Federal regulators are trying to determine whether the diabetes drug Avandia should be pulled from the market.
The Food and Drug Administration will hear two days of evidence around whether the popular medication causes heart attacks. There have been over 13,000 lawsuits involving Avandia. GlaxoSmithKline, which makes Avandia, argues its drug is safe and "has a positive benefit/risk profile" when it's used appropriately.
The New York Times reports that Glaxo has known about Avandia's heart risks for over a decade but kept the information secret.
Bloomberg News is reporting now that Glaxo has agreed to pay $460 million to settle some of the 13,000 lawsuits over the drug.
MPR's medical analyst Jon Hallberg spoke with Tom Crann on All Things Considered about Avandia and its risks.
Tom Crann: What is Avandia? What does it do?
Jon Hallberg: It's a medication that sensitizes tissue to insulin. Insulin allows glucose or blood sugar to get into the tissue. So it's one of the main drugs we have at our disposal to try to control blood sugar levels in Type II diabetes.
Crann: What has been the problem with this drug?
Hallberg: From early on, it's been pretty clear that this drug and a couple other ones like it cause peripheral edema, or swelling, typically in people's feet and ankles. That appears to be a sign that they're getting fluid overloaded, and that fluid overload in our system can lead to congestive heart failure.
Crann: How common a treatment is Avandia for diabetes?
Hallberg: It's been around since 1999 and it's been a huge seller. It's certainly a medication many of us have prescribed many times to millions of patients. After the problems started coming up in about 2007, a lot of patients were switched to other drugs. But there are still hundreds of thousands of patients on Avandia.
Crann: So if the FDA pulls it, are you losing an important tool to deal with diabetes?
Hallberg: No. There's always other options available. In this case it's Actos. It works as well and actually seems to have fewer side effects. And this is just one of three main categories of drugs to treat people with Type II diabetes. There are other options to go with, and even in this category there are other options.
Crann: What do you think when a drug manufacturer withholds research for 11 years about risks, as The New York Times as reported?
Hallberg: If that's in fact the case, it's horrible. It's unconscionable. We physicians and providers who write prescriptions are in a position where people trust us.
One of the complications of this drug is heart disease, and this drug is supposed to prevent that, and in fact it seems to be causing it at a greater than expected rate. So it's just why in the world would this drug be on the market and why would we keep prescribing it if we know this information?
Crann: What information do you use to make a decision about whether to prescribe a drug for a patient?
Hallberg: I try to make the decision on sound information and good studies. I'm very partial to medications that have been on the market for years. Sadly, this medication has been on the market since 1999, so one would think that it's safe.
But by and large, cheaper generic medications that have stood the test of time that have withstood randomized controlled trials, make the cut.
I am personally not very interested in brand new drugs for this reason --- because I just feel like they're unproven to some extent and I don't feel comfortable with their side effect profiles until they've been on the market for some time.
(Interview transcribed and edited by MPR News reporter Elizabeth Dunbar.)