Label Changes for:
Accolate (zafirlukast) tablets
August 2011
Changes have been made to the CONTRAINDICATIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –
August 2011
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
PATIENT PACKAGE INSERT
- new patient information
July 2010
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
