FDA Links Antidepressants, Youth Suicide Risk
By Shankar Vedantam
Washington Post Staff Writer
Tuesday, February 3, 2004; Page A01
Federal regulators said for the first time yesterday that clinical trials of popular antidepressants such as Prozac, Paxil and Zoloft show a greater risk of suicide among children taking the drugs compared with those taking dummy pills.
Although only one of these drugs has been approved for the treatment of children with depression, doctors are prescribing them to hundreds of thousands of American children every year. The new Food and Drug Administration analysis of the trials is starkly at odds with repeated assurances by the U.S. psychiatric establishment that the drugs are very safe.
Regulators said the result of their review was identical to a British analysis, which prompted Britain in December to prohibit use of most antidepressants in children. Before taking any regulatory action, however, U.S. officials have requested a second analysis of the data by Columbia University researchers. The new review, which will reevaluate the descriptions of adverse effects suffered by children in the trials, is likely to be completed by summer.
Patients and impassioned families pleaded for more urgent action at a day-long meeting of an expert advisory panel yesterday. Dozens of parents, siblings and doctors from all over the country gave lengthy and moving testimony describing family members and patients who had committed suicide or had turned violent after taking the drugs.
"We were told that Paxil and Prozac were wonder drugs," said Glenn McIntosh of Austin, whose daughter Caitlin, 12, hanged herself with shoelaces weeks after being started on Paxil and then being switched to Zoloft. "We were lied to."
Regulators acknowledged the demands of the grieving families but said a mistake in either direction in issuing new guidelines could have terrible consequences. Most doctors believe the drugs, collectively known as selective serotonin reuptake inhibitors, or SSRIs, save the lives of many depressed children; top researchers have warned of dire consequences if their use in children is banned.
Although only Prozac has been specifically approved for use in children, doctors are legally allowed to prescribe the drugs for any patient.
One company, Wyeth, has warned American doctors not to prescribe its drug Effexor to children. Gary Cheslek of Vicksburg, Miss., who said his son Justin hanged himself after taking Paxil, noted that the data that prompted Wyeth's warning had been available for years. Many families questioned why neither the company nor the FDA had acted earlier.
On a day of high drama at the Holiday Inn in Bethesda, dozens of families accused the agency of turning a blind eye to the problem. Some said their children had been helped.
"My children lead full lives because of SSRI medicines," said Suzanne Vogel-Scibilia, who said two of her children had been under psychiatric care. Vogel-Scibilia, a member of the National Alliance for the Mentally Ill, an advocacy group, said, "I shudder to think of what would happen to them if these medicines were not available."
© 2004 The Washington Post Company