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Avandia warning – consider other diabetes drugs

Wednesday, Nov. 14, 2007

New FDA Avandia Warning: Consumer Reports Urges Diabetics with Risk Factors for Heart Disease to Consider Other Medications

(Washington, D.C.) – While doctors and consumers await a new safety study ordered today by the FDA on the heart-attack risk of the type 2 diabetes drug Avandia, Consumer Reports Best Buy Drugs continues to advise against the use of the drug for people with diabetes who have other risk factors for heart disease, since safer medications are available.
“People with type 2 diabetes who have other risk factors for heart disease – and that’s most people with the condition — should avoid Avandia,” said Steven Findlay, managing editor of Consumer Reports Best Buy Drugs, a public education project that utilizes scientific evidence to identify safe, effective and affordable medications.
“As often as not in drug evaluation, where there’s smoke there’s is fire. Until further studies are completed that exonerate this drug, we urge most people with type 2 diabetes to find alternatives. Fortunately, several are available,” Findlay added.
A Consumer Reports Best Buy Drugs report on oral diabetes medicines discusses Avandia in the context of the various treatment choices people with type 2 diabetes face. The report, written for consumers and based on a systematic analysis of the evidence conducted for the Agency for Healthcare Research and Quality, can be obtained free at http://www.CRBestBuyDrugs.org.
The FDA today issued a black-box warning—the Agency’s strongest warning–on Avandia about the potential for an increased risk of heart attacks. The warning alerts people with type 2 diabetes who are taking Avandia and have underlying heart disease or who are at high risk of heart attack to talk with their healthcare provider. The agency also ordered the drug’s maker, GlaxoSmithKline, to conduct a new long-term study to evaluate the potential cardiovascular risk.
Recent studies show that about 47 percent of people with type 2 diabetes have two other risk factors (such as high blood pressure, smoking, and/or high cholesterol); and 18 percent had three of more risk factors. Obesity is also an independent risk factor for heightened risk of heart attack. About 55 percent of people diagnosed with type 2 diabetes in the U.S. are overweight or obese, and some studies put the percentage at close to 75 percent.
Consumers Union supports the FDA’s move to compel GSK to conduct a new safety study on Avandia, but notes that the results of such a study may not be available for years. CU urges the agency to immediately undertake a formal aggregation of data from large health insurance plans and Medicare to probe any relationship between Avandia and heart attack, help clarify the risk, and make those findings public as soon as possible.
The recently passed FDA reform legislation includes provisions and funding to conduct such analyses. It has been estimated that actively mining large health databases in the legislation could more quickly pick up safety problems in drugs on the market. For example, it has been estimated that Vioxx’s dangers would have been detected in about three months. Vioxx was removed from the market in 2004, several years after the first studies found it increased heart attack and stroke risk.
Concerns about Avandia’s heart attack risk first arose in 1999. A study published in May in the New England Journal of Medicine linked Avandia to a 43 percent increased risk of heart attack, prompting the latest review of the drug. The same day the article was published, the FDA issued a safety alert for the drug.
Avandia was recently restricted by regulators in Canada because of concern about the drug’s potential to damage the heart. Avandia can be used alone only in rare circumstances and shouldn’t be given in three-drug combinations, and patients with heart failure shouldn’t take it, the regulatory agency Health Canada said.
Contact: Susan Herold, Steve Findlay, 202-462-6262