Fwd: [SSRI-Research] Serzone: Company hasn't published study of effect on children.

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JustSayNo

Thu, 01 Jan 2004 23:14:30 -0500

[sSRI-Research] Serzone: Company hasn't published study of effect on

children.

 

Serzone: Company hasn't published study of effect on children.

A Girl Is Given an Adult Medicine and She Pays a Heavy Price

 

By DAVID WILLMAN, Times Staff Writer

http://www.latimes.com/news/nation/reports/fda/lat_serzone001220.htm

http://www.whale.to/drugs/serzone.html

 

Alissa Robinson, 18, looks out the front door of her family's Norwood, Ohio

home while her parents Jimmie and Brenda enjoy a warm autumn afternoon on

their front porch. Alissa underwent a liver transplant 3 years ago following

complications while taking the anti-depressant drug Serzone.

 

 

NORWOOD, Ohio--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. "