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U.S. Department of Health and Human Services

Safety

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Effient (prasugrel hydrochloride) 5 mg and 10 mg Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

 

November 2012

Summary View

WARNINGS AND PRECAUTIONS

General Risk of Bleeding
  • Propensity to bleed ….or moderate to severe renal impairment

 

 

September 2011 

Summary View

WARNINGS AND PRECAUTIONS

Hypersensitivity Including Angioedema
  • Hypersensitivity including angioedema has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other thienopyridines

PATIENT COUNSELING INFORMATION

Other Signs and Symptoms Requiring Medical Attention
  • Inform patients that they may have hypersensitivity reactions including rash, angioedema, anaphylaxis, or other manifestations. Patients who have had hypersensitivity reactions to other thienopyridines may have hypersensitivity reactions to Effient.

MEDICATION GUIDE

  • editorial changes throughout Medication Guide

 

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