Policy & Politics
FDA to Review Safety of GSK, BMS Antiretrovirals Abacavir, Didanosine
March 28, 2008
FDA on Thursday announced that it will review the safety of GlaxoSmithKline's antiretroviral drug abacavir and Bristol-Myers Squibb's antiretroviral didanosine, Reuters reports (Richwine, Reuters, 3/27). The agency said that data pooled from a recent study conducted among more than 33,000 HIV-positive people found that the antiretrovirals were linked to an increased risk of heart attack among some of the participants (AP/Wall Street Journal, 3/27).
Marc Meachem, a GSK spokesperson, said the company has analyzed its own databases and "did not see any sign of an increased risk of heart attack." BMS spokesperson Sonia Choi said that the company has not "seen an increase of cardiovascular events in our studies of VIDEX or in our (company) safety database." FDA said that the results from analyses by GSK and BMS are inconclusive, according to Reuters. Mark Schoenebaum, an analyst for Bear Stearns, said in a research note that he believes safety concerns with GSK's abacavir "will drive increased switching to Gilead-based regimens" (Reuters, 3/27).
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.