium (esomeprazole magnesium) Delayed-Release Capsules       X X
Nexium I.V. (esomeprazole sodium) for Injection       X X
Noroxin (norfloxacin) Tablets       X  
Prilosec (omeprazole) Delayed-Release Capsules       X  
Risperdal Consta (risperidone) Long-Acting Injection       X  
Rituxan (Rituximab)       X X
WelChol (colesevelam HCL) Tablets       X  
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate       X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Atrovent HFA (ipratropium bromide HFA) Inhalation Aerosol

         X

Azmacort (triamcinolone acetonide) Inhalation Aerosol

         X

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