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More Antipsychotics Approved for Pediatric Use

From Psychiatric News:

Days before a Food and Drug Administration (FDA) advisory committee reviewed the safety concerns about antipsychotic drug use in pediatric patients, two additional antipsychotics, quetiapine and olanzapine, were approved by the agency for treating youth with schizophrenia and those with bipolar I disorder.

With these additions, four second-generation antipsychotics (SGAs) have been approved by the FDA for use in patients under age 18: risperidone, aripiprazole, quetiapine, and olanzapine. Indications are for the acute treatment of schizophrenia and bipolar I manic or mixed episodes based on three- to six-week clinical trials in pediatric and adolescent patients. Risperidone and aripiprazole have also been approved by the FDA to treat irritability associated with autistic disorders.

Other SGAs, including ziprasidone and paliperidone, and recently approved iloperidone and asenapine, are not approved for pediatric use but are sometimes prescribed off-label for children and adolescents.

In the past decade, mounting research evidence has linked SGAs to significant weight gain, increased blood glucose and cholesterol levels, and endocrine abnormalities in adult and underage patients.
At a public meeting held last December 8, representatives from the National Institute of Child Health and Human Development Antipsychotics Safety Therapeutic Working Group told the FDA's Pediatric Advisory Committee that the lack of knowledge about these drugs in the pediatric population is worrisome. A number of published epidemiological studies suggest that children may experience more dramatic weight gain and worse metabolic effects on SGAs compared with adults, the working group reported. Most recently, a study in the October 28, 2009, Journal of the American Medical Association showed that first-time SGA use was associated with a large increase in cardiometabolic risks in patients aged 4 to 19. The study found that average weight gain in youth taking SGAs ranged from 4.4 kg (aripiprazole) to 8.5 kg (olanzapine) after a median of 10.8 weeks.

The working group urged the FDA and National Institutes of Health to fund and conduct postmarketing studies, both retrospective and prospective, to clarify the long-term effectiveness and safety of SGAs in children and adolescents.

FDA OKs Abilify for autism-linked irritability

From BusinessWeek:

The U.S. Food and Drug Administration has approved top-selling Abilify as a treatment for autism-related irritability in children from the ages of 6 to 17, drug maker Bristol-Myers Squibb Co. said Friday.

Abilify is Bristol-Myers' second-biggest revenue generator, with $2.2 billion in 2008 sales.

The FDA's latest approval allows the drug to be used to treat symptoms associated with autism such as aggression toward others, deliberate infliction of self-injury, tempter tantrums and moodiness.

The companies said in a statement that it was intended to be used as part of a more comprehensive treatment program that includes educational, psychological and social aspects.

Several other drug companies sell medications that compete with Abilify for customers. One is Schering-Plough Corp.'s Saphris, used to treat schizophrenia and bipolar disorder. Others include Pfizer Inc.'s Geodon, Johnson & Johnson's Risperdal, AstraZeneca PLC's Seroquel and Eli Lilly & Co.'s Zyprexa. The drugs have combined sales of well over $15 billion a year.

Posted: 11/23/2009 1:52:00 PM

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Big Weight Gain For Kids on Psych Drugs

From TIME:

Children on widely used psychiatric drugs can quickly gain an alarming amount of weight; many pack on nearly 20 pounds and become obese within just 11 weeks, a study found.

Weight gain is a known possible side effect of the anti-psychotic drugs which are prescribed for bipolar disorder and schizophrenia, but also increasingly for autism, attention deficit disorders and other behavior problems. The new study in mostly older children and teens suggests they may be more vulnerable to weight gain than adults.

The study also linked some of these drugs with worrisome increases in blood fats including cholesterol, also seen in adults. Researchers tie these changes to weight gain and worry that both may make children more prone to heart problems in adulthood.

The study authors said their results show that children on the drugs should be closely monitored for weight gain and other side effects, and that when possible, other medicines should be tried first.

The study appears in Wednesday's Journal of the American Medical Association. It involved 205 New York City-area children from 4 to 19 years old who had recently been prescribed one of the drugs; the average age was 14.

Depending on which of four study drugs children used, they gained between about 10 and 20 pounds on average in almost 11 weeks; from 10 percent to 36 percent became obese.

The drugs are Abilify, Risperdal, Seroquel and Zyprexa. Of the four, Seroquel and Zyprexa are not yet approved for children, and they had the worst effects on weight and cholesterol. However, a government advisory panel recently voted in favor of pediatric use for the two drugs, and the Food and Drug Administration often follows its advisers' recommendations.

The drugs' makers said these problems are known side effects but emphasized the drugs' benefits in helping patients cope with serious mental illness.

The four drugs have been considered safer than older anti-psychotic drugs, which can cause sometimes permanent involuntary muscle twitches and tics. That has contributed to widespread use of the newer drugs, including for less severe behavior problems, a JAMA editorial said.

The number of children using these drugs has soared to more than 2 million annually, according to one estimate.

Why these drugs cause weight gain is uncertain but there's some evidence that they increase appetite and they may affect how the body metabolizes sugar, said Jeff Bishop, a psychiatric pharmacist at the University of Illinois at Chicago. The drugs also can have a sedation effect that can make users less active.