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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2007

 

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE 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 to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS
AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

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

BW

C

W

P

AR

PPI/MG
Tasmar (tolcapone) Tablets X    
X
X
 
Toradol (ketorolac tromethamine tablets) X X X X   MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Sustiva (efavirenz) Capsules and Tablets   X   X   PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Minocin (minocycline for injection) Intravenous     X X    
Minocin (minocycline hydrochloride) Oral Suspension     X X    
Mobic (meloxicam) Tablets and Oral Suspension     X X    
Rapamune (sirolimus) Oral Solution and Tablets     X X X  
Zevalin (ibritumomab tiuxetan)     X   X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actimmune (interferon gamma-1b)       X X  
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets       X X  
Cialis (tadalafil) Tablets       X    
Desferal (deferoxamine mesylate injection, USP)       X    
Eloxatin (oxaliplatin) Powder, for Solution for Intravenous Use       X    
Flomax (tamsulosin hydrochloride) Capsules       X   PPI
Inderal LA (propranolol hydrochloride) Long-Acting Capsules       X    
Indocin (indomethacin) Capsules, Oral Suspension, and Suppositories       X    
Indocin I.V. (indomethacin for injection)       X    
Lipitor (atorvastatin calcium) Tablets       X X  
NovoLog (insulin aspart [rDNA origin]) Injection       X   PPI
Progesterone Injection, USP in Sesame Oil for Intramuscular Use Only       X X PPI
Transderm Scōp (transdermal scopolamine) System       X   PPI
Wellbutrin (bupropion hydrochloride) Tablets       X X MG
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets       X X MG
Xenical (orlistat) Capsules       X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Vidaza (azacitidine for injection) for Subcutaneous and Intravenous Use Only         X  
Xifaxan (rifaximin) Tablets         X  
Yaz (drospirenone and ethinyl estradiol) Tablets         X PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Minocin (minocycline hydrochloride) Pellet-Filled Capsules           PPI
Ovcon 35 Fe (norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets)           PPI

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