Avandia and diabetes patients have had a strained relationship since its release in 1999. A rosiglitazone drug, Avandia is manufactured by GlaxoSmithKline, and was developed for the treatment of type 2 diabetes by reducing insulin resistance in the body. Once the biggest selling diabetes drug in the world it was normally prescribed to taken in addition to other drugs such a metformin. According to a New York Times article, a study from 1999 to 2009 found more than 47,000 patients taking Avandia either suffered from a heart attack, stroke, heart failure, or death.
Avandia and Diabetes – Risk of Heart Attack
Numerous studies have been conducted on the increased risk of heart failure in patients who use Avandia. Numerous lawsuits have been filed against GlaxoSmithKline, resulting in the forced release of clinical studies on the drug. Following the studies release, Dr. Steven Nissen of the Cleveland Clinic began to analyze the data and published a separate study. Dr. Nissen published his findings in the New England Journal of Medicine in May of 2007, concluding that Avandia increased the risk of myocardial infarction by 40% (http://www.nejm.org/doi/full/10.1056/NEJMoa072761). Despite these findings the FDA ruled that the evidence was insufficient to take Avandia off the market, adding a more detailed warning to the label.
A report conducted by the European Commission on Human Medication (CHM) found that the possible benefits of rosiglitazones did not outweigh the risks posed to all parts of the population. The European study examined the risk of heart disease, comparing rosiglitazone, pioglitazone, and a placebo. On September 23, 2010 the European Medicines Agency banned Avandia and other drugs containing rosiglitazone due to the risks associated with them.
The FDA, Avandia, and Diabetes
In 2011 the FDA took action against Avandia, limiting the availability of the drug to only patients who have successfully been using it, tried other drugs to no effect, or do not wish to take pioglitazone. After November 2011 Avandia was taken out of pharmacies, and is only available by mail order. Avandia is only available through the Avandia-Rosiglitazone Medicines Access Program, which both patients and doctors must enroll in. Doctors must indicate that they fully understand the risks involved in prescribing Avandia and are committed to educating their patients.
The controversy over Avandia led the FDA to change it’s policy on diabetes medications in 2008, changing the old standard of approving medications simply because they lowered blood sugar levels. The new standard requires drug makers to conduct clinical trials for at least two years, proving that they pose no risk to the heart and improve overall quality of life of the patient.
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