Medicines used to treat epilepsy and psychiatric disorders may
raise the risk of suicidal thoughts and behavior, U.S. Food and
Drug Administration warned Thursday.
The angency analyzed 199 studies of 11 epilepsy drugs including
Pfizer Inc.'s Neurontin, Novartis AG's Tegretol and Abbott
Laboratories' Depakote
It found that of the 44,000 patients in the study -- 28,000
people taking the drugs and 16,000 the placebos, those who took the
drugs had about twice the risk of suicidal behavior compared with
those who took a placebo.
About 0.4 percent of patients given the drugs reported suicidal
thoughts or actions, compared with 0.2 percent of placebo patients,
the FDA said.
This means for every 1,000 patients, about two more drug-treated
patients experienced suicidal thoughts.
"We have just come to the conclusion that it's time to alert
heath-care providers," said FDA spokeswoman Sandy Walsh.
FDA said that the increased risk of suicidality is expected to
be present in all antiepileptic drugs, so it would work with drug
companies to make sure the latest data is reflected in their
prescribing information and labeling.
(Agencies via Xinhua News Agency February 1, 2008)