E-DRUG: Antipsychotic drug suspended in the U.K.
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MESSAGE FROM PROFESSOR M RAWLINS, CHAIRMAN, COMMITTEE ON SAFETY OF
MEDICINES
2 December 1998
Dear Doctor/Pharmacist
SUSPENSION OF AVAILABILITY OF SERDOLECT (SERTINDOLE)
This is to inform you that Lundbeck Ltd., the manufacturers of Serdolect
(sertindole), are voluntarily suspending its availability from 2
December 1998. This suspension is due to concerns about reports of
cardiac arrhythmias and sudden cardiac death associated with its use. In
light of this information, the availability of Serdolect will be
suspended in the best interests of patient safety pending a full
evaluation of its risks and benefits in collaboration with the UK
Medicines Control Agency (MCA) and other European regulatory
authorities.
Prescribers are advised as follows:
�No further patients should be initiated on Serdolect.
�Existing patients should be recalled for review by their psychiatrist.
�No patient should have Serdolect stopped until a suitable alternative
treatment has been prescribed.
�Serdolect should be withdrawn and replaced with an alternative
treatment.
�Serdolect may be stopped immediately and the patient transferred
straight away to an alternative treatment, such as another atypical
antipsychotic.
�Alternatively, if the psychiatrist judges it appropriate for a
particular patient, Serdolect may be tapered off by a stepwise reduction
over a period of up to two weeks whilst the replacement antipsychotic
therapy is initiated.
Doctors or hospital pharmacists who suspect that one of their patients
has suffered an adverse drug reaction while on Serdolect, should report
this to the MCA/Committee on Safety of Medicines through the Yellow Card
Scheme. We shall continue to review all available data on Serdolect, and
will contact you again when we are in a position to make clear
recommendations regarding its use following the above review process.
Should you require any further information, please call:
� Lundbeck Ltd on 01908 649966,
� the MCA on 0171 2730000
Yours faithfully
Professor M Rawlins
Chairman, Committee on Safety of Medicines
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