educating healthcare professionals and advancing public policy for the Alpha-1 Community.” 
|
|
One Baxter Parkway Deerfield, IL. 60015 Baxter January 14, 2005 Dear Alpha-1 Patient: You may have received a letter from the Alpha-1 Foundation dated January 11, 2005, regarding the safety of ARALAST brand of Alpha1-Proteinase Inhibitor (Human). We would like to address several misconceptions in the letter and assure you that ARALAST is a safe and effective product. The Alpha-1 Foundation's letter suggests that there have been modifications to the way ARALAST is made that may result in health risks. The fact is, there have been no changes to ARALAST or its safety profile and the ARALAST that is available today is the same product that was approved by the U.S. Food and Drug Administration in December 2002. It is important to note that there have been more than 7,000 infusions of ARALAST to date with no known reported serious adverse events. In addition, our experience with the product since it was made available to patients continues to be consistent with the results shown in clinical trials. At Baxter, we are confident and proud of the safety and efficacy of ARALAST. For more than 50 years, Baxter has provided critical therapies to patients with life-threatening conditions. We have a proven safety record and strive to provide patients with products of the highest quality. If you have any further questions please contact your physician or our Medical Affairs Department at 866-4-BIOSCI (866-424-6724). Regards 
David Gelmont, M.D. Global Medical Director, Pulmonary and Critical Care Therapeutic Area Please refer to Important Safety Information on the next page |
|
Baxter Important Safety Information: ARALAST is not indicated in therapy for lung disease patients in whom alpha-1 proteinase inhibitor deficiency has not been established. ARALAST is contraindicated in individuals with selective IgA deficiencies (IgA level less than 15mg/dL) who have known antibody against IgA, since they may experience severe reactions, including anaphylaxis, to IgA, which may be present. The most common symptoms during the clinical study were headache (0.3%) and somnolence (0.3%). Post market adverse event data have indicated reports infusion site pain associated with the administration of ARALAST. Pregnancy Category C, reproduction studies have not been conducted with ARALAST. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. Please see enclosed ARALAST full prescribing information. Please Click HERE for: Complete "AralastTM" Prescribing Information |
For more information about Baxter, please visit www.aralast.com
and is registered in the U.S. Patent and Trademark Office.
Copyright © 2005 Baxter Healthcare Corporation. All rights reserved 01/05.
Telephone: 540-948-6777 or 1-866-FOR-A1AA (1-866-367-2122) Fax # 540-948-6763
Copyright © 2005 Alpha-1 Advocacy Alliance, All Rights Reserved
Home | Disclaimer | Privacy Policy