Drug companies are scrambling to try to convince FDA not to add warnings for suicidal behavior risks to a large class of epilepsy drugs also used widely for a variety of other conditions, "The Wall Street Journal" reported June 4.

On June 1, at a closed meeting of epilepsy researchers

and industry representatives in New York, FDA presented data that agency officials said show a statistically significant difference in suicidal tendencies for patients who have taken one of 11 epilepsy drugs that are on the market. However, the difference is quite small; the risk of suicidal behavior for patients on a placebo was 0.23% and for those taking one of the 11 drugs it was 0.37%.

Several companies at the forum held by the Epilepsy Study Consortium expressed concern to FDA that its analysis is flawed because it grouped the results of 199 previously completed clinical studies of the 11 drugs, some of which are very different. In addition, several of them are commonly used in combination. Three firms-GlaxoSmithKline, UCB and Pfizer--made presentations at the event.

Several executives said they left Monday's conference convinced that FDA may announce new warnings about suicidal behavior soon, according to two people who attended. The agency has scheduled an advisory committee meeting on the drugs for early July.

"We did not see a signal for suicidality at all in our data base," said Steve Romano, vice president-global health at Pfizer, which makes the drug Lyrica. He attended the meeting.

Drug makers and FDA find themselves increasingly at odds as the agency has recently responded to criticism by toughening product labels and turning down some of the industry's biggest hopefuls.

Pfizer is concerned that stringent FDA warning could cripple the brisk growth in sales of its anti-seizure drug Lyrica, which brought in $1.8 billion in sales in 2007 and was approved last year to treat fibromyalgia. Other epilepsy drugs are also used to treat chronic pain, migraines, anxiety and bipolar disorder.

Pfizer officials say they have been trying to get a meeting with the agency since late January when FDA unexpectedly said it had noted a link between the drugs and an increased risk of suicide.

Abbott Laboratories, whose sales of its Depakote epilepsy pill passed $1.2 billion last year, said its review of clinical trial data "shows no incremental risk of suicide-related events with Depakote." However, the company said it will work with FDA to implement any label changes it recommends.

Some epilepsy researchers worry that FDA is responding to pressure from Congress and public-interest groups because of a series of embarrassing drug problems in recent years.

"I think the FDA is overreacting," said Ilo Leppik of the University of Minnesota. Leppik, who has researched epilepsy treatments for 35 years, added, "This came out of the blue" this year. He said he believes FDA is acting quickly to label the epilepsy drugs because of the agency's late response in 2004 to concerns that popular antidepressants were linked to suicide among teenagers.

In October 2004, FDA required manufacturers of all antidepressants to add a "black box" warning about links to an increased risk of suicidal thinking and behavior in children and adolescents.

FDA is now doing "early warnings" of potential side-effect signals in the epilepsy drugs, said FDA spokeswoman Julie Zawisza. Earlier this year, the agency issued an early warning for suicidality about the popular allergy medicine Singulair.

Epilepsy patients are already at increased risk for suicide and depression. Frank Gilliam, M.D., an epilepsy specialist at Columbia University, said many studies have demonstrated this connection and one key investigation suggested that nearly 10% of epilepsy patients suffer severe depression.

"When the base rate is 9%, it's hard for me to see the importance of overemphasizing the .2% difference" between placebo-takers and epilepsy drug users, Gilliam said.