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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 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
Desoxyn (methamphetamine hydrochloride tablets, USP) X
 
X
 
MG 
Tindamax (tinidazole) Tablets for Oral Use
X
X
 X
X
 
Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets
X
 
 X
X
PPI
Viread (tenofovir disoproxil fumarate) Tablets
X
 
 X
X
X
PPI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Lovenox (enoxaparin sodium injection) for Subcutaneous and Intravenous Use    X X X
X
 
Norditropin Cartridges [somatropin (rDNA origin) injection] for Subcutaneous Use  

X

X X
X
 
Rocephin (ceftriaxone sodium) for Injection   X X  
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Aptivus (tipranvir) Capsules     X  
 
 

Avelox (moxifloxacin hydrochloride) Tablets

Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection)

    X X
 
PPI
ChloraPrep (2% chlorhexidine gluconate (w/v) topical solution) 3-mL applicator with tint applicator containing FD&C Green #3 dye     X  
 
 
Doxil (doxorubicin HCl liposome injection)     X X
 
Factive (gemifloxacin mesylate) Tablets     X X
PPI
Floxin Tablets (ofloxacin tablets)     X X
 
 
Fragmin (dalteparin sodium injection) for Subcutaneous Use Only     X X X  

Geodon (ziprasidone HCl) Capsules

Geodon (ziprasidone mesylate) for Injection for IM Use Only

    X   X  
Haldol Decanoate (haloperidol) for IM Injection Only     X  
X
 
Haldol (haloperidol) Injection for Immediate Release     X   X  

Levaquin (levofloxacin) Tablets and Oral Solution

Levaquin (levofloxacin) Injection

Levaquin (levofloxacin in 5% dextrose) Injection

    X X X PPI
NegGram Caplets (nalidixic acid, USP)     X X    
Norvir (ritonavir capsules) Soft Gelatin (ritonavir oral solution)     X X    
PegIntron (peginterferon alfa-2b) Powder for Injection     X   X MG
Plavix (clopidogrel bisulfate tablets)     X X    
Rapamune (sirolimus) Oral Solution and Tablets     X X X  
Tygacil (tigecycline) for Injection     X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules       X
 
MG
Anzemet Injection (dolasetron mesylate injection)       X
 
 
Anzemet Tablets (dolasetron mesylate)       X
 
 
BenzaClin Topical Gel (clindamycin - benzoyl peroxide gel)       X
 
 
Concerta (methylphenidate HCl) Extended-Release Tablets       X
 
MG
Daytrana (methylphenidate transdermal system)       X
 
MG
Dexedrine (dextroamphetamine sulfate) Spansule Sustained-Release Capsules and Tablets       X
 
MG
Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules       X
 
MG
MS Contin (morphine sulfate controlled-release) Tablets       X
 X
 

Ortho Tri-Cyclen Tablets and Ortho-Cyclen Tablets

(norgestimate/ethinyl estradiol)

      X
 
 
Prevpac (lansoprazole 30-mg capsules, amoxicillin 500-mg capsules, USP, and clarithromycin 500-mg tablets, USP)       X
X
 

Primacor (milrinone lactate injection)

Primacor Flexible Containers (200 mcg/mL in 5% Dextrose Injection)

      X
 X
 
Verelan PM (verapamil hydrochloride) Extended-Release Capsules Controlled Onset       X
 
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Dyazide (hydrochlorothiazide/triamterene) Capsules        
X
 
Intron A (interferon alfa-2b, recombinant) for Injection        
X
 
Prevacid I.V. (lansoprazole) for Injection        
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Levemir FlexPen (insulin detemir [rDNA origin] injection) in a 3 mL Prefilled Syringe
 
 
 
 
 
PPI 
Levemir (insulin detemir [rDNA origin] injection) 3 mL PenFill Disposable Cartridge
 
 
 
 
 
PPI
Naprelan (naproxen sodium) Controlled Release Tablets
 
 
 
 
 
MG

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