The children's dosage regimen for the anticonvulsant lamotrigine has been revised following a number of adverse drug reaction reports.
Since August, 1997, 11 cases of serious skin reactions in children have been received by the Committee on Safety of Medicines, with the majority requiring hospitalisation. Over 40 per cent of the patients were on a higher than recommended dose.
The new regimen, which is detailed in a new summary of product characteristics, and in the current issue of Current Problems in Pharmacovigilance (2000;26:3), reflects new pharmacokinetic data and should reduce the risk of serious skin reactions, says the CSM. Prescribers have been strongly advised to follow the new dosage regimen.
Rare blood dyscrasias have also been reported following lamotrigine use (ibid, p4). Health care professionals are advised to be alert for warning signs suggestive of bone-marrow failure, such as anaemia, bruising or infection associated with lamotrigine use.
The CSM says that it is not recommending routine blood monitoring in view of the small number of cases that have been reported.