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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2004

 

The summary view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, 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 Contraindications or Warnings sections and a link to the revised prescribing information.

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

 

DRUG NAME

SECTIONS MODIFIED

(Click on drug name to go to detailed view)

C

BW

W

P

AR

Lovenox (enoxaparin sodium injection) X        
Lupron (leuprolide acetate) Injection X   X X X
Nutropin Depot (somatropin [rDNA origin] for injectable suspension) X   X    
Roferon-A (interferon alfa-2a, recombinant) X X X X
Tikosyn (dofetilide) Capsules X   X X  
Vesanoid (tretinoin) Capsules X X X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Doxil (doxorubicin HCl) Liposome Injection   X X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Altace (ramipril) Capsules     X X X
Axid AR (nizatidine)     X    
Concerta (methylphenidate HCl) Extended-release Tablets     X   X
Cuprimine (penicillamine) Capsules     X X  
Enbrel (etanercept)     X   X
Fuzeon (enfuvirtide) for Injection     X X X
Kaletra (lopinavir/ritonavir) Capsules and Oral Solution     X X X
Levaquin (levofloxacin) Tablets, Oral Solution and Injection

Levaquin (levofloxacin in 5% dextrose) Injection

    X X  
Pepcid AC (famotidine) Chewable Tablets     X    
Pepcid Complete (famotidine, calcium carbonate & magnesium hydroxide)     X    
Pepcid AC (famotidine) Gelcaps     X    
Pepcid AC (famotidine) Maximum Strength Film Coated Tablets     X    
Pepcid AC (famotidine) Original Strength Film Coated Tablets     X    
Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets     X   X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Diflucan (fluconazole) Tablets, Injection and Powder for Oral Suspension       X X
Imitrex (sumatriptan) Nasal Spray       X  
Plavix (clopidogrel bisulfate) Tablets       X X
Propecia (finasteride) Tablets       X X
Reyataz (atazanavir sulfate) Capsules       X  
Sustiva (efavirenz) Tablets and Capsules       X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Femara (letrozole tablets)

        X

Geodon (ziprasidone HCl) Capsules

Geodon (ziprasidone mesylate) for Injection

        X

Keppra (levetiracetam) Tablets and Oral Solution

        X

Kineret (anakinra)

        X

Xenical (orlistat) Capsules

        X