Call to ban risky diabetes drugFound to increase heart attack risk
People with type 2 diabetes are still being prescribed with a drug two months after a UK panel of experts recommended it be withdrawn due to serious side effects.
Rosiglitazone, sold under the name Avandia, helps lower blood sugar levels in patients with type 2 diabetes.
Since its approval for use by the European Medicines Agency in 2000, several studies have suggested that the drug may lead to an increased risk of heart attack.
In July this year a panel of experts advised the UK Medical and Healthcare Regulatory Authority that the drug should be withdrawn as the “risks of rosiglitazone outweigh its benefits and that it no longer has a place on the UK market”.
In today's British Medical Journal, Editor in Chief Dr Fiona Godlee said the drug should not have been licensed and should now be withdrawn.
After obtaining documents under the Freedom of Information Act, Dr Deborah Cohen, investigations editor of the BMJ, concluded that the European approval process was not rigorous enough.
She also called for better access to the raw data used to license drugs to allow it to be scrutinised by the scientific community.
The report said doctors are advising that no new patients be treated with Avandia. Patients already taking the drug should contact their GP for their case to be reviewed. Those at higher risk of heart disease should be advised to stop taking it.
Professor Nick Freemantle at the University of Birmingham called for an overhaul in the standards of regulatory trials to minimise the risk of a similar situation occurring in the future.
“In order to learn from our mistakes, we must improve the quality of safety data from clinical trials on all new health care interventions, not just anti-diabetic drugs,” Dr Freemantle said.
Professor John Yudkin of University College London added: “Ten years after the release of rosiglitazone, we still cannot accurately quantify the harm to which we were exposing our patients.
“We need to be absolutely certain that our long term treatments for type 2 diabetes are not causing the very harm they are meant to prevent.
"And if the regulatory bodies do not insist on clear evidence of greater benefit than harm, they are failing in their basic purpose.”
This article was published on Mon 6 September 2010
Image © evgenyb - Fotolia.com
Use this story
Link to this page
Printer friendly version