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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 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 read details of changes)

C

BW

W

P

AR

Premarin (conjugated estrogen tablets, USP)

X

X

X

X

X

Thalomid (thalidomide) Capsules

X

X

 

X

X

Toprol-XL (metoprolol succinate) Extended Release Tablets

X

 

X

X

X

(Click on drug name to read details of changes)
C 
BW
W
P
AR

Novantrone (mitoxantrone) for Injection Concentrate

 

X

X

X

 

Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)

 

X

X

 
 

Rapamune (sirolimus) Oral Solution and Tablets

 

X

X

X

X

(Click on drug name to read details of changes)
 C
BW 
W 
 P
AR 

Atacand (candesartan cilexetil) Tablets

 
 

X

X

 

Gemzar (gemcitabine HCl) for Injection

 
 

X

X

X

Lopid (gemfibrozil tablets, USP)

 
 

X

 
 
(Click on drug name to read details of changes)
C
BW
W
P
AR

5% Dextrose and Potassium Chloride Injection

 
 
 

X

 

Actos (pioglitazone hydrochloride) Tablets

 
 
 

X

 

Busulfex (busulfan) Injection

 
 
 

X

 

Covera-HS (verapamil hydrochloride) Extended Release Tablets

 
 
 

X

X

Dobutamine Hydrocholoride in 5% Dextrose Injection

 
 
 

X

 

Effexor (venlafaxine hydrochloride) Tablets

 
 
 

X

X

Effexor XR (venlafaxine hydrochloride) Extended Release Capsules

 
 
 

X

X

Emla Cream (lidocaine 2.5% and prilocaine 2.5%)
Emla Anesthetic Disc (lidocaine 2.5% and prilocaine 2.5% cream)

 
 

X

X

Feldene (piroxicam) Capsules

 
 
 

X

 

Femara (letrozole tablets)

 
 
 

X

 

Imdur (isosorbide mononitrate) Extended Release Tablets

 
 
 

X

 

Larium (mefloquine hydrochloride) Tablets

 
 
 

X

 

Lithium Carbonate Capsules & Tablets USP, Lithium Citrate Syrup USP

 
 
 

X

 

Megace (megestrol acetate tablets, USP)

 
 
 

X

 

Methotrexate Sodium for Injection & Methotrexate for Injection

 
 
 

X

X

Nolvadex (tamoxifen citrate)

 
 
 

X

X

Potassium Chloride in 5% Dextrose and Lactated Ringer’s Injection

 
 
 

X

 

Pulmicort Respules (budesonide inhalation suspension)

 
 
 

X

 

Stromectol (ivermectin) Tablets

 
 
 

X

 

Sustiva (efavirenz)

 
 
 

X

 

Tenormin (atenolol) Tablets and IV Injection

 
 
 

X

 

Timolide (timolol maleate - hydrochlorothiazide) Tablets

 
 
 

X

 

Travatan (travoprost ophthalmic solution) Sterile

 
 
 

X

 

Zanosar (streptozocin sterile powder)

 
 
 

X

 

Ziac (bisoprolol fumarate and hydrochlorthiazide) Tablets

 
 
 

X

X

(Click on drug name to read details of changes)
C
BW
W
P
AR

Mesnex (mesna) Tablets and Injection

 
 
 
 

X

Oxilan (ioxilan injection)

 
 
 
 

X

Taxotere (docetaxel) for Injection Concentrate

 
 
 
 

X

Purinethol (mercaptopurine) Tablets

 
 
 
 

X

Zebeta (bisoprol fumarate) Tablets

 
 
 
 

X