Accutane Label Didn't Need Additional Suicide Warning, Judge Rules

TAMPA, Fla. - Hoffman-La Roche Inc. was not required to include in its Accutane label any heightened psychiatric warning about suicides occurring "spontaneously" or without any prior signs of depression in those taking the drug, a federal judge has ruled. Stupak v. Hoffman-La Roche Inc., et al., No. 05-926 (M.D. Fla.).

In awarding summary judgment to Hoffman-La Roche on Aug. 17, Judge James S. Moody held that the company cannot be held liable for failing to adequately warn patients and their physicians of the risks of depression and suicide associated with Accutane use. Specifically, the judge held that Hoffman-La Roche's …