Earlier this summer, two independent studies confirmed that diabetes drug, Avandia, increases the likelihood of heart attack and bolstered claims that the side effect risks of the drug outweigh its benefits to patients with Type 2 diabetes.
The two studies – one published in the Journal of the American Medical Association and another published in the Archives of Internal Medicine – showed that Avandia increased the risk of heart attack, stroke, heart failure, and a general increased risk of death when compared to other similar medication. Reports estimate as many as 100,000 heart attack and stroke deaths have been caused by Avandia since 1999.
According to the US Food and Drug Administration (FDA), there is "a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia." Data given to the FDA by GlaxoSmithKline suggest a 30-40% increase in the risk of heart attacks and other heart-related deaths. In November 2007, the FDA mandated that a "black box warning" be included on Avandia packaging to warn of increased risk of heart attacks and heart-related chest pain.
The national, non-profit consumer advocacy group Public Citizen has identified 14 cases of Avandia-induced liver failure, which resulted in 12 deaths. The cases were discovered through the FDA Adverse Event Reporting System, which collects information on dangerous drug reactions. "The scientific consensus against Avandia is overwhelming," said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. "The timing of these findings should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug."
A study conducted by Swiss researchers has found a correlation between Avandia use and bone fractures. The Swiss study looked at medical records of more than 1,000 patients who used Avandia and suffered broken bones between 1994-2005. They found that there was a significant increase in patients suffering broken bones when taking Avandia compared to diabetic patients not taking the drug.
In July, the Food and Drug Administration (FDA) held a two-day hearing to further assess the risks and side effect dangers of Avandia.
In September, drug regulators in Europe coordinated with the FDA in the U.S. to announce that Avandia would no longer be widely available because of these serious side effect risks. Following the announcement, Avandia will not be permitted at all in Europe and US patients will be allowed access to the drug only as a last resort. Both the patient and his/her doctor must attest they have tried every other diabetes medication and that patients have been made aware of the drug’s substantial heart risks.
From the NY Times:
Dr. Steven Nissen, a Cleveland Clinic cardiologist whose studies highlighted Avandia’s heart attack risks, said that the decision brought an end to “one of the worst drug safety tragedies in our lifetime,” adding that it was “essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future.”
Despite years of studies showing significant side effect dangers, drug maker GlaxoSmithKline continued to push sales of Avandia to the public. In fact, the company went into "full tilt spin mode" and even attempted to conceal Avandia’s risks.
As Dr. Nissen has said, GlaxoSmithKline should have "put patients first", not profits first.
(c) Copyright 2010 Brett A. Emison
Brett Emison is currently a partner at Langdon & Emison, a firm dedicated to helping injured victims across the country from their primary office near Kansas City. Mainly focusing on catastrophic injury and death cases as well as complex mass tort and dangerous drug cases, Mr. Emison often deals with automotive defects, automobile crashes, railroad crossing accidents (train accidents), trucking accidents, dangerous and defective drugs, defective medical devices.