GlaxoSmithKline Settles Drug Case

New York Attorney General Eliot Spitzer and GlaxoSmithKlineGSK on Thursday announced a settlement in which the U.K.-based drugmaker agreed to release previously unpublished data about the safety and effectiveness of the antidepressant drug Paxil.

The settlement comes after Spitzer sued the company in June, alleging that since 1998 it had committed "repeated and persistent fraud" by "concealing and failing to disclose" information to doctors about Paxil's impact on children.

The company said that although the charges in Spitzer's suit "are unfounded," it had agreed to pay the state $2.5 million "to avoid the high costs and time required to defend itself in protracted litigation."

Paxil hasn't been approved by the Food and Drug Administration for children, and this prevents the company from marketing the drug as a treatment for them. Federal law, however, does allow doctors to prescribe the drug for children. What is called "off-label use" practice applies to any drug approved by the FDA.

The agency has been investigating the prescribing of antidepressants by doctors to youngsters, and an FDA advisory committee will conduct two days of hearings about antidepressants and children next month.

One key issue is determining whether antidepressants increase the risk of suicidal thinking and/or behavior among adolescents and children for whom these drugs are prescribed. The FDA issued health advisories in March 2004, October 2003 and June 2003 concerning children and antidepressants. After reviewing reports on 10 drugs, including Paxil, the agency said earlier this year that "it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior."

A new study commissioned by the FDA and conducted by Columbia University in New York, however, presents results that are "suggestive of an increased risk of suicidality for some of these [antidepressant] drugs," the FDA said last week in announcing the advisory committee meeting.