FDA clears GSK HIV med of increased heart risk

Initial data suggesting GlaxoSmithKline's HIV drug abacavir might raise a patient's risk of having a heart attack haven't borne out under further study, the FDA says in a determination that contradicts some previous studies. Despite "conflicting data" on the drug, doctors should keep prescribing abacavir products, the agency said.

The FDA has been reviewing safety information on abacavir, which is an ingredient in the anti-HIV products Ziagen, Trizivir and Epzicom, all now sold by ViiV Healthcare, the HIV joint venture between GSK and Pfizer. The agency took a look at 26 clinical trials and found that, on balance, abacavir didn't boost heart attack risks any more than other HIV treatments did, officials said.

Several observational studies and one clinical trial had identified an increased risk of heart attack in abacavir patients, but other studies didn't show similar results. GSK's own safety database also didn't turn up evidence of heart attack risk, the agency said in a statement. The nitty-gritty numbers are available in a meta-analysis FDA presented at a recent HIV treatment conference.

- see the report from the FDA
- read the Reuters news
- get more from Bloomberg
- check out an abstract on the FDA study