DRUG BAN AS EXPERTS PROBE SUDDEN DEATHS ALERT FOR SCOTTISH
SCHIZOPHRENICS AFTER REPORT OF CARDIAC ARREST LINK

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withdrawn from the market after reports of sudden death among users.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.

Schizophrenic patients are notoriously difficult to monitor and medics
prefer to prescribe medication that is easy to use.

Dr Cunningham Owens added: 'The drug wasn't widely used for that
reason.'

Sertindole is one of a series of new-type anti-psychotic drugs
developed in the early Nineties.

Although more expensive than conventional medication for the treatment
of schizophrenia, they are believed to deal effectively with symptoms
without causing stigma-tising side effects such as grimacing.

Scottish pharmacies issued 1,064 prescriptions of the drug last
year.

There have been no reported deaths of Sertindole patients in
Scotland.

A Scottish Office spokesman urged patients to seek medical
advice.

'Patients being treated with Serdolect or Sertin-dole should continue
to take their tablets and see their doctor or nurse as soon as
possible,' she said.

The Committee on Safety of Medicines originally did not attempt to
prevent the sale of Sertindole in Britain, despite being aware of the
possible problems with its use.

However chairman Professor Michael Rawlins admits members have had to
reassess that position.

British managing director of Lundbeck, Jarne Elle-holm, said the
company had moved to protect patients.

He said: 'The deaths that have been reported are in no way necessarily
caused by the drug. Schizophrenia patients have more than double the
mortality rate of other people.' Shona Barcus, chief executive of the
Scottish Association for Mental Health, said she welcomed the decision
to remove Sertindole from the market.

Mary Weir, of the National Schizophrenia Fellowship, said she was
concerned that patients did not panic and stop taking the drug before
being given a replacement.

'Terminating their treatment could prove even more risky,' she
said.