The British Medical Journal said that GlaxoSmithKlinePLC’s diabetes drug Avandia’s license should be revoked and should be withdrawn from sale. As of now the the European Medicines Agency is reviewing Avandia and will advise whether or not it should continue on the market later this month. The U.S. Food and Drug Administration is soon to make its decision on Avandia subsequent to a U.S. advisory panel vote in July to keep it on the market but with additional warnings.
Avandia was once Glaxo’s second-biggest drug, raking in about $3 billion a year annually. But its sales have dipped since a U.S. study connected it to heart attacks in 2007.
GlaxoSmithKline Monday rejected the BMJ’s claims. It said it has carried out an extensive research program involving more than 50,000 patients to analyze the safety and benefits of rosiglitazone.
“We have rigorously shared our data relating to the cardiovascular safety of Avandia in a timely and transparent manner and have made extensive efforts to publish our clinical trial findings in peer review journals, at scientific meetings and via our own clinical trials website,” said Glaxo.
