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

Sporanox (itraconazole) Capsules X X X X X
Sporanox (itraconazole) Injection X   X X X X
Ziagen (abacavir sulfate) Tablets and Oral Solution X X X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
 Delestrogen (estradiol valerate injection, USP)   X X X  
 Prefest (estradiol/norgestimate) Tablets  

X

X X  
 Viread (tenofovir disoproxil fumerate) Tablets   X X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Advil (ibuprofen) Tablets, Caplets and Gel Caplets     X    
Avelox (moxifloxacin hydrochloride) Tablets     X    
ChloraPrep One Step (chlorhexidine gluconate 2% topical solution)     X    
Cipro (ciprofloxacin) IV for Intravenous Infusion     X X X
Cipro (ciprofloxacin hydrochloride) Tablets and Oral Suspension     X X X
Cipro XR (ciprofloxacin extended-release tablets)     X X X
Noroxin (norfloxacin) Tablets     X X X
Purinethol (mercaptopurine) Tablets     X X  
Rapamune (sirolimus) Tablets and Oral Solution     X X X
Reyataz (atazanavir sulfate) Capsules     X   X
Thallous Chloride T1-201     X   X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Actos (pioglitazone HCl) Tablets       X  

Biaxin Filmtab (clarithromycin tablets, USP)

Biaxin Granules (clarithromycin for oral suspension, USP)

Biaxin XL Filmtab (clarithromycin extended-release tablets)

      X  
Botulinum Toxin Type A       X X
Factive (gemifloxacin mesylate) Tablets       X  
Mobic (meloxicam) Tablets and Oral Suspension       X X
NovoLog (insulin aspart [rDNA origin] injection)       X  
Prevpac (lansoprazole/amoxicillin/clarithromycin)       X X
Reglan (metoclopromide, USP) Tablets       X  
Rhinocort Aqua (budesonide) Nasal Spray       X  
Starlix (nateglinide) Tablets       X  
Zetia (ezetimibe) Tablets       X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension)

        X

Integrilin (eptifibatide)  Injection

        X

Lipitor (atorvastatin calcium) tablets

        X

Rocaltrol (calcitriol) Capsules and Oral Solution

        X

Zomig (zolmitriptan) Nasal Spray

        X