In a push for a black box warning on epilepsy drugs, the U.S. Food and Drug Administration underlined the risk of suicide, associated with all drugs used to treat seizures. The FDA found, after analyzing 200 cases, that those taking the drugs face twice the risk of people who are not on anti-epileptic drugs.

However, FDA Director of Neurology Products Russell Katz said that there is no explanation as to why this happens, but reminded there is strong empirical evidence in this direction. Pfizer's Lyrica and GlaxoSmithKline's Lamictal are the drugs most commonly used.

Interestingly enough, its expert advisory panel refused the Food and Drug Administration (FDA) proposal to place the black box warning. The problem is that critics allege warnings are driving patients away from necessary treatment. FDA's expert advisors said there was insufficient evidence to support stark warnings that could discourage patients and their doctors from using them.

The FDA is not required to follow the recommendation of its expert panel, but it usually does. Out of about 43,000 patients studied, about four patients on the drugs and none taking placebo completed suicide, while 30 patients on anti-epileptic drugs attempted to kill themselves, compared to only six of the placebo group.

Despite rejecting the black box warning, the expert panel indeed acknowledged these apparent risks and suggested sending a medication guide to doctors detailing the suicide risks. The actual vote count was 20-0 that the drugs do increase the chance patients will consider suicide, while the experts voted 14-4 against the proposal to add bold warnings to the medicines' prescribing information.

Reuters reports that Pfizer maintains its drug is safe, while Glaxo said the information gathered by the FDA should make it into the drugs' labels. More than 10 million Americans took FDA-approved epilepsy drugs in 2007.

Epilepsy, a chronic neurological disorder, is characterized by recurrent unprovoked seizures, caused by abnormal, excessive or synchronous neuronal activity in the brain. There are five drug pathways which can alleviate epilepsy symptoms: sodium channel blockers, calcium channel blockers, drugs that potentiate the effect of GABA and drugs which decrease the excitatory transmission.