Word: avandia
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Dates: during 2000-2009
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...eventual resignation of the CEO and fierce criticism of the Food and Drug Administration for failing to identify the risks of the drug before it was approved. Now a study released by the New England Journal of Medicine has linked one of the most commonly prescribed diabetes drugs, Avandia, to a significant increase in the risk of heart attack. But both the FDA and Avandia's manufacturer, the British pharmaceutical giant GlaxoSmithKline, are moving quickly to try to avoid being engulfed in a similar debacle...
...Renowned heart scientist Dr. Steven Nissen of the Cleveland Clinic, lead author of the study, analyzed what happened to 15,560 patients who were given Avandia and 12,283 in a control group. Using data from already published studies, Nissen found 86 myocardial infarctions in the group that took rosiglitzone, the chemical name for Avandia, compared with 72 in the control group. The number of deaths from heart disease was also higher - 39 among people who took the drug, compared to 22 for the control group. A few dozen deaths out of more than 15,000 subjects may seem small...
...Nissen acknowledges the limitations of his data, but writes that because the drug is so widely used, and because this population is so vulnerable to heart disease, anything that increases their risk of heart attacks is "worrisome" and warrants further study. Nissen tells TIME that he started looking into Avandia because he was concerned by the data in two of the largest studies of patients taking the drug. "The cardiovascular events were all going the wrong direction," he says. Though the results weren't statistically significant, they pushed him to look at other data sets, including studies...
...rosiglitazone at this time is unclear." The cardiovascular risks simply outweigh any benefit the drug appears to give in treating diabetes, the editorial says, and the FDA should now take regulatory action. With more than 1.5 million new cases of Type 2 diabetes each year in the U.S. and Avandia a mainstay in their treatment, 60 million prescriptions have been written since the drug was introduced...
...adjust your dose. Don't be surprised if you're not put on one of the new alternatives. There are several older medications that doctors rely on to treat Type 2 diabetes. "I personally have been very cautious about prescribing the new drugs," Nathan says. Besides, Actos and Avandia also require precautionary liver tests...