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Federal drug experts criticize over-use of antipsychotics in children

The New York Times reported today that drug regulators must do more to warn physicians about the over-use of Risperdal, Zyprexa and other antipsychotics in children.  It noted that 389,000 children and teens were treated in 2007 with one of five atypical antipsychotics. A quarter million of these kids were under the age of 12, and frequently the treatment was for attention deficit disorders.

Risperdal, for example, was not approved for this use, and it carries significant risks including substantial weight gain, metabolic disorders and muscular tics that may endure permanently.  The scientists UNANIMOUSLY rejected the FDA's plan to simply warn and monitor the use of these drugs because not enough is being done to discourage the "off-label" use of the drugs for less serious medical problems such as ADD.  Other medicines in this class include Seroquel, Abilify and Geodon.

Experts say that the prescription of these drugs to children has increased five-fold in the past 15 years, in part in an effort to control physical outbursts and aggression, for example.  Because of their metabolism and low body weight, children are more susceptible to side-effects and complications, and these drugs were not thorougly tested for use with children.  One of the motivating factors in the increased use of these drugs to treat children is the diagnosis of "pediatric bipolar disorder".  The latter diagnosis has been pushed particularly hard by Dr. Joseph Biederman at Harvard:  federal investigators recently challenged his ethics and credibility when they discovered that he had failed to disclose more than 1.4 million dollars in outside income from the manufacturers of antipsychotic medications.

Data on childhood use of Risperdal shows that from 1993 through the first quarter of 2008, 1200 children suffered serious complications, including 31 who died.  At least 11 of the fatalities involved kids who were being treated "off-label" [i.e. for non-FDA approved uses].  The FDA says that no long-term studies have been done to test the safety of these drugs, and the scientists interviewed by the New York Times offered their opinion that related neurological complications are often unrecognized and under-reported.

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