What the FDA Relabeling of Abacavir Means for You and Your Patient

FDA Caution and Relabeling

November 2008

In July 2008, the FDA alert came about on a review of studies linking potentially fatal hypersensitivity reactions with abacavir in relations to a specific HLA-B allele (HLA-B*5701). Testing of HIV infected patients for this allele is recommended prior to prescribing Abacavir. This information is now added to the box warning and product label for this drug.

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FDA Caution and Relabeling

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Jump to section:

• Introduction
• Highly Active Antiretroviral Therapy
• Abacavir
• FDA Caution and Relabeling
• Abacavir Hypersensitivity
• Abacavir HSR and HLA Gene
• HLA-B Antigens and Alleles
• Naming Conventions - HLA-B*5701
• Chromosome 6
• Detecting HLA Alleles
• HLA-B*5701 Correlations
• HLA-B*5701 Correlations
• Clinical Utility³
• Problems
• If HSR Symptoms are Present⁴
• If HSR Symptoms are Present⁴
• Recommendations for Physicians⁵
• Recommendations for Physicians⁵
• Information for Patients⁵
• Information for Patients⁵
• HLA-B*5701 Genotyping
• References
• Questions?