January 1999

Dear Health Care Professional:

Glaxo Wellcome Inc. would like to bring to your attention recent changes to the enclosed package inserts for FLOVENT (fluticasone propionate) Inhalation Aerosol and FLOVENT ROTADISK (fluticasone propionate inhalation powder). FLOVENT Inhalation Aerosol was approved by the FDA in March 1996 and FLOVENT ROTADISK was approved in November 1997 for the maintenance treatment of asthma as prophylactic therapy.

As part of the Glaxo Wellcome drug surveillance program, the company has become aware of rare case reports in which patients receiving FLOVENT as part of their asthma management plan presented with systemic eosinophilia, with some patients exhibiting clinical features of vasculitis consistent with Churg-Strauss syndrome. Most of these reports involved patients with severe asthma and in the majority of cases the events were preceded by the reduction or stopping of oral corticosteroid therapy. A casual relationship with FLOVENT has not been established. Cases of serious eosinophilic conditions also have been reported with other inhaled corticosteroids in this clinical setting. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.

In order to communicate this important information to health care professionals, the PRECAUTIONS and ADVERSE REACTIONS sections of the package inserts for these products have been revised to include the following changes

Eosinophilic Conditions: In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions, with some patients presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of fluticasone propionate. Cases of serious eosinophilic conditions have also been reported with other inhaled corticosteroids in this clinical setting. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal relationship between fluticasone propionate and these underlying conditions has not been established.

These changes to the package insert are being made voluntarily based on reports received during marketed use of FLOVENT by approximately 4 million patients worldwide since its first approval in the United Kingdom in March 1993.

Any questions from health care professionals may be directed to our Drug Information Department at 1-800-334-0089

You can also assist us in monitoring the safety of FLOVENT Inhalation Aerosol and FLOVENT ROTADISK by reporting all adverse events to Glaxo Wellcome Product Surveillance at 1-888-825-5249 (extension 3-7070) or to the FDA MEDWATCH program by phone 1-800-FDA-1088, by FAX at 1-800-FDA-0178, via the MEDWATCH Web site at www.fda.gov/medwatch, or by mail at MEDWATCH, HF-2, 5600 Fishers Lane, Rockville, MD 20857.

Sincerely,

David A. Boyko, M.D.
Vice President, U.S. Medical Affairs

Enclosures