NEWS: July 24, 2008.

The  FDA on Thursday posts an advisory for physicians to conduct genetic testing before prescribing GlaxoSmithKline’s antiretroviral drug abacavir to reduce allergic reactions in people taking the drug. A recommendation to conduct genetic screenings will be included in a black box warning on the drug’s label. 

It was noted that any HIV-positive persons who have a particular variation in an immune system gene should not take Abacavir due to a higher risk of severe allergic reaction to the drug, according to FDA.

The FDA Abacavir Warning: 

Abacavir (marketed as Ziagen) and Abacavir-containing Medications

Audience: Infectious disease and medical genetics healthcare professionals

FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701.
FDA reviewed data from two studies that support a recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects.
Genetic tests for HLA-B*5701 are available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701.
Read the complete MedWatch 2008 Safety Summary, including a link to the Information for Healthcare Professionals document, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Abacavir

If you’ve been hurt or injured a Abacavir Lawsuit may be in order.  Please visit this lawyer and attorney website for more information.