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U.S. Department of Health and Human Services

Safety

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December 2009

Drug Safety Labeling Changes

 

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, PCI=PATIENT COUNSELING INFORMATION

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

BW

C

W

P

AR

PPI/MG
Arixtra (fondaparinux sodium) injection X          
Fragmin (dalteparin sodium) injection
X
         
Innohep (tinzaparin sodium) injection X          
Lovenox (enoxaparin sodium) injection X          
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actonel (risedronate sodium) tablets   X X X    
Amlodipine besylate/ Benazepril hydrochloride capsule   X   X    
Didronel (etidronate disodium) tablets   X X X    
Innopran XL (propranolol hydrochloride) extended release capsules   X   X    
Ortho Evra (norelgestromin and ethinyl estradiol) transdermal system   X   X X PPI
Spiriva HandiHaler (tiotropium bromide) inhalation powder   X X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Arranon (nelarabine) injection     X X X  
Bicillin L-A (penicillin G benzathine) and Bicillin CR (penicillin G benzathine and penicillin G procaine) injectable suspensions     X X    
Daytrana (methylphenidate) transdermal system     X   X MG

Janumet (sitagliptin/metformin HCl) tablets 

*pancreatitis

    X X X PCI

Januvia (sitagliptin) tablets

*pancreatitis

    X X X PCI
Lexiscan (regadenoson) injection     X X X  
Seroquel (quetiapine fumarate) tablets     X X    
Seroquel XR (quetiapine fumarate) Extended-Release tablets     X X    
Topamax (topiramate) tablets and sprinkle capsules     X X    
Velcade (bortezomib) for injection     X X    
Verelan PM (verapamil hydrochloride) Extended-Release capsules     X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Famvir (famciclovir) tablets       X    
Flomax (tamsulosin hydrochloride) capsules       X    
Qualaquin (quinine sulfate) capsules       X    
Zyvox (linezolid) tablets, IV injection, and oral suspension       X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Invanz (ertapenem) injection        
X
 
Zestril (lisinopril) tablets         X  
Ziac (bisoprolol fumarate and hydrochlorothiazide) tablets         X