Accolate®

Since ACCOLATE® was cleared by the FDA in September 1996, it has been prescribed to approximately 250,000 patients in the United States for the prophylaxis and chronic treatment of asthma in patients 12 years and older. Since April of 1997, the Accolate® labeling has contained a precaution stating that "if clinical signs or symptoms of liver dysfunction (e.g. right upper quadrant abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, and flu-like symptoms) are noted, it is reasonable to recommend that standard liver tests be obtained and the patient managed accordingly". Based on continued monitoring of post-marketing reports of liver dysfunction, the label has been revised to include more specific recommendations for patient management including the following:

If liver dysfunction is suspected based upon clinical signs of symptoms. Accolate® should be discontinued. Liver function tests, in particular serum ALT, should be measured immediately and the patient managed accordingly.

If liver function tests are consistent with hepatic dysfunction, Accolate® therapy should not be resumed.

Patients in whom Accolate® was withdrawn because of hepatic dysfunction, where no other attributable course is identified should not be re-exposed to Accolate®.

Hepatic events have occurred predominately in females.

Source: fda.gov

If you or a loved one has been harmed by Accolate®, you may want to contact an Accolate® attorney for more information.