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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and the FDA held another advisory meeting in July 2010, where a majority of experts decided that Avandia should be withdrawn or its sales restricted, leading to today’s announcement.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.