Avandia restricted to limited Type 2 diabetes patients

The Food and Drug Administration announced Thursday that access to the diabetes drug Avandia will be restricted to patients with Type 2 diabetes whose condition cannot be controlled with other medications.

Also Thursday, the European Medicines Agency recommended that Avandia be taken off the market. The EMA is Europe’s counterpart to the U.S. Food and Drug Administration (FDA), and is responsible for the approval of all drugs and medical devices sold in Europe. To go into effect, the decision must be ratified by the European Commission.

“As a result, physicians in Europe are being advised that affected patients need to be transitioned to alternative treatment options,” the drug’s maker GlaxoSmithKline said in a statement.

The drug has been linked to raised risks of cardiovascular events, such as heart attack and stroke, in patients treated with it.

A recent article in the British Medical Journal argued the drug never should have reached the market in the United Kingdom, reports CNNMoney.

In July, an FDA panel gave a split decision on Avandia – most members agreed to leave it on the market, but recommended changes in prescribing it.

Type 2 diabetes is a condition that affects the way the human body metabolizes sugar. Symptoms include weight loss, fatigue, blurred vision, frequent urination, and increased hunger and thirst. There is no cure, but patients can manage their conditions with proper diet and exercise; medications or insulin therapy may also be needed, says the Mayo Clinic.

About 8 percent of the U.S. population – or nearly 24 million people – is living with diabetes, and 90 percent of those cases are Type 2, according to the National Diabetes Information Clearinghouse.

Avandia was approved in 1999 after trials by GlaxoSmithKline (then known as SmithKline Beecham) showed that it could lower blood sugar, by improving the body’s own ability to process glucose.

The drug went on the market in the U.S. in 1999 and became quite popular, with sales rising above $3 billion in 2006. But after a study in the New England Journal of Medicine suggesting a link to heart attacks, sales fell to about $1.2 billion in 2009.

Source: CNN