New findings that show users of the diabetes drug Avandia have more than double the risk of a heart attack compared with other diabetes drugs is most significant. A recent study by Harvard researchers, slated for publication by the American Diabetes Association, found twice the number of heart attacks among 26,375 diabetic patients studied between 2000 and 2006 who took Avandia, compared with diabetic patients in the same time period who took a different oral diabetic medication. A separate study sponsored by GlaxoSmithKline – the manufacturer of Avandia – and i3 Drug Safety, an independent drug safety firm, found that Avandia users have a 35% to 41% increased risk of heart attack over users of Actos, Avandia’s main competitor.

The Harvard group analyzed clinical care data taken from the electronic medical records of patients at several Boston area hospitals and clinics associated with Harvard Medical School. All 26,375 patients’ records reviewed included a diagnosis of diabetes and the use of at least one oral diabetic medication used between the years 2000 and 2006. The researchers then reviewed the records to find all patients who suffered “myocardial infarction” or heart attack. The incidence of heart attack was more than double for Avandia compared with its main competitor Actos.

The GlaxoSmithKline-i3 study analyzed health insurance data from July of 2000 through March of 2007 for two groups of 47,501 subjects each. One group used Avandia and the other Actos. The GlaxoSmithKline-i3 study is slated for publication in the journal Clinical Therapeutics. These two studies – and especially the one by the Harvard group –adds to the overwhelming evidence that Avandia causes heart attacks in an already vulnerable population.

About 13,000 former Avandia users who have suffered heart attacks and other serious injuries have filed suit against GlaxoSmithKline in state and federal courts. The lawsuits accuse GlaxoSmithKline of aggressively marketing Avandia and failing to warn patients about the increased risk of heart attacks, heart failure and strokes. More than 500 federal suits have been consolidated in multi-district litigation in the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia.

Sales of Avandia, introduced in 1999, have declined in the wake of studies showing an increased risk of heart attacks, heart failure, liver diseases, bone fractures, anemia and macular edema, a swelling of the retina that can cause blindness. The Food and Drug Administration requires Avandia to carry a “black box” warning about potential increased risk of heart attack, but has resisted efforts by health experts and the consumer group Public Citizen to pull the drug off the market.

Source: Lawyers USA Online