British FDA to pull Avandia off the markey

[Rachel_R]

On Monday, Britain's Medicines and Healthcare products Regulatory Agency (MHRA), said Avandia should be pulled from the UK market because of concerns that the drug could increase the risk of heart attacks.

They said an independent panel of experts had advised that the risks of the product outweighed its benefits, and that the drug should no longer be sold in Britain.

The body said it had sent a letter to doctors in July advising them to consider alternative treatments.
Avandia, made by pharmaceutical company Glaxo Smith Kline (GSK), was approved by the EMA in 2000 to help lower blood sugar levels in patients with Type 2 diabetes.

GSK has maintained that its extensive research involving over 50,000 patients has shown that Avandia does not increase the overall risk of heart attack, stroke or death compared to other diabetes drugs.

"We continue to believe that Avandia is safe and effective when it is prescribed appropriately," the company said in a statement.

But the British Medical Journal was critical of both GSK's research methods and the European approval process, outlining what were described as multiple problems associated with Avandia's safety in a report published on Monday.

In the US, the Food and Drug Administration (FDA) has placed Avandia under scrutiny since 2007, when a study suggested that patients taking the drug were 43 per cent more likely to experience a heart attack than those taking other diabetes drugs or no diabetes medication at all.

If you currently take Avandia, would you:

[Rachel_R]

Sept 30th news, Avandia is now banned in Europe and the FDA has put restrictions on Avandia that may reduce sales to zero. Consumer Reports today slammed the FDA's decision to allow Avandia to remain on the market.

[caregiver222]

I have reviewed the Avandia studies, as well as the voluminous information on the FDA site. Avandia was first approved in 1999.

The United States FDA has continued to approve Avandia, subject to a change in the package insert to reflect caution when prescribed to those with pre-existing heart conditions.

In addition the U.S. F.D.A. set up two phone lines to be used by patients taking Avandia to provide feedback in the event of an adverse effect:

1-800-332-1088

FAX: 1-800-FDA-0178

The studies upon which the British F.D.A. based their decision seem to indicate a difference between 2% and 2.6% in the incidence of cardiac fatalities. The population upon which the study was conducted, included people with pre-existing cardiac conditions. The U.S. F.D.A. concluded that Avandia provides superior glucose control and a higher quality of life, and the benefits outweigh the risks for a patient without an existing cardiac condition.

Before making a decision to discontinue Avandia, I would review the information provided on the F.D.A. website, which includes a detailed analysis of their decision to keep the drug on the United States market.