Thursday, December 28, 2000

Norwood girl feels health compromised


Suit alleges antidepressant led to liver failure, transplant

By David Willman
Los Angeles Times

        NORWOOD — When a hospital psychiatrist prescribed an antidepressant called Serzone for their 15-year-old daughter, Jimmie and Brenda Robinson assumed it was safe.

        The episode in February 1997 haunts them — Alissa Robinson nearly died after taking Serzone. After suffering liver failure and undergoing a transplant, she now faces a lifetime of uncertain health and worry over how she will pay for her care.

        Serzone, it turns out, was not intended for children or adolescents, and the label said its safety and effectiveness “have not been established” among the young. However, when FDA officials approved Serzone in December 1994, they suspected its use would not be confined to adults.

        “Since it is likely that (Serzone), once marketed, will be used in children and adolescents ... we ask that you commit to conducting, subsequent to approval, studies in these populations in order to provide the safety and efficacy data needed to support such use,” wrote an FDA administrator, Dr. Robert J. Temple, in a Nov. 7, 1994, letter to Serzone's manufacturer, Bristol-Myers Squibb Co.

        The company agreed to conduct the research, among patients age 7 to 17, and to report the results to the FDA. But nearly six years later, no results have been made public. Doctors may continue to lawfully prescribe it.

        A spokeswoman for Bristol-Myers said it hopes to report results to the FDA “in the early part of 2002.”

        In an interview at the family's home, Brenda Robinson said she was unaware that the FDA had not endorsed Serzone's use in adolescents.

        “That comes as a big surprise,” Brenda Robinson said. “If it's an adult medicine, why did (the doctors) give it to her? ... These drugs should be tested for the people they're going to be used in.”

        When specialists at Children's Hospital Medical Center admitted Alissa on June 12, 1997, they found she was suffering liver failure. Alissa was placed on a waiting list for a transplant.

        The morning of June 14, the Robinsons said, one of the doctors told them that Alissa, by then in a coma, could die within days unless a donor organ became available.

        On June 16, Alissa underwent the transplant.

        Just in the last year, Alissa was twice hospitalized: Three days because of a bug bite that became infected; more recently for surgery to repair a rupture in her transplant incision.

        “It's destroyed her for life; it's destroyed us,” said Jimmie Robinson, a machinist.

        The family is suing Bristol-Myers in state court, alleging that Serzone is a defective product.

        The company declined comment. Other named defendants include Good Samaritan Hospital and two doctors, including the psychiatrist who prescribed Serzone to Alissa. All of the defendants are contesting the lawsuit.

       



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