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U.S. Department of Health and Human Services

Safety

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September 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

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

BW

C

W

P

AR

PPI/MG
AndroGel (testosterone gel) 1% for topical use X   X X X PCI
Rapamune (sirolimus) oral solution and tablets
X
  X X    
Testim (testosterone gel) 1% topical gel
X
  X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cordarone (amiodarone HCl) 200 mg tablets     X   X MG
Flector Patch (diclofenac epolamine) 1.3% topical patch     X      
Intelence (etravirine) tablets     X X X  
Kayexalate (sodium polystyrene sulfonate) powder     X      
Lexiva (fosamprenavir calcium) tablets and oral suspension     X X X PPI
Neoral (cyclosporine capsules, modified) soft gelatin capsule and oral solution     X X X  
Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system     X      
Pre-Pen (benzylpenicilloyl polylysine) injection     X X    
Sustiva (efavirenz) capsules and tablets     X X   PPI
Ultracet (tramadol HCl/acetaminophen) tablets     X X    
Ultram (tramadol hydrochloride) tablets     X X    
Voltaren Gel (diclofenac sodium) 1% topical gel     X      
Zolinza (vorinostat) capsules     X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Accupril (quinapril hydrochloride) tablets       X    
Accuretic (quinapril hydrochloride/ hydrochlorothiazide) tablets       X    
Arthrotec (diclofenac sodium/misoprostol) oral tablets       X X  
Asacol (mesalamine) 400 mg delayed-release tablets       X    
Cytotec (misoprostol) tablets       X X  
DepoDur (morphine sulfate extended-release) liposome injection       X    
Doral (quazepam) 7.5 mg and 15 mg oral tablets       X    
Lovaza (omega-3-acid ethyl esters) capsules       X    
Lozol (indapamide) 1.25 and 2.5mg tablets       X    
Malarone (atovaquone and proguanil hydrochloride) tablets       X    
Maxipime (cefepime hydrochloride) 500 mg, 1g, 2g per vial powder for injection       X    
OxyContin (oxycodone hydrochloride) controlled-release tablets       X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Zantac (ranitidine hydrochloride)        
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Actos (pioglitazone hydrochloride) tablet           MG
Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) and Actoplus Met XR (extended release) tablets           MG
Darvon (propoxyphene hydrochloride) capsules, Darvon-N (propoxyphene napsylate) tablets, and Darvocet-N (propoxyphene napsylate and acetaminophen) tablets           REMS
Duetact (pioglitazone HCl plus glimepiride fixed-dose combination) tablets           MG
Prilosec OTC (omeprazole magnesium) 20 mg delayed-release tablets           PI
Reglan (metoclopramide) tablets           REMS/MG

Vagistat-1  [OTC]

Vaginal Ointment (300 mg, 6.5%, tioconazole) and 1-Day Ointment (300 mg, 6.5% tioconazole)

          PI