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New Antipsychotics Create Risks for Children and Teens

Sep 16, 2008 | Parker Waichman LLP

A new government study states that medicines most often prescribed for schizophrenia in children and adolescents are no more effective than older, less expensive drugs.  Also, the newer atypical antipsychotics are more likely to cause harmful side effects.  The authors suggest treatment standards be updated to include some older medications.  About one million children and teenagers are treated for schizophrenia.

Meanwhile, prescription rates for atypicals have increased more than five-fold for children over the past 15 years and are also being used to control outbursts and aggression in children with a wide variety of diagnoses representing about 80 percent of the prescriptions written for maladies such as autism, ADHD, bipolar disorder, depression, and anxiety, despite the drugs’ serious side effects.  Some uses are off-label, or not approved by the Food and Drug Administration (FDA).

The study compared two of the newer atypicals—Zyprexa from Eli Lilly and Risperdal from Janssen—against an older medication and found all three relieved schizophrenia symptoms such as auditory hallucinations in many of the young patients; however; half of the children stopped taking their drug.  Children stopped their medications within two months, either because it had no effect or was causing serious side effects, like rapid weight gain.  The children receiving Zyprexa gained so much weight that a government oversight panel monitoring safety ordered that they be taken off the drug.

The study was funded by the National Institute of Mental Health and is considered the most intense trial of atypical use in this sector of the population.  Approximately three million Americans suffer from schizophrenia and about 20 percent begin to show symptoms as children or teens.  Dr. Jon McClellan of the University of Washington, a co-author of new study and of current guidelines for treating childhood schizophrenia, said older schizophrenia drugs should now be considered as an alternative in some cases.  “Some of the children in this study gained 15 pounds or more in eight weeks,” Dr. McClellan said. “That’s as much as adults gain in a year on these medications.  Children are especially susceptible to these side effects, and this has broad implications across the board, for the use of these agents to treat any disorder.”

The researchers, led by Dr. Linmarie Sikich of the University of North Carolina, recruited 119 young people, ages eight to 19, who suffer from psychotic symptoms. The children received either Zyprexa, Risperdal, or molindone, an older drug used in blunt psychosis.  Neither the patients nor doctors knew which drug was being taken, but the researchers told the children and their parents that, if the medication was not working out, the family could switch to another.  After eight weeks, 34 percent of the children on Zyprexa, 46 percent on Risperdal, and 50 percent on molindone showed significant improvement, but many had gained a lot of weight:  About nine pounds for those in the Risperdal and 13 pounds in the Zyprexa group.  Both groups also showed changes in cholseterol and insulin levels that are diabetes risk factors.  Those taking molindone gained less than a pound, on average, and had little metabolic changes.


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