Adverse event monitoring in lamotrigine patients: a pharmacoepidemiologic study in the United Kingdom.

PURPOSE

This postmarketing surveillance study of lamotrigine (LTG) was performed to provide complementary data to large-scale Prescription-Event Monitoring study with a retrospective case records survey in five tertiary referral epilepsy centres in the United Kingdom.

METHODS

Adverse events were recorded and compared with those of two other new antiepileptic drugs (AEDs), gabapentin (GBP) and vigabatrin (VGB). All deaths were followed up and standardised mortality ratios (SMRs) were calculated. Serious adverse events were assessed individually.

RESULTS

A total of 2,701 patients was identified as being exposed to LTG and/or the comparators. It was necessary to exclude 1,326 patients because LTG and/or comparators had been commenced outside the study centres. The adverse events with LTG reported by this study were similar to those reported in the literature. Skin rash was the major adverse event. Life-threatening hepatic failure, acute exacerbation of ulcerative colitis, disseminated intravascular coagulation, and renal failure were reported. No death could be directly attributed to the use of LTG. The SMR was slightly higher than that reported in the literature; this probably reflects severity of epilepsy in the study population.

CONCLUSIONS

The safety profile of LTG was similar to that in the large-scale Prescription-Event Monitoring study and generally acceptable. Life-threatening adverse reactions were rare.