Epilepsy drugs used by millions of people may increase the risk of suicidal thoughts or behaviour, the Food and Drug Administration (FDA) has warned.
The FDA made the announcement after analysing almost 200 studies of 11 antiseizure drugs.
The studies tracked almost 28,000 people who were given the medications and another 16,000 who were given placebos.
Although suicidal thoughts or behaviour were very rarely reported, the FDA found drug-treated patients did face about twice the risk.
The research showed that 0.43% of drug-treated patients experienced suicidal thoughts or behaviour, compared with 0.22% of placebo-takers.
Overall, four people in the drug-treated groups committed suicide, but nobody in the placebo groups did.
Anti-seizure drugs are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.
The FDA found drug-treated patients were at increased risk no matter their diagnosis, but that the risk was highest for epilepsy sufferers.
The agency has now sent a letter to doctors advising them to “balance the risk with the patient’s need for the drug”.
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“So the balance of risk is probably to give the drug, but write a stern letter for your US lawyer. All-cause mortality should be the endpoint. Without treatment, how many epileptic patients would die from things like hypoxic injury or crashing their car? How many of these patients had some form of pre-existing brain damage that might predispose to suicide, but with treatment can live near-normal lives?” – Name and contact details supplied