FDA To Recommend That Doctors Conduct Genetic Screening Before Prescribing Antiretroviral Abacavir To Reduce Allergic Reactions
Jul 29th, 2008 | By acca | Category: allergyFDA on Thursday is expected to issue an advisory that urges physicians to conduct genetic testing before prescribing GlaxoSmithKline’s antiretroviral drug abacavir to reduce allergic reactions in people taking the drug, the New York Times reports. The recommendation to conduct genetic screenings will be included in a black box warning on the drug’s label.
HIV-positive people who have a certain variation in an immune system gene should not take abacavir because they have a higher risk of a severe allergic reaction to the drug, according to FDA. A GSK-sponsored study, published in the New England Journal of Medicine in February, found that genetic screening prior to prescribing abacavir could reduce the incidence of suspected hypersensitivity reactions from 7.8% to 3.4%. Symptoms of the reaction include fever, rash, nausea and breathing difficulties. Based on the data, it was estimated that about 61% of people with the genetic variant could experience a severe allergic reaction to abacavir, compared with 4% of people without the variant.


