European Regulator To Review Data On Diabetes Drug

The European Medicines Agency, which licences drugs in Europe, is to review all data on Avandia, a blockbuster diabetes drug from GlaxoSmithKline.

The EMEA could order extra warnings be placed on the drug or revoke its licence. American drugs regulators are doing the same.

Avandia works by making the body more responsive to insulin which controls blood sugar levels. In type two diabetes patients do not make enough insulin or are resistant to it.

However it is thought it raises the risk of heart failure by encouraging water retention which means the heart is put under extra strain as it has a greater volume of blood to pump.

Rosiglitazone is also contained in other medicines in combination with other drugs.

More than 500,000 prescriptions for rosiglitazone were dispensed in England in 2009, meaning that at least 50,000 people could be taking it.

The drug has already been through one review when warning labels on the packets were ordered to be strengthened to say that it should not be used in patients with heart problems but new studies have been published since then.

Dr Tony Hoos, European Medical Director for GlaxoSmithKline, which makes the drug, said: "GSK is fully committed to patient safety and believes that rosiglitazone is an important treatment option for appropriate Type 2 diabetes patients.

"It is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients. Diabetes is a chronic, long term condition with serious consequences, and patients should not stop taking rosiglitazone, or any other medicine for type 2 diabetes, without consulting their doctor."

Studies published last year suggested the drug, rosiglitazone or Avandia, was linked with heart failure and increased risk of death.

Canadian researchers found those on the drug, used to treat type two diabetics, were 23 per cent more likely to develop heart failure and had a 14 per cent higher chance of dying when compared with a similar drug.

Dr. Wolfgang C. Winkelmayer and colleagues at Harvard medical School showed death rates for patients on Avandia were 15 percent more likely and congestive heart failure rates were 13 percent higher than those who took ACTOS or pioglitazone hydrochloride tablets made by Takeda Pharmaceuticals North America Inc.

Dr. Winkelmayer et al. came to the conclusion after they meta-analyzed 42 studies involving 28,361 patients who had been tracked for up to five years.

The study was published in the Nov 24, 2008 isue of Archives of Internal Medicine.

Dr. Steven Nissen, a prominent heart specialist and chief of cardiovascular medicine at the Cleveland Clinic, one of the best heart clinics in the world, early analyzed data from 42 clinical trials of Avandia and found Avandia patients were 43 percent more likely to have a heart attack or be hospitalized for blocked coronary arteries than others in the studies.

At an FDA briefing, back in 2007, Dr. David Graham, a veteran drug safety reviewer of the FDA's Office of Surveillance and Epidemiology told FDA advisory panelists that the Glaxo's diabetes drug should come off the marketIn older adults, compared to pioglitazone, rosiglitazone (Avandia).

He concluded Avandia

increased risk of hospitalized heart failure

increased risk of stroke

increased risk of death

increased risk of composites for AMI (acute myocardial infarction) or death, AMI, stroke, or death, AMI stroke, heart failure or death,

increase all-cause death most likely due to increase in out-of-hospital SCD (sudden cardiac death).

But GSK insisted a comprehensive review submitted to the panel showed Avandia was safe, adding: "Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia. Together they show that this medicine does not increase the overall risk of heart attack, stroke or death."



Source: Medindia