Ban on Glaxo’s Avandia sought

Washington, October 31: The consumer group Public Citizen has sought a ban on GlaxoSmithKline PLC’s controversial diabetes drug, Avandia. Food and Drug Administration (FDA) has been urged to materialize the ban in the wake of safety concerns arising from the use of the drug.

The move has come a week after the American Diabetes Association and the European Association for the Study of Diabetes released guidelines that recommend doctors to refrain from using the drug.

The FDA forewarned doctors about the potential increase in the risk of heart attacks due to Avandia. The FDA further added that the drug would continue to be available in the market until its safety could be properly accessed. According to FDA officials, the agency is divided on the issue of pulling Avandia off the market.

Public Citizen, in its petition filed with the FDA on Thursday, said that apart from the heart attack threat, 14 cases of Avandia-induced liver failure (which included 12 deaths) have also been observed. The FDA declined to comment immediately on the petition that has been filed regarding this case.

On the other hand, GlaxoSmithKline, the company in question, feels that the drug is safe and effective as long as it is appropriately used.

Safety aspect of Avandia has been under the scanner since last year, when studies suggested the association of the drug with an increase in the instances of heart attacks. A sharp decline in the sales of Avandia has been witnessed since the safety concerns surfaced last year. But the latest statistics show that 10,000 prescriptions are being filed for Avandia daily, as per Public Citizen.

About 20 million Americans suffer from type-2 diabetes. The condition leads to high levels of blood glucose which is a consequence of the body’s inability to make use of insulindefine. Insulin, a hormone secreted by the pancreasdefine, is required in the body to transfer sugar from the blood into the cells.

Avandia is designed in such a manner so as to help lower blood sugar. It was first approved by the FDA way back in 1999 for curing type-2 diabetes.