Important Drug Warning: Severe Hypersensitivity Reactions Following Reintroduction with Ziagen® (Abacavir Sulfate) Products
Note: This is the retyped text of a letter from Glaxo Wellcome Inc. Contact the company for a copy of any referenced enclosures.
Glaxo Wellcome Inc. is writing to inform you of important new safety information about hypersensitivity reactions to abacavir, a nucleoside analogue reverse transcriptase inhibitor which, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection. Fatal hypersensitivity reactions are a described risk associated with the use of abacavir (Ziagen); patients who have developed hypersensitivity reactions upon abacavir rechallenge are at an increased risk of a severe hypersensitivity reaction, which may result in death.
Recent reports indicate that severe or fatal hypersensitivity reactions can occur within hours after Ziagen reintroduction in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy. In these reports:
If abacavir has been discontinued for reasons other than symptoms of hypersensitivity, and if reinitiation of Ziagen therapy is under consideration:
Please read the enclosed package insert for revisions in the BOXED WARNING, WARNINGS ADVERSE REACTIONS, PRECAUTIONS: Information for Patients and patient Medication Guide. This information is provided to help you in the management of patients prescribed Ziagen Tablets or Ziagen Oral Solution.
Glaxo Wellcome is committed to providing you with the current product information for the management of your patients being treated with Ziagen. You can assist us in monitoring the safety of Ziagen by reporting adverse reactions to the Glaxo Wellcome Product Surveillance Department at 1-888-825-5249 or to the FDA MedWatch program by telephone at 1-800-332-1088, by FAX at 1-800-332-0178, via www.fda.gov/medwatch, or by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20857.
Please refer to the enclosed revised prescribing information for Ziagen. If you have questions about the new information or want additional medical information about Ziagen, please contact the Glaxo Wellcome Customer Response Center at 1-888-TALK2GW (1-888-825-5249).
Marc Rubin, M.D.
Glaxo Wellcome Inc.
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