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

Saizen (somatropin [rDNA origin] for injection) X   X X X
Sustiva (efavirenz) Capsules and Tablets X   X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Adderall XR (mixed salts of a single-entity amphetamine product)   X X X X
Hepsera (adefovir dipivoxil) Tablets  

X

X   X
Vivelle (estradiol transdermal system)   X X X  
Vivelle-Dot (estradiol transdermal system)   X X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Actos (pioglitazone HCl) Tablets     X    
Amicar (aminocaproic acid) Tablets, Injection and Syrup     X X  

Geodon (ziprasidone HCl) Capsules

Geodon (ziprasidone mesylate) for Injection (for IM Use Only)

    X X X
Junior Strength Advil (100 mg ibuprofen) Tablets     X    
Lotrel (amlodipine besylate and benazepril hydrochloride) Combination Capsules     X    
Naropin (ropivacaine HCl) Injection     X X  
Orudis KT (ketoprofen) Tablets     X  
Pexeva (paroxetine mesylate) Tablets     X X  
Prozac (fluoxetine hydrochloride) Pulvules, Tablets, Solution and Delayed-Release Capsules      X X  
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate     X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Accutane (isotretinoin) Capsules       X  
Anadrol-50 (oxymetholone) Tablets       X  
Arimidex (anastrozole) Tablets       X X
Augmentin (amoxicillin/clavulanate potassium) Chewable Tablets and Powder for Oral Suspension       X  
Augmentin (amoxicillin/clavulanate potassium) Tablets       X  
Ciloxan (ciprofloxacin hydrochloride ophthalmic solution)       X  
Elmiron (pentosan polysulfate sodium) Capsules       X X
Ferrlecit (ferric sodium gluconate complex in sucrose injection)       X X
Kytril (granisetron) Injection       X  
Persantine (dipyridamole) Tablets       X  
Rhinocort Aqua (budesonide) Nasal Spray       X  

Rifadin (rifampin capsules USP)

Rifadin IV (rifampin for injection USP)

      X  
Taxotere (docetaxel) for Injection Concentrate       X X
Trobicin Sterile Powder (spectinomycin hydrochloride for injectable suspension, USP)       X  
Unasyn (ampicillin sodium/sulbactam sodium) for Injection       X  
Vioxx (rofecoxib) Tablets and Suspension       X X
Zelnorm (tegaserod maleate) Tablets       X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Alimta (pemetrexed for injection)         X
Topamax (topiramate) Tablets and Sprinkle Capsules         X
Ziagen (abacavir sulfate) Tablets and Oral Solution         X