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Accolate (zafirlukast) Dear Healthcare Professional Letter Sep 2000

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.


This is the retyped text of a letter from Astra Zeneca Company. Contact the company for a copy of any referenced enclosures.

September 2000

Dear Health Care Provider:

As part of its commitment to the medical community, AstraZeneca maintains a current database on all postmarketing reports for its prescribed medications. These reports are analyzed regularly and updates to labels are made when appropriate. Accolate® (zafirlukast), a leukotriene receptor antagonist indicated for the prophylaxis and chronic treatment of asthma in adults and children 7 years of age and older, has been prescribed with increased frequency over the past three years. With this increased usage, additional events have been reported in association with Accolate use. Therefore, AstraZeneca wishes to advise you of revisions to the PRECAUTIONS and ADVERSE REACTIONS sections in the labeling for Accolate. The changes are contained in the enclosed package insert. The principal changes are as follows:

PRECAUTIONS-Hepatic Dysfunction
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 accordinly". Based on continued monitoring of postmarketing 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  • Patients in whom Accolate was withdrawn because of hepatic dysfunction, where no other attributable course is identified should not be re-exposed to Accolate.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.

PRECAUTIONS-Geriatrics Use
This section is revised according to the FDA Final Rule on August 27, 1997 for all prescription drug products. The approved product labeling for Accolate has been revised to include the following information.

  • No overall differences in adverse events was seen in the elderly patients, except for an increase in the frequency of infections among zafirlukast-treated elderly patients compared to placebo-treated elderly patients (7% vs 2.9%).
  • In an open-label, uncontrolled, 4-week trial of 3,759 asthma patients comparing the safety and efficacy of Accolate 20 mg given twice daily in three patient age groups, a higher percentage of elderly patients, when compared to adults and adolescents, reported adverse events. These elderly patients showed less improvement in efficacy measures. The elderly reported the lowest percentage of infections of all three age groups in this study.

In addition to changes regarding hepatic dysfunction as described above, the ADVERSE REACTIONS section of the Accolate labeling has been revised to include the following information:

  • There have been reports of patients experiencing arthralgia and myalgia in association with Accolate therapy.

Adverse Event Reporting
AstraZeneca requests that all adverse events occurring in patients treated with Accolate be reported to AstraZeneca at 302-886-8000 and the FDA via MEDWATCH by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MEDWATCH, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20857, or on the MEDWATCH website at www.fda.gov/medwatch.

Physicians Desk Reference is sending you the enclosed Addendum containing complete prescribing information for Accolate. This revised prescribing information should be included in the AstraZeneca section of your 2000 PDR on page 535.

Be sure to include this important revised prescribing information to ensure that your 2000 PDR is correct and up to date.


Mukesh Mehta, RPh
Vice President, Clinical Communications & New Business Development
Physicians Desk Reference

1800 Concord Pike
P.O. Box 15437
Wilmington, DE 19850-5437
Phone: 302.886.3000
AstraZeneca Website