Recent evidence indicates that Avandia, a drug taken by millions to control diabetes, causes heart attacks and heart failure. Congress has held hearings, the American Diabetes Association has warned patients taking Avandia to talk to their physicians, and sales of Avandia have fallen sharply. GlaxoSmithKline has taken on full page ads defending its drug and claiming it is safe. If you are a diabetic taking Avandia, what should you do?
First, the facts. Avandia was approved in 1999 after clinical trials with 5500 patients. It was found to be effective in diabetics for controlling blood sugar. It is a member of the same drug class as Rezulin, which was withdrawn from the market in 2000 because it caused liver failure. Avandia was already known to increase the risk of heart failure, and evidence just published in the New England Journal of Medicine suggests that it increases the chances of heart attacks and deaths from heart disease about 40%. Since diabetics already have twice the risk of heart disease and are a vulnerable population, this is a serious potential concern.
These are only preliminary findings. When all the evidence is in, it might be possible that there is no increased risk. How could the possibility that Avandia causes heart disease have been missed when the drug was approved? Consider that millions now take Avandia, and that an infrequent side effect may not show up in the relatively small number of patients involved in FDA trials. This has been the problem with other drugs that have been recalled after initial approval (think of Baycol, Redux, Bextra and others), and will continue to be a problem that can only be addressed with better surveillance after a drug is released.
Diabetics taking Avandia should talk to their physicians. They are at more risk from not taking any medication than from taking Avandia, so the worst thing a diabetic could do is to stop taking their medication. Are there other alternatives? Yes, and very good ones. In addition to other oral drugs, Actos (pioglitazone is the generic name) is a member of the same drug class, and there is some evidence that it may actually have a protective effect against heart disease, although this has not been proven.
Should a diabetic, knowing what we know today, take Avandia? I think the answer is, “No.”
#1 by Jane Hitchings on July 3rd, 2008
Clearly evidence based medicine says it is safe, even safer than others considering it is the most widley studied oad out there. Lets see, do I want to take a drug where I know in long term trials has no increased risk compared to other oads & improves my sugars better than the conventional oads, or do I want to take something with unkown risks? Hmm, no brainer!