The US Food and Drug Administration (FDA) is lifting restrictions on the prescribing and use of the diabetes drug rosiglitazone (Avandia, Avandamet, Avandaryl, GlaxoSmithKline) on the basis of recent data that demonstrate no elevated cardiovascular risk.
"Although some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines still remains, in light of the new re-evaluation of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, our concern is substantially reduced," the FDA said in a statement.
Finally a more sober assessment. The issue of Avandia and cardiovascular disease was hyped in 2007 when this meta-analysis came out. I tried to apply some perspective but in no time the hype took on a life of its own.
One of the authors of the meta-analysis (Dr. Steve Nissen) didn't seem to mind. In fact, he threw a little fuel to the fire, saying in an interview that Avandia deaths would dwarf the carnage of 911. And his meta-analysis didn't even show a statistically significant increase in deaths attributable to Avandia.
The potential for macrovascular harm from older diabetes drugs had been known for decades but was never hyped in this manner. The screaming was so loud it was hard to have a nuanced discussion though I tried, here and in other posts.