GlaxoSmithKline Settles Drug Case

The agency didn't identify the drugs. It also noted that "there remain inconsistencies in the results, both across trials for individual drugs and across drugs." Evaluating this data "represents a substantial challenge," the FDA said.

Meanwhile, the agency has asked drugmakers to change their drugs' labels to include "stronger cautions and warnings" about the need to monitor patients whose depression worsens or who talk about suicide. Among antidepressants, only Prozac is approved for children and adolescents for a condition called pediatric major depressive disorder. Zoloft and Prozac have been approved by the agency for treating obsessive-compulsive disorders in children.

Spitzer had accused GlaxoSmithKline of failing to disclose information about what he said were four negative tests on Paxil's effects on children and adolescents. The company, he argued, only released information on one test that showed mixed results. The unpublicized tests "suggested a possible increased risk of suicidal thinking and acts in certain individuals," Spitzer said Thursday.

"This settlement holds GlaxoSmithKline to a new standard of disclosure about studies concerning its drugs," Spitzer said. "By agreeing to release both positive and negative studies about the safety and efficacy of its drugs, GlaxoSmithKline has set an example for the entire pharmaceutical industry."

In its statement, GlaxoSmithKline noted that on June 10 it "voluntarily posted" on its corporate Web site "full study reports" of all company-sponsored tests of Paxil being given to children and adolescents. The company said it was acting "in response to public concern about the access of [Paxil] data in children and adolescents with depression." The company also said that on June 18 it had announced plans "that had been under way for some months" to create a clinical trial register that would provide Internet access to clinical trial data on its marketed products.

Spitzer's office said that under the settlement, the drug company will continue to post on a Web site the results of clinical studies regarding Paxil and adolescents and children.

"We are pleased that the attorney general believes the clinical trial register we have been developing will provide useful information to the medical and scientific community," said Mark Werner, GSK's senior vice president for U.S. legal operations.