Accutane maker warns of suicide danger in patients.

Based on reports that nearly two dozen people since 1989 have committed suicide while taking Accutane, a pioneering acne-treatment drug, its manufacturer and the FDA have strengthened the drug's warning label to alert doctors and patients to its possibly dangerous side effects.

In announcing its decision, the FDA noted that no cause-and-effect relationship has been established between Accutane and suicidal thoughts or actions of patients. The strengthened warnings are a precautionary measure, designed to alert physicians to the drug's potential danger, according to the agency and Accutane manufacturer Hoffmann-La Roche, Inc.

The revised "warnings" section of the label reads: "Psychiatric disorders: Accutane may cause depression, psychosis, and, rarely, suicidal ideation, suicide attempts, and suicide. Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary."

The revised "adverse reactions" section of the label reads: "Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy."

The Accutane label had included information about depression as a possible side effect since the drug came on the market in 1982, but the label did not mention potential suicidal tendencies among users.

The new label was triggered by Hoffmann-La Roche and FDA reports received through the FDA's MedWatch, a system designed to alert the agency and physicians to potential problems with medications or FDA-regulated medical products.

Twenty-three people have committed suicide while taking Accutane between 1989 and 1997, an FDA spokeswoman said, quoting the latest MedWatch figures.

Accutane is prescribed for patients--most often adolescents--who have cystic acne, a particularly severe form that does not respond well to traditional antibiotic therapy.

Hoffmann-La Roche spokeswoman Kellie McLaughlin said teenagers traditionally suffer from a higher incidence of depression, making it difficult to determine whether the drug causes depression among its users.

She added that the same hormones that contribute to the formation of acne can also contribute to depression. on the trampoline; landing improperly while on it; falling or jumping off the equipment, and falling on the trampoline springs or frame.

Ann Brown, head of the CPSC, has said that an outright ban on backyard trampolines is not necessary, but she urged manufacturers to stop including ladders with their products and to add or improve protections that would prevent injuries from the springs that support the jumping "mat." The agency also recommends that parents not allow children under age six to use trampolines and that older children be supervised on the equipment.

Bud Nichols, head of Jumpking, Inc., in Garland, Texas, the nation's largest trampoline manufacturer, said the injury statistics cannot be interpreted properly without understanding that trampoline sales skyrocketed during the years covered in Smith's study. He said that relative to the number of trampolines in consumers' backyards, the rate of injury has probably decreased rather than increased.

"The pediatrics group doesn't like us," Nichols said. "Since 1977 they have been saying that trampolines have no place in the backyard. Consumers clearly don't agree with them. They are the same group that wanted to ban baseballs from Little League. I don't believe there's any possibility that trampolines are going to get banned." y the Nationa