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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2006

 

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, 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 Boxed Warning, Contraindications, or Warnings sections and a link to the revised prescribing information.

Key: BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS

 
DRUG NAME SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Premarin Intravenous (conjugated estrogens, USP) for Injection X   X X  
Premarin (conjugated estrogens tablets, USP) X   X    
Premarin (conjugated estrogens) Vaginal Cream X   X X  
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets)
Premphase (conjugated estrogens/medroxyprogesterone tablets)
X   X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Camptosar (irinotecan hydrochloride injection) for Intravenous Use Only   X   X X
Oncaspar (pegaspargase) Intravenous or Intramuscular Injection  

X

X X X
Symbyax (olanzapine and fluoxetine HCl capsules)   X   X X
Zanaflex (tizanidine hydrochloride) Capsules and Tablets   X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Adderall (mixed salts of a single-entity amphetamine product) Tablets     X X X
Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules     X X X
Alimta (pemetrexed for injection)     X   X

Biaxin Filmtab (clarithromycin tablets, USP)

Biaxin XL Filmtab (clarithromycin extended-release tablets)

Biaxin Granules (clarithromycin for oral suspension, USP)

    X X X
Celestone Soluspan (betamethasone sodium phosphate and betamethasone acetate injectable suspension, USP)     X X  
Celestone (betamethasone syrup, USP)     X X  
Daytrana (methylphenidate transdermal system)     X    
Retrovir (zidovudine) IV Infusion for Intravenous Infusion Only     X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Famvir (famciclovir) Tablets       X X
Oxytrol (oxybutynin transdermal system)       X X
Propranolol Hydrochloride Injection, USP       X X
Protonix (pantoprazole sodium) Delayed-Release Tablets       X  
Revatio (sildenafil citrate) Tablets       X  
Risperdal Consta (risperidone) Long-Acting Injection       X X
Triglide (fenofibrate) Tablets       X  
Tygacil (tigecycline) for Injection       X X
Wellbutrin (bupropion hydrochloride) Tablets       X  
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets       X  
Zosyn (piperacillin and tazobactam for Injection)       X X
Zosyn (piperacillin and tazobactam) in Galaxy Containers       X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Elspar (asparaginase)

        X
Gemzar (gemcitabine HCl) for Injection         X
Tagamet (cimetidine) Tablets         X
Vytorin (ezetimibe/simvastatin) Tablets         X
WelChol (colesevelam hydrochloride) Tablets         X

Zantac (ranitidine hydrochloride) Injection
Zantac (ranitidine hydrochloride) Injection Premixed

        X

Zantac (ranitidine hydrochloride)  Tablets and Syrup
Zantac (ranitidine hydrochloride) EFFERdose Tablets

        X

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