Drug Ban as Experts Probe Sudden Deaths; ALERT FOR SCOTTISH SCHIZOPHRENICS AFTER REPORT OF CARDIAC ARREST LINK

Article excerpt

Byline: LESLEY ROBERTS

A CONTROVERSIAL drug to treat schizophrenia has been dramatically withdrawn from the market after reports of sudden death among users.

The manufacturer of Sertindole has suspended the drug following fears of heart complications. Nine British users have died since the drug appeared on the market in 1996.

A confidential memo from the Committee on Safety of Medicines circulated to British health bosses and psychiatrists instructs them to conduct an urgent review of all patients being given the drug and to block any further prescriptions.

The drug was used to treat negative moods and hallucinations but 36 European patients who took Sertindole, also known as Serdolect, have died.

The Danish manufacturer Lundbeck Ltd insists there is no evidence to implicate its drug in the deaths but is removing it from sale while the cases are examined.

Psychiatrists and support organisations for schizophrenics have expressed concern that the drug was licensed for use in the UK.

Heart problems had been developed by some patients involved in clinical trials in the United States.

As a result, Sertindole was issued on the understanding that patients were given an ECG heart test before taking the drug and received regular monitoring.

Government watchdog the UK Medicines Control Agency is believed to be concerned that there may have been cases of sudden cardiac death despite this precaution.

The agency is reassessing the safety of Sertindole and is expected to report within three months.

The temporary withdrawal of the drug means disruption in the treatment of around 90 Scottish schizophrenia patients.

It comes days after Health Secretary Frank Dobson announced plans to return mental patients to hospital if they refused to take medication, fundamentally acknowledging the failure of care in the community.

Dr David Cunningham Owens, spokesman for the Royal College of Psychiatrists, said he had known about problems with Sertindole for some time.

'I was very surprised that it was licensed in Britain, especially when we knew that there were several more of these new-style drugs in the pipeline which did not require regular ECG monitoring,'explained Dr Cunningham Owens of Edinburgh Royal Infirmary. …