Avandia risks lead regulators to call for more testing of diabetes drugs
An FDA advisory panel recommended yesterday that diabetes drugs should be subjected to tougher standards before being approved, to protect patients from heart risks. The advisory opinion was sought by the FDA after they were subjected to intense criticism for not discovering Avandia risks that could increase the risk of heart attacks and death among diabetics.
>>INFORMATION: Avandia Heart Risks
About 24 million people in the United States have type 2 diabetes, and medications approved to treat the condition are some of the biggest selling drugs in the country. Type 2 diabetes is a serious medical condition which can can lead to blindness, kidney disease, loss of limbs and heart disease. Last year, the combined sales for diabetes drugs exceeded $6 billion in the United States.
Many diabetes drugs are approved on the basis that they lower blood sugar, since diabetics produce less insulin, which causes their blood sugar to rise. However, there is no evidence that lowering blood sugar reduces heart risks, which are the leading cause of death among diabetics.
The panel considered whether the FDA should require that diabetes drugs have a positive impact on heart disease and increase the life span. Experts testified before the panel that some diabetes drugs which have been shown to lower blood sugar, actually damage patients’ hearts. The panel recommended that the FDA require drug makers to face tougher safety standards for diabetes drugs to protect patients from these heart risks.
Concerns about the safety of diabetes drugs gained widespread attention in May 2007, when a study was published in the New England Journal of Medicine that found that Avandia side effects increase the risk of a heart attack by 43%. At that time, Avandia was being used by about 1 million Americans and generated sales in excess of $2.2 billion per year. Experts have estimated that Avandia heart risks could have caused nearly 100,000 heart attacks since it was approved.
AVANDIA HEART LAWSUITS
Thousands of Avandia users who suffered a heart attack or other heart damage are currently pursuing Avandia lawsuits as a result of the cardiovascular risks the manufacturer failed to warn about or properly research when they introduced the drug. The Avandia lawyers at Saiontz & Kirk, P.A. are reviewing potential cases throughout the United States for users of the diabetes drug who suffered a heart attack, stroke, congestive heart failure or death. To review a potential case, request a free consultation and claim evaluation.
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