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U.S. Department of Health and Human Services

Safety

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December 2013

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
Iclusig (ponatinib) tabletsX XX  
Tysabri (natalizumab) Injection 
X
  X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Hemabate (carboprost tromethamine) Sterile Solution Injection X  X 
Tikosyn (dofetilide) Capsules   X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Avastin (bevacizumab)   XX 
Benlysta (belimumab)   XX  
Canasa (mesalamine) Rectal Suppository   XX  

Concerta (methylphenidate HCl) Extended-Release Tablets 

*risk of increased erections or priapism

  XXXMG

Daytrana (methylphenidate transdermal system) 

*risk of increased erections or priapism

  XXXMG

Focalin (dexmethylphenidate) tablets and Focalin XR (Dexmethylphenidate Hydrochloride) extended-release tablets

*risk of increased erections or priapism

  XXXMG

Metadate CD (methylphenidate HCl) Extended-Release Capsules

*risk of increased erections or priapism

  XXXMG

Methylin (methylphenidate) Oral Solution and Chewable Tablets

*risk of increased erections or priapism

  XXXMG
Plavix (clopidogrel bisulfate) Tablets  XXX 

Quillivant XR (methylphenidate) extended-release oral suspension 

*risk of increased erections or priapism

  XXXMG
Ranexa (ranolazine) extended-release Tablets  XXX 

Ritalin (methylphenidate hydrochloride) Tablets, Ritalin SR (Sustained-Release Tablets, and Ritalin LA Extended-Release Capsules 

*risk of increased erections or priapism

  XXXMG
Taxotere (docetaxel) Injection Concentrate   XXXPI 
Yervoy (ipilimumab)  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Brilinta (ticagrelor) Tablets     X 
Pristiq (desvenlafaxine) Extended-Release Tablets     X 
Tafinlar (dabrafenib) Capsules     X 
Viibryd (vilazodone hydrochloride) tablets     X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Adderall XR (mixed amphetamine salts) capsules 

*risk of increased erections or priapism

    
X
 
Amyvid (Florbetapir F 18 Injection)    X 
Caverject Impulse Dual Chamber System (alprostadil for injection)     
X
 

Desoxyn (methamphetamine hydrochloride) tablets 

*risk of increased erections or priapism

    X 

Dexedrine (dextroamphetamine sulfate) Spansule sustained release capsules 

*risk of increased erections or priapism

    X 

Lamictal (lamotrigine) tablets, chewable dispersible tablets

Lamictal ODT (lamotrigine) orally disintegrating tablets

Lamictal XR (lamotrigine) extended-release tablets

    X 
Lialda (mesalamine) Delayed-Release Tablets    
X
 
Metastron (Strontium-89 Chloride) Injection    X 
MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution)    X 
Pentasa (mesalamine) Controlled-Release Capsules    X 
Pradaxa (dabigatran etexilate mesylate) Capsules    X 
Protonix (pantoprazole sodium) for Delayed-Release Suspension, and Delayed-Release Oral Tablets     X 
Protonix I.V. (pantoprazole sodium) for Injection     X 
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules     X 
Somavert (pegvisomant) injection     X 

Vyvanse (lisdexamfetamine dimesylate) capsules 

*risk of increased erections or priapism

    X 

Zofran (ondansetron hydrochloride) Tablets, Oral Solution, Injection

Zofran ODT (ondansetron) Orally Disintegrating Tablets

    X