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Antidepressants Get a Boost For Use in Teens
Despite Warnings on Labels, Study Says Benefits Outweigh Risks of Suicidal Tendencies
April 18, 2007; Page D1

In findings that doctors say should reassure parents about the use of antidepressants in young people, a new analysis concludes that the benefits of the drugs outweigh the risk of suicidal behavior. The report -- published today in JAMA, the Journal of the American Medical Association -- analyzed 27 studies of young people being treated with antidepressants for depression as well as obsessive compulsive disorder and anxiety disorders and found that the risk of suicidal thinking or behavior is smaller than previously thought. In particular, the study found that for every 100 patients being treated with the medications, fewer than one -- or 0.7% -- had an increased risk of suicidal thoughts. There were no completed suicides in any of the studies. The analysis also found that antidepressants were more effective than placebos in treating children and teens for major depression, obsessive-compulsive disorder and anxiety. These findings throw into question the mass of criticism that has been heaped on antidepressants in recent years over concerns that the drugs may cause an increased risk of suicidal thoughts and behaviors in young people. Those concerns culminated in a major regulatory change in 2004. The Food and Drug Administration began requiring drug companies to put tough "black-box" warnings on the drugs' labels to advise doctors and patients about the risks of suicidal behaviors in children and adolescents. In December, the FDA proposed extending such warnings to patients up to age 25. Now, given what researchers describe as the small risk, compared with clear benefits, some psychiatrists believe that the FDA should consider modifying or removing the black-box warnings. "I definitely think the language should be balanced" with information about the risk of suicide associated with depression itself, says Jeff Bridge, an epidemiologist and investigator at Columbus Children's Research Institute who was lead author on the study. Indeed, some critics of the black-box warnings have pointed out that suicidal tendencies are a risk of depression, so it may be hard to identify whether behaviors are due to a drug or to the underlying disease. And many psychiatrists have credited the availability of antidepressants with a drop in teen suicides. The rates of teen suicide had decreased starting in the 1990s, after antidepressants such as Prozac and Paxil -- powerful selective serotonin reuptake inhibitors -- hit the market. Since the FDA added the black-box warnings, there has been evidence of a drop in the use of antidepressants among kids. An analysis by Medco Health Solutions, a pharmacy-benefits manager, showed an almost 13% decline in the number of people age 19 and younger using an antidepressant in 2005 compared with 2004, along with a further 1.5% drop in 2006. The figures are based on a sample of about 2.5 million people in Medco's database. The company manages benefits for about 60 million Americans. Some experts say that this drop in the use of antidepressants among young people led to a rise in teenage suicides. From 2003 to 2004, the suicide rate for Americans under age 20 increased by 18%, according to the Centers for Disease Control and Prevention. The new report -- a so-called meta-analysis of existing research -- was led by researchers at Ohio State University. It examined data on 5,310 patients in the 27 studies, and found the risk of suicide behavior in young people to be half what the FDA had determined before requiring its black-box warning. The FDA had conducted its own analysis of 24 studies and about 4,400 patients, which found that two out of 100 patients had an increased risk of suicidal thoughts. The researchers on the new report said they included additional studies that came out last year and used a different statistical method from the FDA to compile the risk and benefit figures. In a statement, the FDA said "the risk of suicidal thinking and behavior is essentially the same by their, or our, calculations." The agency said it planned to keep the black box warning on the drugs, noting it urges doctors to carefully monitor patients starting antidepressant treatment and does not suggest avoiding the drugs. Like the FDA's analysis, the new study looked at several antidepressants, including Eli Lilly & Co.'s
Prozac, Pfizer's Zoloft, Wyeth's Effexor, GlaxoSmithKline PLC's Paxil and Forest Laboratories Inc.'s
Celexa. A spokeswoman for Wyeth said the company "welcomed" efforts like the JAMA analysis that look
at the benefits and risks of antidepressants. The other companies didn't return calls seeking comment late
The analysis of benefits confirmed what doctors say has been their experience with these drugs: Among 13 of the studies involving treatment for major depression, 61% of patients receiving antidepressants responded to the drugs, compared with 50% on placebo or fake pills. Six studies looked at obsessive-compulsive disorder and found that 52% of patients responded to antidepressants, compared with 32% in the placebo group. An additional six studies involved treatment for anxiety disorders and found 69% of patients on medication improved, compared with 39% in the placebo group. The new analysis, which was funded by the National Institutes of Health and the Robert Wood Johnson Foundation, also looked at the effects of the drugs by age and found that only Prozac was effective at treating children age 12 and younger for major depression compared with placebo. Indeed, Prozac is the only antidepressant that is FDA approved to treat major depression in children. Some drugs, such as Zoloft, are approved for other uses in children, such as treating obsessive-compulsive disorder. Many experts believe that the tough FDA warnings on the medications are discouraging families from getting needed treatment for children and adolescents. "The take-home question is what is the risk to your child of not taking the medicine," says Harold S. Koplewicz, founder and director of the New York University Child Study Center. He compared the risk of not giving a depressed child or teenager an antidepressant with not giving a child a vaccine. "We know that measles and mumps are not always deadly, but we don't want our children to have these diseases," he said. "But with depression, we absolutely know it can be lethal." And some parents say that antidepressants can make a huge difference in the health of a child. Sherri Walton's daughter, Jordan, suffers from obsessive compulsive disorder and had been taking an antidepressant, Luvox, since she was 7 years old. But a few years ago, when she was 13, Jordan became severely depressed and told her parents she no longer wanted to dance, go to school or live. Mrs. Walton took her back to the child psychiatrist who tweaked her medications for several months, eventually settling on Prozac. She gained about 25 pounds but her depression lifted almost immediately and her OCD symptoms stayed in check. Mrs. Walton, who took her daughter to Washington to testify before the FDA when the agency was holding its hearings on antidepressant use in children, says, "I wanted them to know that these antidepressants literally saved her life." Psychiatrists are quick to point out, however, that drugs alone are not the answer. "This study confirms the general consensus that these medications can be an effective component of treatment for children and adolescents with depression and other psychiatric disorders," says David Fassler, child and adolescent psychiatrist and clinical professor of psychiatry at the University of Vermont, in Burlington, Vt. But he cautioned: "It should only be used as part of a comprehensive treatment plan that is individualized to the needs of the child and the family." Write to Elizabeth Bernstein at [email protected] and Jennifer Corbett Dooren at
[email protected]


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