Rate of Children Prescribed Antidepressants Explodes

The rate of increase of depression among children is 23% according to a Harvard University study reported in Harvard Mental Health Newsletter, February 2002.

There is continued controversy over antidepressants because of alleged links to suicidal behavior and thoughts, especially among children. The Food and Drug Administration has asked drug makers to add explicit warnings to their product labeling.

Since June of 2003, GlaxoSmithKline discloses on the UK Seroxat/Paxil label: "In common with other selective serotonin reuptake inhibitors, withdrawal symptoms have been reported on stopping treatment. Dizziness, sensory disturbance (e.g. paraesthesia), anxiety, sleep disturbances (including intense dreams), agitation, tremor, nausea, sweating and confusion have been reported following abrupt withdrawal of Seroxat." "The risk of drug withdrawal syndrome is 25%.Ē

The influence of the drug industry at the FDA is demonstrated by FDA's failure to, at the very least, issue warning labels that inform physicians and parents that these drugs are not safe nor demonstrably more effective than a placebo. Instead, the FDA has blocked a report by its own medical officer that backs up the fact that clinical trial evidence showed double the suicidal risk for children who had been prescribed an antidepressant in company controlled clinical trials.

A study conducted by Express Scripts (a pharmacy benefits manager) examined antidepressant use among approximately two million commercially-insured, pediatric patients nationally 18 years and younger from 1998 to 2002. This study found 2.4 percent were prescribed antidepressants in 2002, up from 1.6 percent five years earlier. That amounts to a 49% increase in the number of people under 18 prescribed antidepressants, according to the study published in Psychiatric Services, a medical journal published by the American Psychiatric Association. The fastest growing segment of users were found to be preschoolers aged 0-5 years, with use among girls doubling and use among boys growing by 64%. Growth was higher among younger boys and older girls.

Throughout the five-year period of the study, selective serotonin reuptake inhibitors (SSRI's) were the most commonly dispensed antidepressants, while tetracyclics were the least. SSRI's include known as Paxil, Prozac and Zoloft. Use of SSRIís increased 113% and 91% in females and males, respectively, over the study period. The U.S. Food and Drug Administration (FDA) has recommended that SSRIís not be used in children and adolescents because, among youths, its efficacy has not been established for depression and its use is associated with increased risk of suicidal thinking and suicide attempts. Of the SSRIs, only Prozac has been approved by the FDA for treating depression in children and adolescents. Prozac is the only drug approved for use in children with major depressive disorder, yet doctors are at liberty to, and in fact do, prescribe many others for pediatric use. Antidepressants, with the exception of Prozac, were never approved for anyone younger than 18. Prozac was approved as a treatment for children, but only two years ago, long after the increase in juvenile prescriptions began.

"There are two differing but not mutually exclusive viewpoints on the increased use of antidepressants in children and adolescents," said Tom Delate, Ph.D., Director of Research at Express Scripts. "One is the concern that antidepressants are being prescribed to youths without adequate information about their safety and efficacy in this population. The second is the presumption that advocacy work to identify and treat depression among children and adolescents has begun to pay off. We realize that the use of antidepressants among youths is a critical issue that requires additional research to better understand."

Consumer advocates, meanwhile, are stepping up calls for the companies that make antidepressants to release all unpublished clinical trial data. Drug makers aren't required to disclose this information, which critics say allows negative findings to remain suppressed.

In March 2004, Republican leaders from committees in the House and Senate opened inquiries into whether officials of the Food and Drug Administration prevented an FDA medical officer from presenting a safety review on antidepressants and suicidal behavior by children to an agency advisory committee in February 2004.

According to CBS New Correspondent Sharyl Attkisson, from her March 30, 2004 report, The FDA assigned one of its respected medical officers, Andrew Mosholder, to look at studies of eight anti-depressants and thousands of troubled kids. In documents obtained by CBS News, there were twice as many suicide-related events in children who took antidepressants as those who got only sugar pills.

Medical officer Dr. Andrew Mosholder was not allowed to present his report to the advisory panel regarding the issue that several leading antidepressants appear to increase the risk of suicidal thoughts and actions among children. Mosholder's analysis is thought to be similar to the conclusion reached by British regulators, who in December issued a public health warning telling doctors to stop prescribing most leading antidepressants to children. The British warning noted that the drugs had not been proven effective in reducing depressive symptoms among young patients and appeared to increase the risk of suicidal behavior.

References for Article: Rob Waters Ė San Francisco Chronicle, March 31, 2004; Vera Hassner Sharav, ALLIANCE FOR HUMAN RESEARCH PROTECTION- April 2, 2004 and Ed Silverman, NJ Star- Ledge, St. Louis Business Wire April 2004.

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