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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2003

 

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

Zestril (lisinopril) Tablets X   X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Retrovir (zidovudine) IV Infusion   X X X X
Viramune (nevirapine) Tablets and Suspension   X X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Lovenox (enoxaparin sodium injection)     X

X

 

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Augmentin (amoxicillin/clavulanate potassium) Tablets       X

 X

Azopt (brinzolamide ophthalmic suspension)       X  
Humatrope (somatropin [rDNA origin] for injection)       X X
Imitrex (sumatriptan) Tablets, Nasal Spray and Injection       X  
Lysodren (mitotane tablets)       X  
Nimbex (cisatracurium besylate) Injection       X

 X

Rebetol (ribavirin) Capsules        X  
Talacen (pentazocine HCl and acetaminophen) Caplets       X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Detrol (tolterodine tartrate tablets)

Detrol LA (tolterodine tartrate extended release capsules)

        X
Elavil (amitriptyline hydrochloride) Tablets and Injection         X
Zyprexa (olanzapine) Tablets

Zyprexa (olanzapine) Zydis Orally Disintegrating Tablets

        X