FDA Dispels Concerns About Heart Attacks And HIV Drug

When the Food and Drug Administration raises an early warning flag about a drug, the bad news often piles up in a hurry.

But the agency has wrapped up a safety review of the HIV drug abacavir, suspected of raising the risk for heart attacks, and concluded the full body of evidence doesn't support the original concern.

The medicine is sold in pills with the brand names Ziagen, Trizivir and Epzicom.

The agency crunched data from 26 randomized controlled trials, the gold standard in clinical tests, and decided they didn't show an increased risk of heart attacks. An overview of the analysis, presented Monday at the Conference on Retroviruses and Opportunistic Infections, is here.

The analysis included information about nearly 10,000 people, about half taking abacavir and half not. Twenty-five people taking the medicine had heart attacks compared with 22 reported among those not on the drug.



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