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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 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
Definity Vial for (perflutren lipid microsphere) Injectable Suspension For Intravenous Use

X

 X
X
 
Elaprase (idursulfase) Solution For Intravenous Infusion
X
 
 
X
 
Erbitux (cetuximab) Solution For Intravenous Use
X
 
 X
 
Soriatane (acitretin) Capsules
X
X
 
 X
 
MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Aptivus (tipranavir) Capsules   X X X
PPI
Azithromycin for Injection For I.V. Infusion Only  

X

   
X
 
DDAVP Injection (desmopressin acetate) 4 mcg/mL   X X X X  
DDAVP Nasal Spray (desmopressin acetate)   X X X X PPI
DDAVP Rhinal Tube (desmopressin acetate)   X X X X PPI
DDAVP Tablets (desmopressin acetate)   X X X X  
Inderal LA (propranolol hydrochloride) Long-Acting Capsules   X X X X  
Januvia (sitagliptin) Tablets   X X X
X
PPI
Lodine (etodolac capsules and tablets)   X X X
X
 
Prevpac (lansoprazole 30-mg capsules, amoxicillin 500-mg capsules, USP, and clarithromycin 500-mg tablets, USP)   X X X X  

ProQuad [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live] Frozen Formulation

  X     X  

ProQuad [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live] Refrigerator-Stable Formulation

  X     X  
Zithromax (azithromycin tablets and azithromycin for oral suspension)   X     X  
Zmax (azithromycin extended release) For Oral Suspension   X     X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cubicin (daptomycin for injection)     X X
 
 
Dalmane (flurazepam hydrochloride) Capsules     X X
 
 
Doral (quazepam tablets, USP)     X X
 
MG
Lexxel (enalapril maleate-felodipine ER) Tablets     X X
 
 
Lymphazurin 1% (isosulfan blue) Aqueous Solution     X X
 
 
NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) For Vaginal Use Only     X X
 
 
Rapamune (sirolimus) Oral Solution and Tablets     X X X  
Renagel (sevelamer hydrochloride) Tablets For Oral Use     X X X  
Vaseretic (enalapril maleate - hydrochlorothiazide) Tablets     X X    
Vasotec (enalapril maleate) Tablets     X X    
Visken (pindolol) Tablets, USP     X      
Zestoretic (lisinopril and hydrochlorothiazide) Tablets     X X X  
Zestril (lisinopril) Tablets     X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Abilify (aripiprazole) Tablets

Abilify DISCMELT (aripiprazole) Orally Disintegrating Tablets

Abilify (aripiprazole) Oral Solution

Abilify (aripiprazole) Injection For Intramuscular Use Only

      X
X
 
Accutane (isotretinoin capsules)       X
 
 
Adagen (pegademase bovine) Injection       X
 
 
Cialis (tadalafil) Tablets       X
PPI
Coreg CR (carvedilol phosphate) Extended-release Capsules       X
 
 
Levitra (vardenafil hydrochloride) Tablets       X
PPI
Lexiva (fosamprenavir calcium) Tablets and Oral Suspension       X
X
 
Retisert (fluocinolone acetonide intravitreal implant) 0.59 mg       X
 
 
Rhinocort Aqua (budesonide) Nasal Spray 32 mcg       X
 
 

Symbicort 80/4.5 (budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol

Symbicort 160/4.5 (budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol

For Oral Inhalation Only

      X
 
MG
Tamiflu (oseltamivir phosphate) Capsules and For Oral Suspension       X
 
PPI
Velcade (bortezomib) For Injection       X
 
 
Viagra (sildenafil citrate) Tablets       X
X
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cordarone (amiodarone HCl) Tablets        
X
 

Geodon (ziprasidone HCl) Capsules

Geodon (ziprasidone mesylate) for Injection For IM Use Only

       
X
 
Vivitrol (naltrexone for extended-release injectable suspension)        
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Ambien (zolpidem tartrate) Tablets
 
 
 
 
 
MG 
depo-subQ provera 104 for Subcutaneous Use           PPI

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