The Medicines and Healthcare products Regulatory Agency believes the benefits of alterplase outweigh the risks. But it is revisiting the evidence. Some experts say previous assessments may have been flawed.
The Academy of Medical Royal Colleges welcomed the investigation, saying the review has “huge implications” for patient safety.
A stroke is a medical emergency – and there is one every five minutes in the UK. Most strokes are caused by a clot blocking the flow of blood to the brain. Many patients are given alteplase to break down and disperse the clot – treatment known as thrombolysis.
Concerns over ‘balance’
There is an increased risk of dangerous bleeding in the brain, but regulators have concluded this is outweighed by the benefits of improved recovery. However, some experts disagree.
Dr Roger Shinton, a stroke specialist, set out his concerns in a letter published in the Lancet.
He told the BBC: “My concerns 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.
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”.
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