Avandia too dangerous for market?
In a somewhat surprising turn of events, FDA reviewers are calling for the diabetes drug Avandia to be removed from the market.

Could one of Big Pharma’s biggest-selling drugs actually be a thing of the past? Could the FDA actually be taking steps to protect the public?

Shockingly enough, it looks like it.

Two drug-safety reviewers have recommended that GlaxoSmithKline blockbuster Avandia be removed from the market. They say the drug is more dangerous to the heart than a rival medicine. Sound familiar? Just last fall I wrote an e-Tip about the numerous dangers associated with Avandia.

Avandia has come under the scrutiny of FDA reviewers before — back in 2007, studies started linking Avandia to heart attacks. But this time is different — this time, they’re saying “get rid of it.”

And the situation is particularly disturbing. Because it’s not just about Avandia’s link to heart failure and heart attacks. Two senators recently released a report based on 250,000 documents, including hundreds provided by anonymous whistle blowers. The gist? It suggests that Glaxo KNEW about these problems for years before the 2007 study.

So, is the second time the charm?

We’ll see. After all, we’re talking about Glaxo’s second-biggest-selling drug here. You can bet they’re not going to just step aside and let the FDA pull Avandia that easily.

And even if they did, change isn’t going to come quickly. This whole story has already been moving at a turtle’s pace. The same FDA reviewers said Avandia should come off the market in 2007 because of serious heart dangers. But an advisory panel, perhaps bowing to business pressure, voted 22-to-1 to keep it on the market.

Good going, guys. It’s not like the heart risks were going to go away if you simply pretended they weren’t there. And now we’ve had three more years of unnecessary risk, only to arrive back where we started.

Hopefully, this time it will take. I have to say, I’m not incredibly optimistic about this one, considering Glaxo is pressing for the advisory committee to review a study that shows no link between Avandia and heart risks. A study Glaxo sponsored. One that has absolutely no place in this discussion.

In the meantime, everyone with diabetes should know about this development. If you know someone who might be taking Avandia, I urge you to forward this letter to him or her.

Sources:
“Reviewers urge Glaxo’s Avandia come off market,” Reuters (www.reuters.com)
“Remove Diabetes Drug Avandia From Market: FDA Documents,” Yahoo! News (news.yahoo.com)