Sertindole suspended due to safety concerns DRUG REACTIONS Lundbeck Ltd, the manufacturer of the antipsychotic agent sertindole [' Serdolect'] is voluntarily suspending availability of the agent, according to a 'Dear DoctorlPharmacist' letter from Professor M Rawlins, Chairman of the UK Committee on Safety of Medicines (CSM). This suspension follows concern regarding reports of cardiac arrhythmias and sudden cardiac death associated with sertindole. A full evaluation of the risks and benefits of treatment with this agent in collaboration with the CSM and other European regulatory authorities is pending. In the letter from Professor Rawlins, prescribers are advised that no further patients should start treatment with sertindole. Also, for patients who are receiving treatment with sertindole, the drug should be discontinued and replaced with an alternative treatment. Rawlins M, Committee on Safety of Medicines. Suspension of aVailability of Serdolect (sertindole). Media Release: [2 pages]. 2 Dec 1998 _, 1173-832419811187-1lOO211$O1.000 Adl. InternatIonal LImited 11K18. All rlght8 rH«ved 21 Inpharma e 12 Dec 1998 No. 1167

Sertindole suspended due to safety concerns

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Sertindole suspended due to safety concerns

DRUG REACTIONS

Lundbeck Ltd, the manufacturer of the antipsychotic agent sertindole [' Serdolect'] is voluntarily suspending availability of the agent, according to a 'Dear DoctorlPharmacist' letter from Professor M Rawlins, Chairman of the UK Committee on Safety of Medicines (CSM).

This suspension follows concern regarding reports of cardiac arrhythmias and sudden cardiac death associated with sertindole. A full evaluation of the risks and benefits of treatment with this agent in collaboration with the CSM and other European regulatory authorities is pending.

In the letter from Professor Rawlins, prescribers are advised that no further patients should start treatment with sertindole. Also, for patients who are receiving treatment with sertindole, the drug should be discontinued and replaced with an alternative treatment. Rawlins M, Committee on Safety of Medicines. Suspension of aVailability of Serdolect (sertindole). Media Release: [2 pages]. 2 Dec 1998 _,

1173-832419811187-1lOO211$O1.000 Adl. InternatIonal LImited 11K18. All rlght8 rH«ved

Inpharmae 12 Dec 1998 No. 1167