FDA Logo--links to FDA home page
U.S. Food and Drug Administration
HHS Log--links to Department of Health and Human Services website
FDA Home Page | About MedWatch | Contact MedWatch | MedWatch Partners
 MedWatch logoThe FDA Safety Information and Adverse Event Reporting Program


 
 

Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 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
Anafranil (clomipramine hydrochloride capsules, USP) X    
X X    
MG
Baraclude (entecavir) Tablets and Oral Solution X   X X    
PPI
Emsam (selegiline transdermal system) Continuous Delivery for Once-Daily Application X   X X   MG
EstroGel 0.06% (estradiol gel) X   X X X PPI
Norpramin (desipramine hydrochloride tablets, USP) X   X X   MG
Nortriptyline Hydrochloride Oral Solution, USP X   X X   MG
Pamelor (nortriptyline HCl) Capsules and Oral Solution, USP X   X X   MG
Remeron (mirtazapine) Tablets X   X X   MG
RemeronSolTab
(mirtazapine) Orally Disintegrating Tablets
X   X X   MG
Seroquel (quetiapine fumarate) Tablets X   X X   MG
Tofranil-PM (imipramine pamoate capsules) X   X X   MG
Xolair (omalizumab) for Subcutaneous Use X   X X X MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Aygestin (norethindrone acetate tablets, USP)   X X X X PPI
Dipentum (olsalazine sodium capsules)  

X

  X X  
Intron A (interferon alfa-2b, recombinant) for Injection   X X X X MG
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Ceftin Tablets (cefuroxime axetil tablets)

Ceftin for Oral Suspension (cefuroxime axetil powder for oral suspension)

    X X  
 
Crestor (rosuvastatin calcium) Tablets     X X  
Evista (raloxifene hydrochloride) Tablets     X X  
PPI

Fortaz (ceftazidime for injection)

Fortaz (ceftazidime injection)

    X X  
 
Invirase (saquinavir mesylate) Capsules and Tablets     X X  
PPI
Neulasta (pegfilgrastim)     X   X PPI
Rocephin (ceftriaxone sodium) for injection     X X    
Viracept (nelfinavir mesylate) Tablets and Oral Powder     X X  
 
Zestoretic (lisinopril and hydrochlorothiazide)     X X    
Zestril (lisinopril)     X X  
 

Zinacef (cefuroxime for injection)

Zinacef (cefuroxime injection)

    X X  
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Clarinex-D 12 Hour Extended Release Tablet (desloratadine and pseudoephedrine sulfate, USP)       X  
 
Delatestryl (testosterone enanthate Injection, USP)       X  
 
Humalog (insulin lispro [rDNA origin] injection) 100 Units/mL       X  
PPI
Kaletra (lopinavir/ritonavir) Capsules and Oral Solution       X  
 
Norvir (ritonavir capsules) Soft Gelatin and (ritonavir oral solution)       X  
 
Serostim (somatropin [rDNA origin] for injection)       X X  
Toprol XL (metoprolol succinate) Extended-Release Tablets       X  
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Calcijex (calcitriol injection)         X  
Crixivan (indinavir sulfate) Capsules         X  
Humira (adalimumab) Solution for Subcutaneous Injection         X  
Ovidrel (choriogonadotropin alfa injection) for Subcutaneous Use         X  
VESIcare (solifenacin succinate) Tablets            

Zyprexa (olanzapine tablets)

Zyprexa Zydis (olanzapine orally disintegrating tablets)

Zyprexa IntraMuscular (olanzapine for injection)

        X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actonel (risedronate sodium) Tablet, Film Coated  
 
 
 
 
PPI
Daypro Alta (oxaprozin potassium) Tablets  
 
 
 
 
MG
Feldene (piroxicam) Capsules           MG

Oruvail Extended-Release (ketoprofen extended-release) Capsule

Orudis (ketoprofen) Capsule

          MG
Voltaren (diclofenac sodium enteric-coated tablets)  
 
 
 
 
MG

MedWatch Home | Safety Info | Submit Report | How to Report | Download Forms | Join E-list | Articles & Pubs | Comments | Partners
FDA Home Page | Privacy | Accessibility | HHS Home Page