UK Health Radio – Medical News Update on the Hour Controversy Over Stroke Treatment.

UK Health Radio – Medical News Update on the Hour

Controversy Over Stroke Treatment.

The BBC has reported that the UK medicines watchdog is to review the safety of a clot-busting drug that is frequently used to treat strokes.

The Medicines and Healthcare products Regulatory Agency believes the benefits of alteplase outweigh the risks but is now is revisiting the evidence in the light of the fact that experts say previous assessments may have been flawed. A stroke is a medical emergency - and there is one every five minutes in the UK and most strokes are caused by a clot blocking the flow of blood to the brain.

The Academy of Medical Royal Colleges welcomed the investigation, saying the review has "huge implications" for patient safety. Many patients are given alteplase to break down and disperse the clot - treatment known as thrombolysis.

However there is an increased risk of dangerous bleeding in the brain, although regulators have concluded this is outweighed by the benefits of improved recovery. Some experts, however, disagree.

Dr Roger Shinton, a stroke specialist, set out his concerns in a letter published in the Lancet.

He told the BBC: "My concerns about using alteplase for stroke have always been that the risks of this drug are quite considerable, particularly with bleeding into the brain. The question is, do the benefits justify that risk? And I am not myself convinced that they do. I have met with some of the regulatory bodies, and I think they understand there may have been a problem with the balance in the way that this drug was reviewed at the time, and that is why there is some movement to re-look at the whole matter.”

Dr Shinton added that many stroke specialists shared his concerns.

Responding in the Lancet, the Medicines and Healthcare products Regulatory Agency (MHRA) said it had recently examined the issue and concluded that the balance of benefits and risks was still favourable. But it also confirmed it was setting up an expert working group "to ensure all relevant sources of evidence have been taken into consideration". It said it expected the inquiry would report its findings early next year.

Jon Barrick, chief executive of the Stroke Association, said treatment by thrombolysis using alteplase was part of the great progress in stroke treatment.

"No treatment is without risks. The NICE [National Institute for Health and Care Excellence] recommendation on the use of alteplase is based on current evidence that shows overall the benefits outweigh the risks. Eligible patients treated with thrombolysis are more likely to have a good outcome and more people are surviving stroke and leading independent lives." The manufacturers, Boehringer Ingelheim, say they stand by the safety of the drug.

Amanda Thomas

UK Health Radio Medical News Update

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