The diabetes drug Avandia, which generated US$1.2 billion for GlaxoSmithKline last year, has been banned in Europe and restricted in the US.
It is yet another blow for Big Pharma. AFP reports that in the United States, the Food and Drug Administration has severely restricted the drug after data suggested “an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated”.
Concern has been mounting over the drug’s active substance rosiglitazone. Sales of Glaxo’s other diabetes drugs Avandamet and Avaglim, which contain the substance, have also been halted in Europe.
In Malaysia, concern had already been expressed about rosiglitazone in a Malaysian Adverse Drug Reactions newsletter published in September 2007 by the National Pharmaceutical Bureau of the Malaysian Health Ministry. The newsletter reported that the New England Journal of Medicine had raised concerns about a statistically significant risk of myocardial infarction (heart attack) among users. But the Health Ministry then advised patients who have underlying heart disease not to stop taking their medication until they had consulted their doctors.