The FDA will keep Avandia on the market but limit it to type 2 diabetes patients who cannot control the disease on other drugs. Agency reviewers David Graham and Thomas Marciniak, and cardiologist Steven Nissen, had urged a ban, calling the rival drug Actos safer.
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Avandia
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Diet
Plant-based diet effective in treating diabetes, PCRM says
PCRM says it sued the FDA for failing to act on its petition asking the agency to point diabetes patients toward dietary alternatives on Avandia's label. The group cites a 2006 NIH-funded study that found a low-fat plant-based diet matched oral drugs at lowering blood sugar and cholesterol.
Drug
FDA Orders Glaxo to Stop an Avandia Trial
The FDA told GlaxoSmithKline on July 20 to stop enrolling new patients in a trial of the diabetes drug Avandia, while letting the study continue. Public Citizen's Sidney Wolfe called that going only halfway; an FDA advisory panel had voted 20 to 12 to keep the drug on the market.
Drug
Avandia linked to cardiovascular risk again
An FDA advisory panel split on Avandia: 12 of 33 members voted to withdraw it, 10 to keep it on the market and seven to add warnings. The FDA's David Graham presented findings that the drug raised heart attack, stroke, heart failure and death risk by 9%, 27%, 25% and 14%.
Drug
Both Avandia and Actos may raise fracture risk
Analyzing pharmacy and medical claims over 540 days, researchers found diabetes patients taking Avandia or Actos were 39 percent likelier to suffer a fracture than patients on neither drug, with comparable increases in men. The findings ran in Diabetes, Obesity & Metabolism.
Lifestyle
Avandia will stay on the market, but you don't have to take it
An FDA advisory panel voted 20 to 12 to keep Avandia on the market, though tougher label warnings may follow. The piece argues patients can ask for Actos instead, which cardiologist Steven Nissen and FDA reviewer David Graham say offers similar benefits far more safely.
Drug
FDA may not ban Avandia
FDA advisers meet July 13 and 14 to decide whether Avandia stays on the market. Agency reviewers disagree over the RECORD trial, with one calling it inadequately designed and saying the drug raises heart attack risk; cardiologist Steven Nissen will argue for withdrawal.
Drug
Could Diabetes drug Avandia escape this time?
Two FDA advisory committees met July 13 and 14 to weigh whether Avandia stays on the market. A Harvard meta-analysis of 42 studies covering 28,361 patients found death rates 15 percent higher and heart failure 13 percent higher than with Actos.
Diabetes
Avandia Coming Under Fire
Research in the Archives of Internal Medicine covering more than a quarter of a million Medicare patients found Avandia carried a 28 to 39 percent higher risk of major cardiovascular events, which researchers put at roughly one event per 60 patients treated for a year.
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