FDA Logo--links to FDA home page
U.S. Food and Drug Administration
HHS Log--links to Department of Health and Human Services website
FDA Home Page | About Medwatch | Contact MedWatch | MedWatch Partners
 MedWatch logoThe FDA Safety Information and Adverse Event Reporting Program


 
 

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

Cetrotide (cetrorelix acetate for injection) X     X X
Dopram Injection (doxapram hydrochloride injection, USP) X        
Vfend (voriconazole) Injection, Oral Suspension, and Tablets X     X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Premarin Intravenous (conjugated estrogens, USP for injection)   X X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Abilify (aripiprazole) Tablets     X    
Celexa (citalopram hydrobromide) Tablets and Oral Solution     X X  
Hectorol (doxercalciferol) Capsules     X X X
HepatAmine (8% amino acid injection)     X X  

Intralipid 10% Intravenous Fat Emulsion

Intralipid 20% Intravenous Fat Emulsion

Intralipid 30% Intravenous Fat Emulsion

    X X  
Lexapro (escitalopram oxalate) Tablets and Oral Solution     X X  
Premarin (conjugated estrogens tablets, USP)     X X  
Premarin (conjugated estrogens) Vaginal Cream     X X X
Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate) Tablets     X X X
Reglan (metoclopromide injection, USP)     X X X
Ultracet (tramadol hydrochloride tablets)     X    
Ultram (tramadol hydrochloride tablets)     X    
Zelnorm (tegaserod maleate) Tablets     X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Acetadote (acetylcysteine) Injection       X  
Advair Diskus 100/50 (fluticasone propionate 100 and salmeterol 50 mcg inhalation powder)       X  
Bextra (valdecoxib sodium) Tablets       X  
Corlopam (fenoldopam mesylate injection)       X X
Detrol LA (tolterodine tartrate) Extended Release Capsules       X  
Effexor (venlafaxine hydrochloride) Immediate Release Tablets       X  
Effexor XR (venlafaxine hydrochloride) Extended Release Capsules       X  
Heparin Sodium in 5% Dextrose Injection       X  
Heparin Sodium in 0.9% Sodium Chloride Injection       X  
Lac-Hydrin (ammonium lactate) Lotion       X  
Micardis HCT (telmisartan/hydrochlorothiazide) Tablets       X X

Neosporin (neomycin and polymyxin B sulfates, bacitracin zinc ophthalmic ointment, USP)

      X  
Oxandrin (oxandrolone, USP) Tablets       X  
Paxil (paroxetine hydrochloride) Controlled Release Tablets       X  
Paxil (paroxetine hydrochloride) Tablets and Oral Suspension       X  
Pipracil (piperacillin sodium) for Intravenous and Intramuscular Use       X  
Sandostatin LAR Depot (octreotide acetate injection)       X  

0.45% Sodium Chloride Irrigation Solution

0.9% Sodium Chloride Irrigation Solution

      X  
Taxotere (docetaxel) for Injection Concentrate       X X

Topicort (desoximetasone) Emollient Cream

Topicort (desoximetasone) LP Emollient Cream

      X  
Topicort (desoximetasone) Gel       X  
Topicort (desoximetasone) Ointment       X  
Trusopt (dorzolamide hydrochloride ophthalmic solution)       X X
Xanax (alprazolam) Tablets       X X
Xanax XR (alprazolam) Extended-Release Tablets       X  
Zemplar (paricalcitol) Injection       X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Cardizem LA (diltiazem hydrochloride) Extended Release Tablets

        X

Fosamax (alendronate sodium) Oral Solution

        X
        X

Mylotarg (gemtuzumab ozogamicin for Injection)

        X

Nexium. (esomeprazole magnesium) Delayed-Release Capsules

        X

Proscar (finasteride) Tablets

        X

Ziagen (abacavir sulfate) Tablets and Oral Solution

        X