Fears have been raised over the safety of an anti-clotting drug used to treat stroke sufferers in Bahrain.

Researchers at UK-based medical journal The BMJ believe that the administration of alteplase three to four hours after a person has suffered a stroke could cause a secondary haemorrhage, said a report in the Gulf Daily News (GDN), our sister publication.

Most strokes are caused by a clot blocking the flow of blood to the brain.

Patients are given alteplase to break down and disperse the clot - a treatment known as thrombolysis.

There is a high risk of bleeding in the brain, but experts concluded that it was outweighed by the benefits of improved recovery.

However, the five-member team of researchers disagree and have called on health officials to urgently review policies guiding the usage of the drug.

The team is headed by Ebsco Health vice-president and DynaMed founder Dr Brian Alper and includes Eric Manheimer, a member of the Bahrain branch of The Cochrane Collaboration, an international non-profit organisation dedicated to providing up-to-date information about the effects of health care.

"Most major stroke guidelines support use of alteplase up to four-and-a-half hours after stroke onset, but we believe that this guidance is based on uncertain evidence," explained Dr Alper.

"If the policy, either by guidelines regarding policy of its usage or by licensing of the drug, says its usage up to four-and-a-half hours, it would be important to immediately reconsider the policy.

"If the policy limits the usage of the drug to three hours, then this would be a good reminder to caution on this policy."

Concerns

His concerns were shared by Cochrane Collaboration Bahrain branch director Professor Zbigniew Fedorowicz.

"The inconsistency in the results in the new piece of information indicates that harms outweigh the benefits of the drug beyond the three-hour period," he told the GDN.

"It is not the drug, but the time period. The drug appears to work effectively and safely up to three hours, beyond which it leads to secondary haemorrhage."

Metalyse is another drug used to treat strokes and heart attacks and is used as an alternative to alteplase.

It is administered in Bahrain, but the National Health Regulatory Authority (NHRA) is yet to review its usage policy.

"Any action on reviewing the policy or the usage of the drug will be taken only if we receive notification from bodies like the Food and Drug Administration, GCC Supreme Council for Health or other international bodies that Bahrain has affiliation with," said NHRA chief executive Dr Baha Eldin Fateha.

According to Dr Alper, metalyse works similar to alteplase.

"There is no direct evidence on metalyse, however the drug works similar to alteplase," he told the GDN.

"The limited direct evidence comparing metalyse and alteplase is consistent, with metalyse being a little more safe and effective.

"However, the study which revealed this was done on a small population and doesn't give us the confidence that it is safer.

"It would work the same way like alteplase and would have the same set of indications in practice."

He said British health regulator, Medicines and Healthcare Regulatory Agency (MHRA), plans to analyse all relevant sources of evidence and reassess the benefits of alteplase.

According to a report in the Daily Mail, the MHRA recently reaffirmed that the benefits outweighed the risk but also said it was setting up an expert working group "to ensure all relevant sources of evidence have been taken into consideration".

It is expected to report back next year.

German manufacturer Boehringer Ingelheim had said that it stood by the safety of alteplase. - TradeArabia News Service