Dozens of relatives of children who either committed or attempted suicide told a panel convened Monday by the Food and Drug Administration that the youngsters’ actions were prompted by the antidepressant drugs that were supposed to help them.
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.
“The meager benefits don’t justify putting a child at risk,” said David Antonuccio, a professor in the department of psychiatry and behavioral sciences at the University of Nevada School of Medicine.
But Russell Katz, director of FDA’s division of neuropharmacological drug products, stressed that while tests have not shown clear benefits of the drugs over placebos, that is “not the same thing as showing them to be ineffective.”
The FDA has contracted with Columbia University to analyze the data on the suicidal behavior from the drug companies’ clinical trials. The agency plans to convene another meeting in August to address the issue, but Katz said that even then, the FDA still may not have a definitive answer about the risks of the antidepressants for children and teenagers.
It has been part of medical lore for decades that taking antidepressants may give a person the energy to follow through on suicidal impulses before there is a chance for the drugs to improve the patient’s mood. But both patients and parents on Monday told the FDA that, months after starting the drugs, children had become extremely hostile and experienced other forms of severely altered behavior.
In some cases, that behavior led to suicide or suicide attempts. In others it led to violent outbursts toward others, including homicidal tendencies.
Wyeth, the manufacturer of Effexor, warned doctors in September that tests showed its antidepressant caused an increased risk of suicidal behavior in children. Other companies have not sent out warnings.