The US drug safety regulator Friday warned physicians that drugs used in treating epilepsy, migraine headaches and other conditions carry an increased risk of suicidal thoughts and behavior.
Patients given antiepileptics had twice the risk of suicidal thoughts and behaviour (0.43 percent) compared with patients given a placebo (0.22 percent), the Food and Drug Administration (FDA) said in a statement on its website.
AdvertisementThe risk corresponds to about two more patients per 1,000 in the drug treatment groups becoming suicidal than in the placebo groups, the FDA said.
"FDA will be working with manufacturers of marketed antiepileptic drugs to include this new information in the labeling for these products," it said.
The FDA fielded data starting in 2005 from some 200 studies done with 11 antiepileptics, some of which have been on the market for decades.
The analysis included 27,863 patients in drug treatment groups and 16,029 patients in placebo groups. There were four suicides among patients in the drug treatment groups and none among patients in placebo groups.
There were 105 reports of suicidal thoughts or behavior in the drug-treated patients and 35 reports in placebo-treated patients.