Avandia Linked To Increase In Heart Attacks
The FDA issued the safety alert urging users to talk with their doctors, but fell short of pulling Avandia off the market. A recent article published in the New England Journal of Medicine showed the results of many tests and concluded that those taking Avandia had a 43% greater chance of having a heart attack than those not on the drug.
The drug came on the market approximately eight years ago and a reported six million people have prescribed to it. Avandia is prescribed to those with type 2 diabetes, the most common form of diabetes that affects nearly 18 million Americans and 200 million people worldwide.
Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Type 2 diabetes occurs when the body cannot make enough insulin or effectively use the insulin that the body can make. Insulin assists the body metabolize sugar for energy and Avandia was created to help the body maintain adequate blood sugar control.
Experts blame the manufacturer and the FDA
Its manufacturer, GlaxoSmithKline PLC, has been accused of not doing enough research on Avandia, and some of its other drugs such as Advair, which is prescribed for asthma, before bringing them to market. Likewise, many are blaming the FDA for not doing enough testing on the drug to completely understand the possible dangers now linked to Avandia. Congress is expected to conduct meetings on the FDA's apparent failure to recognize risks in drugs before they enter the market.
Interestingly, this recent report on Avandia followed GlaxoSmithKline's $2.5 million settlement of a lawsuit brought by now New York governor Eliot Spitzer which accused the company of fraudulently withholding information on the safety and effectiveness of its drugs. GlaxoSmithKline denied the charges even though it settled the lawsuit.
What to do if you take Avandia
According to the FDA, patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack, should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.
The Director of the FDA's Center for Drug Evaluation and Research, Dr. Steven Galson, reported that, "[The] FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia. We will complete our analyses and make the results available as soon as possible. [The] FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened."
Users should know that there are other drugs on the market that treat type 2 diabetes that have not been known to increase heart disease. Talk to your doctor about other options that might be available to you.
If you've had a heart attack while on Avandia, contact an attorney whose practice focuses in this area to discuss possible litigation against the company. To find an attorney near you, click here.