Avandia Study May End Early Due to High Risk of Patient Heart Attack

By April 28, 2010Dangerous Drugs

In February, I wrote about the Senate’s report on their investigation of the diabetes drug Avandia (rosiglitazone) and allegedly unethical behavior by the drug’s manufacturer, GlaxoSmithKline. As a dangerous prescription drug lawyer, I keep a close watch when drug manufacturers face allegations of unethical behavior, as does GlaxoSmithKline, the maker of Avandia. Now, a Reuters report reveals that the FDA is considering ending a study of Avandia’s safety earlier than planned because subjecting study participants to this drug’s substantial risk of causing heart attack could be unethical.
A 2007 study by Dr. Steven Nissen of the Cleveland Clinic, published in the New England Journal of Medicine, showed that taking Avandia increased a patient’s heart attack risk by 64%. This is a frightening risk for Type II diabetes patients already at high risk for heart attack. University of Washington researcher Bruce M. Psaty, MD, PhD, said, “There is little evidence for using this drug…. The purpose of reducing blood sugar is to prevent cardiovascular events. Now the possibility of cardiovascular benefit associated with Avandia appears remote — indeed, it appears linked to harm.” Avandia already carries a black box warning, the strongest kind of warning from the FDA, about patients’ increased risk of heart failure. Two FDA drug safety reviewers recommended pulling the drug from the U.S. market in 2008, and in late March 2010, Saudi Arabia’s Food and Drug Authority suspended Avandia for six months.
Meanwhile, GlaxoSmithKline maintains that the evidence does not establish that Avandia increases the risk of heart attack, citing its own long-term study, which of course may not be completely objective. The February Senate report alleged that GlaxoSmithKline also tried to quash information damaging to Avandia by intimidating doctors and downplaying evidence of its dangers. Yet the Senate investigation found that privately, GlaxoSmithKline’s own scientists acknowledged that Dr. Nissen’s study was sound. As a defective prescription drug attorney, I think it’s important that patients be made aware of scientists’ and regulators’ concerns about Avandia.
By refusing to acknowledge the concerns of the FDA and the Senate, GlaxoSmithKline may be trying to protect its sales of Avandia, which reached $2.8 billion in 2006. But GlaxoSmithKline may pay a big price for doing so. Drug manufacturers can be held legally responsible for the harmful effects of their drugs if they fail to warn the public and government regulators about them. The FDA’s decision to consider ending the current Avandia study because of the heart attack risk, along with the Saudia Arabian FDA’s suspension of Avandia, suggests that everyone is convinced of Avandia’s risks — but GlaxoSmithKline simply won’t acknowledge them until it’s forced to. This is a dangerous game to play with patients’ health and lives.


Patients who are harmed by dangerous prescription drugs do not have to suffer in silence. Ongoing cardiovascular problems and diabetes require expensive and exhausting medical treatment, and patients whose problems were created or exacerbated by defective prescription drugs they trusted should not have to bear the costs alone. The law allows patients and families who have been hurt by such drugs to sue drug manufacturers for failing to warn of the drug’s risks, and make them pay for the harm they have caused. Patients and families can recover the costs of medical treatments, past and future lost income, and compensation for pain, suffering, and lost quality of life. A knowledgeable pharmaceutical liability lawyer can help patients claim these and other damages from the irresponsible pharmaceutical company that caused them.
The legal specialists at the Lowe Law Firm offer free consultations for patients and families who have been harmed by a prescription drug. To learn more, please call us toll-free at 1-877-678-3400 or contact us through our website.