So it's worrisome that an analysis published in this week's New England Journal of Medicine (NEJM) concluded:
"Rosiglitazone [Avandia] was associated with a significant increase in the risk of myocardial infarction."GlaxoSmithKline, the maker of Avandia, had a swift response:
"GSK strongly disagrees with the conclusions reached in the NEJM article, which are based on incomplete evidence and a methodology that the author admits has significant limitations."
Avandia was approved by the FDA in 1999 for the treatment of type 2 diabetes. It is a member of a class of drugs known as thiazolidinediones. These drugs act by binding to peroxisome proliferator-activated receptors (PPARs), a group of receptor molecules inside the cell nucleus. Each drug in the class works a little differently, but they all lower blood sugar by increasing insulin sensitivity.
There have been 3 drugs of this class approved for use in diabetes:
- Avandia (rosiglitazone) approved by the FDA in 1999.
- Actos (pioglitazone) approved by the FDA in 1999.
- Rezulin (troglitazone) approved by the FDA in 1997. Rezulin became associated with liver inflammation and was withdrawn from the US market in 2000.
For now, the FDA advises:
"Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes."
For the NEJM article that spurred the FDA's safety alert (free full access):
Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes
For the FDA's safety alert:
FDA Issues Safety Alert on Avandia
For GlaxoSmithKline's press releases:
May 21, 2007 - GlaxoSmithKline strongly defends its record on Avandia
May 21, 2007 - GlaxoSmithKline responds to NEJM article on Avandia
For Avandia's website:
Avandia (rosiglitazone maleate)
Diabetes Drug Avandia Linked To Heart Risks; Vioxx Parallels Cited
"We Don't Need a Public Panic."