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September 23, 2010
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Glaxo Concealed Evidence on Avandia
Mother Jones (9/29). Paul D. Thacker discussed his time as lead investigator for Sen. Chuck Grassley on the Senate Finance Committee’s investigation into GlaxoSmithKline’s Avandia. “What emerged was a troubling picture of a company that had placed corporate profits over patient safety. While suppressing inconvenient evidence about the risks of its top-selling drug, the company even began to develop another drug to treat the very side effect Avandia has been linked to.”
GSK’s actions “reflect a consistent pattern of objectionable behavior,” said Steven Nissen, chairman of the cardiology department at the Cleveland Clinic and a drug safety champion. He adds: “Whenever the company developed evidence of harm from Avandia, they actively sought to conceal this information from physicians and patients. This pattern of deceit has resulted in serious injury or death in 50,000 to 200,000 patients.”
FDA Drug Safety Podcast
The FDA significantly restricted acess to the diabetes drug Avanda. FDA Safety Podcast 9.28.10
FDA Adds New Restrictions to Avandia
The Washington Post (9/24, A15, Stein) reported that Avandia (rosiglitazone) will be pulled from the European market and will be available in the United States only with restrictions. Patients will be permitted to take Avandia only if they are unable to control their blood sugar with other drugs. Doctors in the US who prescribe Avandia will require patients who take Avandia (rosiglitazone) to sign statements that they understand the risks. New information will be added to Avandia’s label to reflect these changes.
Drug Regulators in the US and Europe Restrict Use of Avandia (rosiglitazone)
NYTimes (9/23, Harris). Drug regulators in Europe and the US have restricted the use of Avandia (rosiglitazone), the diabetes medicine made by GlaxoSmithKline, due to an elevated risk of cardiovascular events, such as heart attack or stroke. Medwatch Avandia Safety Alert 9.23.10
Avandia will no longer be sold in Europe. Patients in the US will be permitted to receive Avandia only if they have tried every other diabetes medicine and have been made aware of the drug’s substantial risks to the heart.
Avandia was approved in 1999, and helps to control blood sugar levels by making patients more sensitive to their own insulin.
Avandia was once the biggest selling diabetes medication in the world, but its sales declined abruptly in 2007 following a study by Dr. Steven Nissen (a Cleveland Clinic cardiologist) that indicated that Avandia increased the risk of heart attack. Additional studies intensified the controversy and the FDA held another advisory meeting in July 2010, where a majority of experts decided that Avandia should be withdrawn or its sales restricted, leading to today’s announcement.
The FDA also ordered GlaxoSmithKline to conduct an independent assessment of the RECORD trial, a landmark study of Avandia’s cardiac effects. Senate investigators found that GlaxoSmithKline spent years hiding clear indications that Avandia increased heart risks from regulatory authorities.
If you or a family member have taken Avandia to treat diabetes and suffered from serious cardiac complications, such as heart attack or stroke, you may have a claim against the manufacturers of Avandia.
One of our experienced pharmaceutical attorneys would be pleased to assist you in seeking legal remedies. Please complete the short form below or call us at 1-800-642-5297 for a free, confidential consultation at a time convenient for you.