The restrictions on prescribing and taking GlaxoSmithKline’s controversial diabetes drug Avandia may be eased or removed after advisers to the US Food and Drug Administration found that the risk of cardiovascular events may be overstated.
13 out of 26 physicians in the panel voted to modify the restrictions, which currently only allow the drug to be prescribed for patients with type 2 diabetes who cannot control their blood sugar levels with other drugs, while seven advisers recommended removing them completely.
Five remaining members voted to continue with the restrictions and one voted to take the drug off the market.
In September 2010, the FDA limited access to Avandia (rosiglitazone), which was once a blockbuster drug, after researchers raised questions about possible links to heart attacks. Meanwhile, EU regulators banned the pill altogether.
But the FDA decided to review the restrictions after an independent review of an original clinical study confirmed that the drug did not raise the risk of mortality and major adverse cardiac events.
GSK chief medical officer Dr James Shannon said; "We appreciate the committee’s thorough examination of the results and will continue to work with the FDA as it considers the recommendation of the committee."
"We continue to believe that Avandia is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labelling," added Shannon.
The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee is not binding, and will now be considered by the FDA.
Image: Despite accusations of a link to heart attacks, GSK maintains that Avandia is safe and effective. Image: Courtesy of GSK.
