As someone who has a close relative who is a doctor, and works in a busy doctor's office doing their IT work, ALWAYS check the dosage and ALWAYS ask questions. If they don't want to answer, get another doctor.
ith Addison wrote: >http://www.latimes.com/news/nation/reports/fda/lat_serzone001220.htm > >Wednesday, December 20, 2000 > >A Girl Is Given an Adult Medicine and She Pays a Heavy Price >Serzone: Company hasn't published study of effect on children. > >By DAVID WILLMAN, Times Staff Writer > >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. >BRIAN WALSKI / Los Angeles Times > 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." > >_______________________________________________ >Biofuel mailing list >Biofuel@sustainablelists.org >http://sustainablelists.org/mailman/listinfo/biofuel_sustainablelists.org > >Biofuel at Journey to Forever: >http://journeytoforever.org/biofuel.html > >Search the combined Biofuel and Biofuels-biz list archives (50,000 messages): >http://www.mail-archive.com/biofuel@sustainablelists.org/ > > _______________________________________________ Biofuel mailing list Biofuel@sustainablelists.org http://sustainablelists.org/mailman/listinfo/biofuel_sustainablelists.org Biofuel at Journey to Forever: http://journeytoforever.org/biofuel.html Search the combined Biofuel and Biofuels-biz list archives (50,000 messages): http://www.mail-archive.com/biofuel@sustainablelists.org/
