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

Dilaudid-HP (hydromorphone hydrochloride) Injection X   X X  
Dilaudid (hydromorphone hydrochloride) Oral Liquid and 8 mg Tablets X   X X  
Foradil Aerolizer (formoterol fumarate inhalation powder) for Oral Inhalation only X   X X X
Revlimid (lenalidomide) Capsules X   X X X
Taxotere (docetaxel) Injection Concentrate X   X   X
Tysabri (natalizumab) X X X X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Ketek (telithromycin) Tablets   X X X X
Marinol (dronabinol) Capsules  

X

  X X
Soma (carisoprodol) Tablets, USP   X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Avandaryl (rosiglitazone maleate and glimepiride) Tablets     X X X
Combivir (lamivudine/zidovudine) Tablets     X X  
Epivir (lamivudine) Tablets and Oral Solution     X X  
Hycamtin (topotecan hydrochloride) for Injection for Intravenous Use     X X X
Ultane (sevoflurane) Volatile Liquid for Inhalation     X   X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Avandia (rosiglitazone maleate) Tablets       X X
Carbatrol (carbamazepine) Extended-Release Capsules       X  
Cymbalta (duloxetine hydrochloride) Delayed-release Capsules       X  
Emend (aprepitant) Capsules, 40 mg       X X
Emend (aprepitant) Capsules, 80 mg and 125 mg       X  
Epogen (epoetin alfa)       X  
Exelon (rivastigmine tartrate) Capsules and Oral Solution       X X
Loprox (ciclopirox) Shampoo, 1%       X  
Lumigan (bimatoprost ophthalmic solution) 0.03%       X  
Prandin (repaglinide) Tablets       X X
Prinivil (lisinopril) Tablets       X X
Prinzide (lisinopril-hydrochlorothiazide) Tablets       X  
Rapamune (sirolimus) Oral Solution and Tablets       X X
Timoptic (timolol maleate ophthalmic solution) in Ocudose (Dispenser)       X  
Viagra (sildenafil citrate) Tablets       X  
Wellbutrin XL (bupropion hydrochloride extended-release tablets)       X X

Zestoretic (lisinopril/hydrochlorothiazide) Tablets

      X  
Zestril (lisinopril) Tablets       X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Adderall XR (mixed salts of single-entity amphetamine products) Capsules         X
Avastin (bevacizumab) for Intravenous Use         X
Edex (alprostadil for injection) for Intracavernous Use only         X
Leustatin (cladrabine) for Injection for Intravenous Infusion only         X
Trecator (ethionamide tablets, USP)         X

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