Rate of Preschool Kids Prescribed Antidepressants Skyrockets – Cong Investigates FDA

Rate of Preschool Kids Prescribed Antidepressants Skyrockets – Cong Investigates FDA

Fri, 2 Apr 2004

A new survey by Express Scripts found the rate at which American children are prescribed antidepressants almost doubled (49%) in 5 years. The steepest unfathomable, medically unsupportable, increase–64%–was among preschool children. This is evidence of a violation of the physician’s oath: First, Do No Harm.

Antidepressant drugs have not shown evidence of a benefit when tested in children 6 to 18, but the drugs have been shown to pose severe risks of harm for some children and adults. For example, a twofold increased suicide risk for children taking an antidepressant compared to those given a placebo.

Since June, 2003, GlaxoSmithKline discloses to 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%. See: http://emc.medicines.org.uk/emc/industry/default.asp?page=displaydoc.asp&documentid=2057

Given the unfavorable risk / benefit ratio, doctors who prescribe antidepressants for children should be subject to malpractice. Medically unsupportable use of antidepressants in children is nothing short of child abuse.

The serious health hazards for children is a consequence of the undue influence of the drug industry on medical practice. This industry’s inordinate influence extends to the media which is disseminating industry’s misleading advertisements. The national media has lent the appearance of legitimacy to industry’s unsubstantiated false claims about the safety and efficacy of drugs by repeating such claims in news reports.

The influence of the drug industry at the FDA is demonstrated by FDA’s failure to (at 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 embargoed a report by its own medical officer that corroborates the fact that the clinical trial evidence showed a twofold suicidal risk for children who had been prescribed an antidepressant in company controlled clinical trials.

CBS evening News and the San Francisco Chronicle reported that two Congressional committees-the House Energy & Commerce subcommittee on Investigations, and the Senate Finance Committee–are investigating the FDA cover-up. See: FDA Mum On Suicidal Side Effects? Sharyl Attkisson http://www.cbsnews.com/stories/2004/03/30/eveningnews/main609491.shtml

See: Lawmakers open probe of FDA: Agency accused of barring safety data on antidepressants, by Rob Waters, SAN FRANCISCO CHRONICLE Wednesday, March 31, 2004. http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2004/03/31/MNGRT5U12C1.DTL

Contact: Vera Hassner Sharav
Tel: 212-595-8974

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April 02, 2004 12:05 AM US Eastern Timezone

Preschoolers Lead Growth of Antidepressant Use, Study Reveals

ST. LOUIS–(BUSINESS WIRE)–April 2, 2004–The use of paroxetine and other antidepressant medications continues to grow by about 10% annually among children and adolescents, according to a study published in the April issue of Psychiatric Services. The study profiles trends of prescription antidepressant use in children and adolescents using prescription claim information from a random, nationwide sample. The study by Express Scripts examined antidepressant use among approximately two million commercially-insured, pediatric beneficiaries 18 years and younger from 1998 to 2002. 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%. For the entire sample, antidepressant use increased from 1.6% in 1998 to 2.4% in 2002, a 49% increase. Over the course of the study, the growth in use was greater among girls (68%) than boys (34%) and, for each gender respectively, growth was higher among younger boys and older girls. “A number of factors acting together or independently may have led to escalated use of antidepressants among children and adolescents,” said Tom Delate, Ph.D., Director of Research at Express Scripts. “These factors include increasing rates of depression in successive age groups, a growing awareness of and screening for depression by pediatricians and assumptions that the effectiveness experienced by adults using antidepressant medications will translate to children and adolescents.” 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 paroxetine (also known as Paxil(R)), Prozac(R) and Zoloft(R). Use of paroxetine increased 113% and 91% in females and males, respectively, over the study period. The U.S. Food and Drug Administration (FDA) has recommended that paroxetine 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. xxx cut xxx More information about these and other studies are available at http://www.express-scripts.com/other/news_views/outcomes_research.htm .
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NJ Star-Ledger
More kids prescribed drugs for depression
Preschool rate rose the most, study says
BY ED SILVERMAN
Friday, April 02, 2004

The rate at which antidepressants were prescribed to children rose about 10 percent annually between 1998 and 2002, with preschoolers accounting for the sharpest increase, according to a new study.

The study, which looked at prescriptions written for some 2 million pediatric patients nationally, found 2.4 percent were prescribed antidepressants in 2002, up from 1.6 percent five years earlier. That amounts to a 49 percent increase in the number of people under 18 prescribed antidepressants, according to the study in Psychiatric Services, a medical journal published by the American Psychiatric Association.

Among children 5 and under, the increase was even higher, with antidepressant use among girls doubling and among boys rising by 64 percent. Overall, the increase was highest among girls: 68 percent, compared to 34 percent among boys.

The growth in prescriptions written for children occurred even though 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 — after the rise in juvenile prescriptions began.

The findings come amid a widening controversy over antidepressants and alleged links to suicidal behavior and thoughts, especially among children. Last month, the Food and Drug Administration asked drug makers to add explicit warnings to their product labeling.

“This adds to the data showing many children are using these drugs,” said Tom Delate, research director at Express Scripts, a pharmacy benefits manager that conducted the study. “The safety and efficacy have to be examined more closely. This may add some impetus.”

He cited off-label use as the reason more children are prescribed the drugs. Off-label use refers to a common practice among doctors to write prescriptions even though regulators have not approved a medicine for a specific use.

Many doctors and families contend antidepressants have saved lives. This argument is also cited by drug makers, which deny their pills, including Zoloft, Paxil and Effexor, lead to suicide. The manufacturers include Wyeth, GlaxoSmithkline, Eli Lilly and Pfizer.

Last year, though, British authorities warned doctors not to prescribe the drugs, except for Prozac. They pointed to newly disclosed data showing one drug, Glaxo’s Paxil, wasn’t effective and could increase the risk of suicide.

Last week, two congressional committees launched a probe into the FDA’s handling of the controversy. They want to know why the agency didn’t take more action, such as urging doctors not to prescribe the pills.

The committee also wants the FDA to explain why one of its own medical reviewers was prevented from presenting data at a February hearing convened to explore safety risks. The hearing garnered national publicity after many parents testified their children committed suicide after taking an antidepressant.

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.

“Frankly, I call this child abuse,” said Vera Sharav of the Alliance for Human Research Protection, a consumer advocate. “There is no medical justification for putting preschoolers on such drugs. And there’s nobody protecting the children. It’s just a free-for-all.”

Ed Silverman can be reached at (973) 392-1542 or esilverman@starledger.com

Copyright 2004 The Star-Ledger.

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