The US Food and Drug Administration (FDA) issued new information, yesterday, 31st January, to alert doctors and other health professionals about the increased risk of patients having suicidal thoughts and behaviours as a result of taking antiepileptic drugs for epilepsy, bipolar disorder, migraines, and other conditions.
The agency has just completed a review of placebo controlled studies on 11 antiepileptic drugs and found that patients who took them had two times the risk of suicidal thoughts and behaviours (suicidality) of patients who took placebo only (0.43 versus 0.22 per cent). In epidemiological terms, this is an extra 2.1 per 1,000 patients.
In March 2005, the FDA asked manufacturers of marketed antiepileptic drugs for which there were adequately designed controlled clinical trials, for the data following a preliminary analysis of several drugs that suggested an increased risk of suicidality. The agency received and analysed data from 199 such trials covering 11 drugs.
The analysis covered 27,863 patients on the drugs, and 16,029 on placebo. Among the patients taking the drugs there were 4 suicides and 105 reports of suicidal thoughts and behaviours. Among the placebo patients, there were no suicides and 35 reports of suicidal thoughts and behaviours.
The risk of suicidality was observed to increase after one week of starting on the drugs, and stayed higher for at least 24 weeks.
There was no clear pattern of risk across age groups, and the risk was the same for all 11 drugs and all demographic subgroups, said the agency.
Director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, Dr Russell Katz said:
“We want health care professionals to have the most up to date drug safety information.”
” This is an example of FDA working with drug manufacturers throughout products’ lifecycles to keep health care professionals informed of new safety data,” he added.
The agency advises patients who are presently on antiepileptic medication not to change or stop their dose until they have discussed the impact of this information with their doctor.
Doctors and other health care providers should contact their patients, their patients’ caregivers and families and let them know about the increased risk of suicidal thoughts and behaviours so they can look out for any changes in behaviour.
The full list of drugs covered by the FDA analysis is shown below. Note that some of them are also available in generic form.
The FDA said that although they only analysed these drugs, they fully expected the increased risk of suicidality to be present in all antiepileptic drugs, including those not shown here.
|Carbamazepine||Carbatrol, Equetro, Tegretol, Tegretol XR|
|Valproate||Depakote, Depakote ER, Depakene, Depacon|
The FDA said they were now working with the drug companies to ensure this new information is included in the product label and accompanying patient and doctor information sheets. They are expecting the information to apply to all antiepileptic drugs and not just the ones given here.
An FDA advisory panel will also be taking up the matter at a forthcoming meeting.
Source: FDA News.
Written by: Catharine Paddock, PhD