Paxil Claim for 1997 Suicide Clearly Conflicts with Federal Regs, Judge Says

SACRAMENTO, Calif. - Paxil maker GlaxoSmithKline could not have known prior to 1997 that the antidepressant posed an increase suicide risk to pediatric patient, and federal law preempts any state law claim that the drug's FDA-approved label should have included such a warning at the time, a judge has ruled. O'Neal v. SmithKline Beecham Corp., et al., No. 06-1063 (E.D. Calif.).

Judge Frank C. Damrell Jr. of the U.S. District Court for the Eastern District of California held Jan. 30 that without any clinical confirmation that Paxil posed a suicide risk to younger populations, any change to its label indicating …