Diabetes drug Avandia should no longer be issued to new patients because of concerns it increases the chances of strokes and heart attacks, according to a regulator.
The widely-used drug’s benefits no longer outweigh its risks, according to the committee on medicinal products for human use at the European Medicines Agency (EMA).
No further prescriptions should be issued and marketing of the product should be halted, the EMA committee ruled.
Medicines and Healthcare products Regulatory Agency (MHRA) chief executive Professor Kent Woods said: “Patient safety is the top priority for the MHRA and we have been constantly monitoring the situation regarding rosiglitazone.”
Treatment plans of those currently receiving the drug should be looked at and altered where appropriate.
The US Food and Drug Administration, in a separate ruling, said access to the pill should be restricted. It ruled new patients would only get a prescription for Avandia if they could not control their diabetes with other medications.
The drug was once the top-selling diabetes pill in the world but use plummeted after a 2007 analysis linked it to heart attack risks.
GlaxoSmithKline (GSK), which produces the drug, said the company continues to believe it is an important treatment.
Copyright Press Association 2010
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“At the recent American Diabetes Association Science Conference in Orlando, Florida, Albert Einstein Medical College presented the results of two human trials using Biotivia Transmax in place of Avandia. Transmax, a purified form of the natural substance resveratrol, which is found in grape skins, performed extraordinarily well in lowering blood glucose, improving glucose tolerance, increasing insulin sensitivity and enhancing mitochondrial function, all with no adverse effects or toxicity. It is time this safe and reasonably cheap natural compound be taken seriously by all type 2 diabetes sufferers?” – Benjamin Meeks, London, UK