FDA finds congestive heart failure in Avandia patients
The Director of the Diabetes Care Center at the University of North Carolina, Dr. John Buse, sent a letter to the U.S. Food and Drug Administration (FDA) in 2000 warning that SmithKline Beecham, the company that would later merge with Glaxo to become GSK, mishandled clinical trial data that that showed Avandia may increase a patient’s risk of heart attack by as much as 50 percent. Buse recently testified that GSK threatened him with a lawsuit after he criticized Avandia at a medical meeting (New York Times, June 7, 2007).
In 2002, according to consumer group Public Citizen, the FDA found 25 cases of Avandia patients who developed congestive heart failure while on Avandia. In most cases, the heart failure improved when the patient was taken off Avandia (Public Citizen, May 22, 2007).
Avandia may raise heart attack risk more than 40 percent
On May 21, 2007, a study by Dr. Steven Nissen of the Cleveland Clinic published in the New England Journal of Medicine found that the diabetes drug Avandia may raise a patient’s risk of heart attack by as much as 43 percent and the risk of death by heart attack or other cardiovascular event by 64 percent (New York Times, May 21, 2007). Within one day of the report, evidence came to light that the drug’s manufacturer, GlaxoSmithKline (GSK), may have known about the risks of its product as early as 2000. Did GSK fail to warn patients about the risks of taking Avandia? Why has there not been an Avandia recall in the United States?
Call an Avandia Lawyer Today – Free Call, No Obligation
If you or someone you love has been taking Avandia to control diabetes and have experienced high blood pressure, edema (swelling), congestive heart failure, heart attack, or other adverse cardiovascular events, the FDA is urging you to contact your healthcare provider to consider other options to control your diabetes. Contact our personal injury law firm today. A consultation with a product liability lawyer may be in your best interest. If GlaxoSmithKline knew that the risks of taking Avandia were more dangerous than it claimed, you may be entitled to compensation for the injuries you may have suffered as a result. Our lawyers are investigating the circumstances of these cases. Your information will be reviewed by a product liability lawyer who may be able to help you gain compensation from an Avandia lawsuit.
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