ANTI-DEPRESSANTS FDA: Kids' suicide risk rises with some drugs

An advisory panel heard testimony from both sides of the debate.
WASHINGTON POST
WASHINGTON -- Federal regulators said for the first time that clinical trials of popular anti-depressants 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 Monday 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 that country in December to prohibit use of most anti-depressants 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 re-evaluate the descriptions of adverse effects suffered by children in the trials, will likely be completed by summer.
Families' testimony
Patients and impassioned families pleaded for more urgent action at a daylong meeting of an expert advisory panel Monday. 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 12-year-old daughter Caitlin hanged herself with shoelaces weeks after being started on Paxil and then 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 think 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.
Company's warning
One company, Wyeth, has itself 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 hotel in Bethesda, Md., 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 advocacy group National Alliance for the Mentally Ill, said, "I shudder to think of what would happen to them if these medicines were not available."
David Fassler, a psychiatrist who testified at the hearing on behalf of the American Psychiatric Association, said in an interview, "Hearings like this frighten parents and make it less likely they will bring their kids in for treatment."
Fassler and other leaders in American psychiatry say large numbers of depressed children are untreated. "Medications can be lifesaving, but medications alone are not the answer," he said.
Increasingly, however, American doctors have come to rely on drugs. Officials said yesterday that 2.1 million prescriptions for anti-depressants were written for children in 2002.
Shortcomings of trials
A key problem, both critics and advocates said, is that the clinical trials conducted by drug companies were not designed to answer the questions that are now being raised. FDA officials are trying to make comparisons among studies that used different terms to describe suicidal tendencies and different measures of what constitutes a suicidal thought or attempt.
Researchers at Columbia will study narrative reports of adverse effects and reclassify them according to uniform criteria. The FDA asked nine drug makers to submit details of every adverse report suffered by about 4,000 children across 25 trials. The Columbia group will not be told in advance how the companies classified the cases.