Epilepsy drugs are associated with a higher risk of suicidal thoughts and behaviour, US drug reviewers said in an analysis that was recently released and mirrored earlier findings.
"The effect appears consistent among the group of 11 drugs" that were reviewed, according to a summary from statistical reviewers at the Food and Drug Administration. There were about two more cases per every 1 000 patients given the drugs instead of a placebo, the FDA staff said in a review.
The findings are similar to data released by the FDA in January, agency spokeswoman Sandy Walsh said.
Agency officials have said they are working with drug makers to add information about the suicidal behaviour risk to the prescribing instructions for the drugs.
Drugs to prevent epileptic seizures
Epilepsy is marked by seizures stemming from abnormal electrical activity in the brain, causing involuntary movement or behaviour. Drug treatment is given to prevent seizures.
The FDA staff reviewed 199 trials involving about 44 000 patients who were given an epilepsy drug or a placebo. Some of the medicines also are approved for depression, migraines and other conditions.
Four patients given drug treatment committed suicide, compared with zero who got a placebo, the FDA staff review said. Overall, about 0.4 percent of drug-treated patients reported suicidal thoughts or actions, compared with 0.2 percent of placebo patients.
In January, the FDA said all patients taking epilepsy drugs should be closely watched for behaviour changes that could indicate suicidal thoughts or behaviour or depression. – (Lisa Richwine/Reuters Health)
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