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FDA 2004 PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE WITH THE PEDIATRIC SUBCOMMITTEE OF THE ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DR. RUDORFER: Could we have speaker 27, please. Lorraine Slater
MS. SLATER: Informed parental consent is only possible as long as full disclosure is made by the pharmaceutical companies, the FDA, and the medical community.
How can you imagine I feel as Dominique’s mother knowing now that I was slowly poisoning my daughter every day as I was dispensing her antidepressant medication including Celexa and which she made her first suicide attempt after being on it for almost one month, and effects of the last medication she was on when she did commit suicide?
Yes, Dominique’s mind and behavior were slowly being altered to the point that she became very agitated, irrational, ultimately suicidal, because none of the so-called medical professionals acknowledged the drug’s role in her irrational and suicidal behavior or properly withdrew her from their suicidal effects.
Our lovely 14-year-old daughter is dead.
Dominique has been denied the unalienable right by her creator of the pursuit of life, liberty, and happiness. She will no longer be able to pursue her dreams of becoming either a computer software engineer, computer graphics engineer, or marine biologist, and someday an entrepreneur, she had hoped.
Gone, too, is our ability to be able to watch Dominique blossom into womanhood, as well as motherhood, as she expressed the desire to someday have five kids.
Now, we will never have the opportunity to continue sharing our lives with Dominique, whom we loved and cherished so much.
She was not only very intelligent, humorous, delightful, insightful, and innovative, she was also very caring and thoughtful. Dominique had a way of making others feel special and loved.
She touched so many lives. For example, Dominique made 1,000 paper origami cranes and sent them to Governor George Pataki of New York for the first anniversary of 9/11.
It was because of Dominique’s very loving and genuine nature that around 300 people showed up to her memorial service. They couldn’t believe that for someone who was so loving and caring, she would herself take her own life.
I submit to you today, ladies and gentlemen, that Dominique’s life was taken from her as a result of drug-induced psychosis and suicidal ideations, not to mention the probability of experiencing akathisia, extreme agitation. As a 14-year-old adolescent, her brain was experiencing the second largest growth period, and her hormones were unbalanced.
How can teenagers be allowed to be given antidepressants that were never approved for adolescent consumption, only for adults? How come the medical profession doesn’t fully disclose the possible harmful and fatal effects of medication as well as watch carefully for diverse effects on its adolescent population?
DR. RUDORFER: I am sorry that we are out of time, but thank you very much.
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Parents Blame Medicines for Suicides
Los Angeles Times
Relatives should have been told of a potential link between harmful impulses in children and antidepressants, they tell an FDA panel.
February 03, 2004|
Elizabeth Shogren | Times Staff Writer
The FDA is assessing whether there is a link between suicide in children and drugs such as Zoloft and Paxil, which are in a class of pharmaceuticals known as selective serotonin reuptake inhibitors, or SSRIs.
The British government announced in December that the drugs should not be taken by children because of the possible increased risk of suicide.
The FDA has taken a milder approach, alerting doctors in October about the reports of suicidal thoughts and suicide attempts among children in clinical tests of the antidepressants. The agency plans to analyze the data from 15 clinical studies of the drugs before deciding whether to prohibit doctors from prescribing them for children or to require that drug companies warn doctors of possible links to increased suicide.
“To err in either direction has significant consequences,” said Thomas Laughren, leader of the FDA’s psychiatric drug products team.The FDA has approved only one SSRI for treating children and adolescents — Prozac, which came on the market in the United States in 1988. Despite that, many doctors prescribe other SSRIs for their young patients. About 2.7 million children younger than 12 and 8.1 million adolescents between 12 and 17 took antidepressants in 2002, according to the FDA.Banning the drugs, if they do not present extra suicide risks, could rob children of medications that could help them. However, failing to ascertain that the drugs increase the risk of suicide could give parents false comfort that these drugs were safe.
But many of the parents and patients who testified Monday said that the FDA already had made a significant error by failing to warn parents that suicide was a risk.
“We are 100% convinced that Zoloft killed our daughter,” said Tom Woodward of North Wales, Pa. Woodward said his teenage daughter had hanged herself in July, seven days after starting the drug. She had never shown any violent or suicidal tendencies before taking the drug and had just scored 1,300 on the SAT, her father said.
“Instead of picking out colleges with our daughter, my wife and I were picking out a cemetery,” Woodward said.
“The FDA should be a zealous advocate of the public,” he said. But instead, it protects drug companies, he added.
Lorraine Slater said her 14-year-old daughter, Dominique, went from being a sightly depressed honor student to a suicidal young woman after their family doctor prescribed one of these drugs. Dominique was taking the antidepressant Effexor when she drowned herself last February in the Delta Mendota Canal near Patterson, in California’s Central Valley. Slater said she was unaware of the possible link between the drug and suicide until after her daughter’s death.
“Dominique’s life was taken from her as a result of a drug-induced psychosis,” said Slater, 38. “If we had known” about the reported risks, Slater said, “I don’t believe we would have let her be on Effexor. It’s too late for us; we hope it’s not too late for other families.”
But some parents urged the panel not to ban these drugs for children, saying that the medications have been very helpful.
Suzanne Vogel-Scibilia, a psychiatrist, has two children who take antidepressants.
“I shudder to think of their plight if these medications were not available,” said Vogel-Scibilia, who was speaking for the National Alliance for the Mentally Ill.
Some doctors who testified at the daylong meeting Monday stressed that the benefits to children who take the drugs do not outweigh the risks, because clinical tests have not shown them to be much more effective than placebos.