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 while 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 for any purpose they deem appropriate.
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."
Serzone has been an important drug for Bristol-Myers, generating sales of $1.1 billion through October, according to IMS Health, an information services company.
Eighteen cases of liver failure involving Serzone patients were reported to the FDA from 1996 to June 2000. The product labeling was changed, subsequent to Alissa's use of Serzone, to note "rare reports of liver . . . failure, in some cases leading to liver transplantion and/or death."
According to an article coauthored by one of Alissa's physicians and published Feb. 16, 1999, in the Annals of Internal Medicine, Serzone was "the most likely cause" of her liver failure.
For now, Alissa and her parents are left to wonder what her life might have been if she had not taken the drug.
Brenda Robinson points to the maroon "puke bucket," Alissa's constant companion in the spring of 1997. By Memorial Day weekend that year, three months after going on Serzone, Alissa was nauseated and vomiting twice or more daily, according to medical records and interviews. Her eyes and skin had yellowed, a sign of jaundice.
When specialists at Children's Hospital Medical Center in Cincinnati admitted Alissa on June 12, they found she was suffering liver failure. Alissa was placed on a waiting list for a transplant. Amid the gantlet of tests and diagnostic procedures, Alissa's flowing, auburn hair was cut, her head shaven.
"That was the worst part," Brenda Robinson recalled. "When she woke up bald . . . she went to pieces."
The morning of June 14, Jimmie and Brenda said, one of the doctors told them that Alissa, by then in a coma, could die within days unless a donor organ came available. Brenda, an upbeat woman who works in the auditor's office at the local city hall, lived at her daughter's bedside.
On June 16, Alissa underwent the transplant. "She came this close to dying," Brenda recalled, struggling with her emotions at the memory.
Alissa was reluctant to discuss the difficulties. But when an earlier portrait of her was brought to the family's kitchen table, she said evenly, "That was in my pretty days."
Alissa's father worries that no employer will offer her health insurance, that she will unable to pay for essential prescriptions and care. 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 in this blue-collar suburb of Cincinnati.
The family is suing Bristol-Myers in state court, alleging that Serzone is a defective product and "unreasonably dangerous."
The company declined to comment on the litigation. Other named defendants include Good Samaritan Hospital of Cincinnati and two doctors, including the psychiatrist who prescribed Serzone to Alissa. All of the defendants are contesting the lawsuit.
An FDA spokesman, Jason Brodsky, said the agency has within the last three years "issued a formal written request to Bristol-Myers Squibb to study [Serzone] for the treatment of depression in children ages 7 to 17."