Avandia - Our Take on the Controversial Diabetes Drug

The diabetes drug Avandia has been the subject of intense focus and debate - and confusion - in recent months. A study published in a leading medical journal in May 2007 indicated the drug may be associated with a higher risk of heart attack compared to a placebo or other diabetes medicines. Since then, several analyses of existing data on tens of thousands of patients have confirmed this observation.

But none of the studies offered hard proof of Avandia's link to a higher heart attack risk. And Avandia's maker, GlaxoSmithKline, has pointed to several older studies that did not seem to find such a problem. Based largely on this uncertainty and lingering questions about the methodology of the studies finding the link, an expert advisory panel to the Food and Drug Administration voted in July to keep the drug on the market.

After what press accounts characterized as a fierce internal debate - and a very close 8 to 7 vote in favor of Avandia by the agency's Drug Safety Oversight Board - the FDA in November formally concurred with the outside panel's advice to keep Avandia on the market. But the agency announced at the same time that GlaxoSmithKline had agreed to warn doctors and patients about the possible heart attack risk (on the drug's labels and in patient information), and to undertake a new long-term study on its safety.

The agency acted deliberatively and responsibly but should have gone farther. The new patient information material advises people with type 2 diabetes who also have diagnosed heart disease, or risk factors for heart disease, to talk to their doctors about the benefits and risks before taking Avandia.

We believe that people with type 2 diabetes who have been diagnosed with heart disease or have any other risk factors should not take Avandia under any circumstances until future studies, including the one GlaxoSmithKline will now initiate, fully exonerate the drug.

The rationale for this advice is two fold: (a) people with type 2 diabetes are already at considerably higher risk for heart disease and heart attack and taking a drug that possibly elevates that risk simply makes no sense; and (b) there are several alternative diabetes drugs which have quite good, and better known, safety track records. Several of those are low-cost generic drugs. Another is a drug named Actos which is in the same class as Avandia. To date, no studies have suggested Actos elevates heart attack risk and two studies have indicated it is associated with a significantly lower risk.

Since the majority of people with type 2 diabetes have other risk factors for heart disease (such as high blood pressure, high cholesterol, kidney disease, overweight or obesity) in addition to diabetes, we urge people with the condition who are currently taking Avandia to talk with their doctor about switching to another oral diabetes drug.

Our advice is consistent with the recommendations of health authorities in Canada, who urged doctors to use Avandia only in rare circumstances.

For more details, read our detailed report on all the oral diabetes medicines - from Consumer Reports Best Buy Drugs, a Consumers Union public education project.

Comments

[Raymond]

I would remind those dedicated to research that sometimes it's more important to manage the primary disease (diabetes)aggreseven try to separate the so the individual patient can live long enough to enjoy the debate on his risks of heart disease. I cannot imagine a more difficult disease than diabetes to attempt separating the disease effects from medication's cardiac side effects.

In this case there should be enough data to compare longevity and quality of life with Avandia users versus non-users. RWM

[Pharmacy]

Diabetes is such a disease which could be dangerous to anyone, who is suffering from it, and the information given above in this post should be very useful help those people to fight this disease. Diabetes can creat a great problem for the BP patients…....