The agency is finalizing plans to add suicidal behavior to the labels of 11 epilepsy drugs, reflecting concerns that the meds are also widely used for other maladies, such as chronic pain, The Wall Street Journal reports.

“We are working on the labeling changes that we want to get to the companies,” Russell Katz, director the FDA’s neuropharmacological drug division, tells the paper, which adds that several drugmakers believe the FDA may even propose the changes before a July 10 advisory committee meeting.

Katz defended the agency’s decision earlier this year to alert doctors and patients to a potential link to suicidal behavior, despite concerns from some drugmakers about the small increase in risk drawn from the FDA’s analysis and the potential impact on drug revenues, the paper writes.

“Everything points in the direction of an increase in what we call suicidality,” Katz tells the paper. He was referring to the FDA’s combined analysis of 199 clinical trials that included 43,892 patients. The results showed a “trend across the board” in differences in behavior between patients who took a placebo and those who took one of the 11 medications, the Journal writes.

Pfizer disputed the FDA’s analysis in a forum this week sponsored by the Epilepsy Study Consortium in New York, but the Journal writes that the drugmakerr is becoming isolated from others, which have decided not to challenge the FDA.

In fact, the paper writes that Pfizer is bewildered the FDA won’t meet to hear its concerns, which hinge on the rarity of the events seen and the fact that its two affected meds don’t work in the same way as the others on the list. “We’re not fighting [with the FDA], but we’re alone in our insistence that our data doesn’t show a risk,” spokesman Jack Cox tells the Journal.

A label addition citing potential suicide risks could affect Pfizer more than other companies, because its Lyrica med is relatively new and brought in $1.8 billion in sales last year, the Journal notes. The vast majority of that total, according to Pfizer, came from patients with nonepilepsy disorders, such as chronic pain and fibromyalgia, a mysterious pain condition.

Other meds on the list have lost their patents or are near the patents’ expirations, the paper continues. The Pfizer tells the paper that Pfizer is more concerned about the accuracy of the FDA data than a financial hit, because the label change would affect all the drugs in the class equally.

Earlier this week, UCB, which makes Keppra, and Glaxo, which makes Lamictal, made presentations to the consortium, and the Journal writes that they focused on how to track psychiatric disorders in future studies of patients with epilepsy or depression, since they already are at risk for suicidality. “Neither company made the same case” or objections as Pfizer did, Katz tells the paper.

One of Pfizer’s medical experts, Steve Romano, earlier this week told the Journal that Lyrica is a very different kind of drug from most anticonvulsants, and the FDA data showed Lyrica accounted for only 6.3 percent of the total 142 suicidal events. Two other drugs were linked to much-higher numbers of suicidal disorders.

However, the FDA intends to apply any label change to the whole class of drugs, the paper writes. Some of the drugs may have accounted for higher or lower numbers of suicidal incidents, but, as a whole, they exhibited “the same upward trend” for an increased risk of such behavior, Katz says.

Glaxo’s medical director, Ronald Krall, told the paper he doesn’t think the FDA’s findings were “conclusive” but Glaxo is cooperating with the FDA on wording changes. Glaxo approached the FDA this year to volunteer changes regarding possible suicidal-behavior risks linked to Lamictal, the Journal adds and that the FDA asked Glaxo to wait until labeling changes for the entire class are ready.

Abbott also told the Journal it disagrees with the FDA’s analysis but is moving forward with the agency on drug-label changes.