Could Avandia Be Pulled from European Market?

London, EnglandAccording to the Associated Press on 9/07/10, British officials have recommended that doctors consider alternative treatments to Avandia. The move was made on the advice of an independent panel of experts who said that the risks of the type 2 diabetes drug outweigh its benefits.

The Medicines and Healthcare products Regulatory Agency (MHRA) said an independent panel of experts advised that the drug should be removed from the market. The MHRA further said it alerted doctors that they should consider alternative treatments to Avandia where appropriate.

Meanwhile, the British Medical Journal published an article calling for Avandia's immediate withdrawal from the market and saying the drug should never have been approved in the first place.

Deborah Cohen, writing for the British Medical Journal on 9/06/10, noted that Avandia's approval involved "a combination of problematic data, uncertain clinical need, politics, and poor drug company behaviour." Cohen notes that it is not clear why Avandia was eventually approved for the European market in 2000 when in 1999 the drug was rejected and no new evidence was made available between those decisions.

In fact, according to Cohen, "According to documents obtained under the Freedom of Information Act, advisers to the EMA [European Medicines Agency] noted the lack of good evidence during its [Avandia's] approval process."

GlaxoSmithKline, maker of Avandia, says the drug is no riskier than other diabetes medications.

However, the British Medical Journal criticized GlaxoSmithKline's research methods. GlaxoSmithKline (then operating as SmithKline Beecham) reportedly submitted to the EMA inadequate long-term data, evidence of safety problems and poorly documented data. Avandia was still approved for the market.

Regulators in Europe meet this week to discuss Avandia and what future it has on the market.

Earlier this year, members of a US Food and Drug Administration (FDA) advisory panel met to discuss Avandia's future in the US. Panel members voted to keep Avandia on the market, although with stricter regulations. The FDA will meet later this year to discuss the advisory panel's recommendations and decide whether or not to allow Avandia to stay on the market.