At one time, the diabetes medication Avandia was a top-selling prescription drug, totaling more than $3 billion in sales in the eight years after it was approved by the Food and Drug Administration (FDA). When a cardiologist published study results in 2007 linking Avandia to a greatly increased risk of heart attack, sales plummeted.
In 2010, Avandia—generic name rosiglitazone—was removed from the market in Europe, and the United States severely restricted its use, limiting prescriptions to people who are seriously ill with diabetes—so ill that the tradeoff of an effective drug for an increased risk of heart attack is acceptable. Now, after a meeting of federal health advisors to the FDA, it seems that Avandia will be made more available once again.
The Original Decision
An article in The New York Times relates how Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, questioned the safety of Avandia in 2007 after reviewing more than 50 studies of patients who used the drug. According to Nissen, the results showed an elevated risk of heart attack in Avandia users—in one study, more than 47,000 cases of heart attack, stroke, or heart failure. Nissen asserted that Avandia was too dangerous for diabetic patients to use.
In 2010, Dr. Janet Woodcock of the FDA ordered an outside review of a clinical trial done by GlaxoSmithKline, Avandia’s manufacturer. Because of a Senate inquiry stemming from the controversy, drug manufacturers are now required to prove that new diabetes drugs do not cause risk to the heart.
The FDA Reconsiders
According to CNBC, Dr. Woodcock stated that the purpose of the meeting on June 5 and 6 was to go over the results of the review, which was performed by Duke University. The review upheld the manufacturer’s initial findings that Avandia presented no significant risk of heart problems.
Half of the panel of 26 health experts voted for current restrictions on Avandia to be relaxed; seven wanted the restrictions lifted completely; five thought the restrictions should not be changed, and one believed that Avandia should be taken off the market.
Dr. William Hiatt, a cardiologist from the University of Colorado, was one of the seven who wanted to get rid of the restrictions. “In general,” he said, “this drug doesn’t look any different than any other diabetes drug.”
New Clinical Trials Are Unlikely
Some of the committee members suggested running a new clinical trial to determine Avandia’s risk to heart health, but other members considered this an exercise in futility. All of the negative publicity surrounding Avandia, they say, had to have squelched interest in funding any more research on the drug.
Dr. Kenneth Burman of the Washington Hospital Center joined other committee members in supporting the idea of forming a registry of Avandia users. In this way, patients’ health could be monitored, in light of concerns about heart attack.
Because of the increasing obesity problem today and the health problems it can cause, including Type-2 diabetes, experts object to eliminating Avandia as an option for treating diabetes. “When treating diabetes we really do need drugs that lower blood sugar without causing hypoglycemia,” said Dr. Ellen Seely of Harvard Medical School, “and there’s not a lot that’s available.”
If someone you love has died as a result of complications from Avandia or any other medication, get a knowledgeable Louisville wrongful death attorney. Call Gray and White Law in Louisville at 502-210-8942 or toll-free at 888-450-4456. We’ll set up a FREE, no-obligation consultation to discuss your case.