Safe use of antiepileptic medicines
06.05.2009
The U.S. Food and Drug Administration (FDA) announced the end of a review of a group of antiepileptic medicines and recommendations regarding the safety of their use in relation to the risk of suicidal thoughts and/or behaviour.Eleven antiepileptic medicines were included in the joint, placebo-controlled, clinical study, where these medicines were used in treatment of epilepsy, psychiatric disorders and other conditions. An increased risk of suicidal thoughts and/or behaviour has been identified in all assessed antiepileptic medicines (carbamazepine, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbamazepine, pregabalin, tiagabine, topimarate, valproate, zonisamide) with different action mechanisms and used for different indications.
The analysis demonstrated that patients who were taking antiepileptic medicines had a risk which is approximately twice as high (0.43%) as in the patients receiving placebo (0.22%). The increased risk was observed as early as one week after starting the antiepileptic medicine and continued through 24 weeks. This relative risk is higher in patients with epilepsy when compared with the patients taking one of the said medicines for psychiatric or other conditions.
In view of the fact that all antiepileptics have the same risk of developing adverse reactions, there is no need to change the therapy if epilepsy is well managed.
The Agency for Medicinal Products and Medical Devices has not recorded a single case of suicidal thoughts or behaviour in patients using the antiepileptics in the Republic of Croatia.
Health professionals should closely monitor their patients who are currently taking any antiepileptic medicine, or are about to start taking them, in order to be able to observe any changes in their behaviour which could point to development or worsening symptoms of suicidal thoughts and/or behaviour or occurrence of depression.
The Agency for Medicinal Products and Medical Devices of the Republic of Croatia will approve amendments to the medicinal product information (Summary of Product Characteristics, Patient Leaflet) for the above group of medicines and continue to closely monitor the safety of this group of medicinal products.
The Croatian Agency for Medicinal Products cooperates with all competent institutions and agencies in the EU and worldwide in joint monitoring activities related to the safe use of this group of medicines, and in case of any new safety information, it will be able to react promptly.
You can use the link below in order to read the FDA announcement: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic
