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Bristol-Myers Abilify Antipsychotic Approved For Autism Irritability

Posted by Jane Akre
Monday, November 23, 2009 11:58 AM EST
Category: Protecting Your Family
Tags: Atypical Antipsychotics, Autism, Abilify, BristolMyers Squibb, Seroquel, Zyprexa, FDA

Abilify not approved for use in children, adolescents and teens with autism irritability.

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IMAGE SOURCE: © Wikimedia Commons / Abilify/ author: Boboque 


Abilify for Autism

Bristol-Myers Squibb Co. (BMS) got some good news this weekend when the Food and Drug Administration (FDA) approved its top-selling Abilify to treat children for autism-related irritability.

BMS and Otsuka Pharmaceutical Co. of Tokyo are collaborators in both the development and distribution of Abilify in the U.S. and Europe, reports Business Week.

Abilify is given to children, ages six through 17 to treat aggression toward others, self-injury, moodiness and temper tantrums associated with autism. The companies say the drug should be used as part of a comprehensive treatment plan including psychological counseling, education and socialization.

An article in the December 2009 Journal of the American Academy of Child and Adolescent Psychiatry says any medication should be accompanied by a structured training program for parents to reduce serious behavioral problems in autistic children.

Abilify is a blockbuster for BMS. As its second largest revenue generator, it produced $2.2 billion in sales in 2008.

Abilify now joins a crowded field of medications for brain disorders.

ScheringPlough Corp.’s Saphris treats schizophrenia and bipolar disorder. Pfizer’s Geodon, J & J’s Risperdal, Astra Zeneca’s Seroquel and Eli Lilly’s Zyprexa have combined sales of over $15 billion a year.

A study published in the October 28 Journal of the American Medical Association, finds that so called-second generation antipsychotic medications have not been sufficiently studied in pediatric and adolescent patients and that first-time users experience an increase in bad cholesterol levels and a weight gain that is alarming.

Included were Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), or Abilify (aripiprazole). After 11 weeks, the patients had gained anywhere from 10 to 19 pounds on average. Zyprexa takers gained the most on average and Abilify users the least.

Additionally the Zyprexa patients showed higher LDL cholesterol and triglyceride levels, indicating more fat in the blood. Seroquel patients had higher triglycerides.

The degree of weight gain is alarming,” said Dr. Wayne K. Goodman, head of a Food and Drug Administration advisory panel on the drugs last summer and chairman of psychiatry at Mount Sinai School of Medicine in Manhattan. “The magnitude is stunning,” he said to the New York Times.

The young patients seem to lose the weight when they come off the drugs. The theory is that the drugs may block the signal of satiety.

Last year Canadian researchers found that elderly patients who are given antipsychotic drugs are three times as likely to experience serious health problems or death within a month of use, compared to those patients not given the drugs. #


1 Comment

Anonymous User
Posted by Simone Oliveira
Thursday, January 07, 2010 12:01 PM EST

My son was hurting himself and very aggressive towards everybody. He has been on Abilify for over a month, but I could see the results in less than a week. I call Abilify the MIRACLE drug.

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