Avandia Risks

Type II diabetes (sometimes called adult onset diabetes) is characterized by a gradual resistance to the effects of insulin in the body. In short, the amount of insulin secreted by the pancreas doesn’t control blood sugar levels. In the earlier stages, patients may take oral medications that change the body’s response to insulin. In the later stages, patients usually have to have insulin injections.

Avandia (generic, rosiglitazone) acts on cells to sensitize them to insulin so that patients who have become resistant to the effects of their own insulin can return to a more normal state. The drug is sold in three different products, all manufactured by Glaxo-Smith-Kline. Avandia is a single ingredient form; Avandamet is a combination with metformin; and Avandaryl is a combination with glimepiride. The combinations are with drugs that increase insulin secretion with the strategy of both increasing production of insulin and increasing the sensitivity to the hormone.

Problems emerge

A study published in May of 2007 showed an increased risk of heart attack in patients taking Avandia – a serious blow to Glaxo-Smith-Kline, who in 2006 had an estimated 2.5 billion in sales for the three products.

The FDA reacted quickly and recommended the drug be restricted to patients without a history of heart failure and that patients should be followed up to see if any cardiac problems developed while on the drug.

Later in 2007, another warning, about increased risks of bone fractures in women was added to the drug packaging information. This is an important warning, because overweight women are at higher risk for bone fracture from stress or falls even without the side effects of Avandia and this population is also more likely to develop type II diabetes. (FDA updates to warnings can be found here.)

The story didn’t end there. By February of 2010, some FDA officials were recommending that Avandia should be pulled from the market entirely (ABC news report).However, the drug is still being sold.

Controversy remains

Why is the drug still being sold? Because different studies have come to different conclusions. While the risks of heart attacks is clearly greater, they may be no greater than other drugs used in type II diabetes and no worse than someone who has untreated diabetes. It is the very fog of the unknown that allows the medication to be sold.

Instead of having to prove a substance entirely safe, drug manufacturers are allowed to warn doctors about possible side effects and then the physician is entitled to use their good medical judgment and assume liability. There is one important consideration though: when a drug company withholds information from the medical community or the FDA. In this case, the manufacturer is not only liable, but can be found criminally negligent.

If you or someone you know has experienced adverse effects while taking Avandia, you can report them to Glaxo-Smith-Kline at 1-888-825-5249 or the FDA at 1-800-FDA-1088. The Consumer Complaint Coordinator for prescription drugs in Montana -- 800-353-3965.

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