Wednesday, October 28, 2009

Antipsychotic Drugs in Kids Linked to Weight Gain

Children and teens who took antipsychotic medicines in a study gained weight and developed increased blood-fat levels, possibly harming their future health, researchers in New York State said.

The subjects, taking the antipsychotic drugs for the first time, gained from 9.7 to 18.7 pounds (4.4 to 8.5 kilograms) after about 11 weeks of treatment, depending on which medicine they were given, the scientists said today in the Journal of the American Medical Association. Fifteen patients who didn’t stick with drugs or who declined to participate in the research gained less than half a pound on average.

The study was the largest to show how antipsychotic medicines affect the bodies of children taking the drugs for the first time, the researchers wrote. Many past studies of the drugs involved patients who had also used other treatments -- methodology that may have masked the extent of weight gain, according to an editorial published with the study.

“We were able to show all of these agents can cause quite a bit of body weight changes and body composition changes that are not beneficial to the health,” said Christoph Correll, the study’s lead author, in a telephone interview on Oct. 23.

“What we need to figure out is what are the long-term consequences in the lives of children,” Correll, who is a medical director at Zucker Hillside Hospital in New York City’s Queens borough and an associate professor of psychiatry at Yeshiva University’s Albert Einstein College of Medicine in the Bronx.

Metabolic Syndrome

Gaining weight and changes in blood sugars and fats can be precursors to metabolic syndrome, a group of risk factors linked to heart disease and diabetes, according to the research article. Weight gain, obesity and increases in cholesterol in children are linked to their adult risk of cardiovascular problems and cancer.

Patients in the study had been diagnosed with mood disorders, schizophrenia and disruptive or aggressive behavior. Their doctors had prescribed Abilify, made by New York-based Bristol-Myers Squibb Co.; Zyprexa, made by Indianapolis-based Eli Lilly & Co.; Seroquel, made by London-based AstraZeneca Plc, or Risperdal made by New Brunswick, New Jersey-based Johnson & Johnson.

Risperdal and Abilify are the only two antipsychotics approved for pediatric use. A panel of outside advisers to the U.S. Food and Drug Administration recommended in June that Seroquel, Zyprexa and New York-based Pfizer Inc.’s Geodon be cleared for pediatric use.

Impact in Children

The medicines, so-called atypical antipsychotics, were introduced for adults in the mid-1990s and marketed as having fewer neurological side effects than older drugs. The FDA has grappled with pediatric use for years because of concerns that weight gain, sleepiness and movement disorders reported as side effects in adults may be more pronounced in children.

U.S. sales of antipsychotic drugs reached $14.6 billion last year, the most for any class of medicines, according to IMS Health Inc. in Norwalk, Connecticut. Use of antipsychotic medicines by people younger than 20 years old has more than doubled since 2001, according to data compiled by Medco Health Solutions Inc. of Franklin Lakes, New Jersey.

The study reported today was conducted to determine if weight gain and other changes to the body were related to the start of a psychiatric illness or hospital admission, or to the medicines.

Prescribed for Behavior

Researchers at Zucker Hillside, and at the Feinstein Institute for Medical Research in Manhasset, New York, studied 272 people ages 4 to 19 who were prescribed the antipsychotic medicines for behavioral, mood or psychosis-related problems. The patients were followed for the first 12 weeks.

At about 11 weeks, those taking Zyprexa gained 18.7 pounds on average, compared with 13.4 for Seroquel, 11.7 for Risperdal and 9.7 for Abilify, the study showed.

“The extent and the rate of weight gain is remarkable,” said Christopher Varley, a professor in the psychiatry and behavioral sciences department at the University of Washington in Seattle, in a telephone interview on Oct. 23. “Realistically the kids were exposed to 11 or 12 weeks of medication. Some of them gained over 20 pounds.” Varley co-wrote the editorial in the journal that was published with the study.

Ten percent to 36 percent of the patients in the study became overweight or obese within 11 weeks of starting the medicine, the researchers said.

Cholesterol Increases

Those on Zyprexa had larger increases in cholesterol and blood sugars, according to the study. Those on Risperdal had rises in their levels of triglyceride, a type of fat found in the blood, without affecting their blood sugar, the researchers wrote. Those on Seroquel also had an increase in total cholesterol and triglycerides, and patients on Abilify didn’t have any significant worsening in their blood fats or blood sugars, according to the scientists.

Correll recommended that parents monitor their children’s weight and make sure the kids are eating healthy food and exercising.

Doctors in some cases should consider counseling and behavior therapy, as well as parental training, before prescribing the drugs, Correll said. Once the medicines are given to children and adolescents, doctors need to frequently monitor the weight gain and the patients’ blood sugars and blood fats, he said.

In the editorial accompanying the study, Varley wrote, “Given the risk for weight gain and long-term risk for cardiovascular and metabolic problems, the widespread and increasing use of atypical antipsychotic medications in children and adolescents should be reconsidered.”

The study was funded partly by the U.S. National Institutes of Health, based in Bethesda, Maryland.

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