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U.S. Department of Health and Human Services

Safety

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Accolate (zafirlukast) tablet

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

 

August 2011 

Summary View

 

CONTRAINDICATIONS

  • Accolate is contraindicated in patients with hepatic impairment including hepatic cirrhosis

 

PPI

Who should not take Accolate?
  • have problems with your liver

 

October 2010

Summary View

 

PATIENT PACKAGE INSERT

  • new patient information

 

July 2010

Summary View

 

PRECAUTIONS

Information for Patients
  • Eosinophilc Conditions: The possibility that Accolate may be associated with emergence of Churg-Strauss syndrome can neither be excluded nor established.

 

ADVERSE REACTIONS

Adults and Children 12 years of age and older
  • In rare cases, patients with asthma on Accolate may present with systemic eosinophilia, eosinophilic pneumonia, or clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic steroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. These events have usually, but not always, been associated with reductions and/or withdrawal of steroid therapy. The possibility that Accolate may be associated with emergence of Churg-Strauss syndrome can neither be excluded nor established