By Stuart Brown – 12th Oct 2015
Avandia (rosiglitazone) is a drug that has been licensed by the FDA since 1999 for the treatment of type 2 diabetes. Its use was severely restricted in Sept 2010 after the FDA linked it to a greater risk of strokes and heart attacks. Many of these restrictions were later removed in Nov 2013.
It is nevertheless instructive to take a closer look at how the original conclusions were arrived at.
The original decision in September 2010 came following a meeting of the FDA Advisory Committee in July 2010. Even at the time, it is interesting to note that the members of the committee were roughly evenly divided between:
- Basically changing nothing.
- Making some labelling changes and restricting its prescription.
- Ordering a withdrawal.
We can’t be sure of the exact numbers (the minutes of the meeting don’t say). However, we do know that option two was acted upon.
The decision in Sept 2010 followed what seemed like mounting evidence that Avandia caused heart attacks. For example, the New England Journal of Medicine published a paper in June 2007 by Dr. Steven Nissen that concluded:
“Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance.“
In raw percentages, it claimed that the risk of heart attack was raised by 43% by taking Avandia.
This was not an isolated study.
A 2007 paper published in The Journal of the American Medical Association concluded:
“Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure…”
Since that period, there have been a constant barrage of legal cases against GlaxoSmithKline, who make Avandia, with most being settled out of court. In May 2010, they paid around $60 million to settle 700 lawsuits. In July 2010, they agreed a payment of $460 million to settle 10,000 lawsuits and another of $250 million to settle 5,000 lawsuits in Feb 2011.
Avandia was also mentioned by the FDA in two contexts in the Press Release they put out in July 2013, when GlaxoSmithKline agreed to pay $3 billion in fines to the U.S Justice Department.
“Between 2001 and 2007, GSK failed to include certain safety data about Avandia…in reports to the FDA” …
And.
“That GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile.”
The Nov 2013 reversal of restrictions followed an FDA review of the data that showed that the risk from Avandia, “did not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea.”
It is interesting to note that this is not saying that there isn’t a risk. Only that the risk is comparable to other drugs used to treat type 2 diabetes. In fact, to muddy the waters they go on to say, “some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines still remains“.
It seems as though is it still very much a case of “watch this space” when looking at how the story of Avandia and Heart Attacks may develop in the future.