FDA Approves Abilify for Treatment of Schizophrenia in Teens
(November 7, 2007) The U.S. Food and Drug Administration has approved the
Bristol-Myers Squibb
antipsychotic drug
Abilify (aripiprazole) for
adolescents aged 13 to 17 diagnosed with schizophrenia. It's only the second
drug specifically approved to
treat schizophrenia in teens. Last August, the
FDA approved
Risperdal for the treatment of
schizophrenia in adolescents
aged 13-17.
The FDA first approved the drug to treat schizophrenia in adults in
November 2002. More than 12.5 million U.S. prescriptions for the medication
have since been written, the drug maker said.
Expanded approval to teens was based on a six-week, 13-nation study that
"demonstrated significant improvement with Abilify compared to placebo," a
company statement said.
Side effects seen in the study included extrapyramidal disorder (physical
symptoms such as involuntary muscle movements, abnormal posture, and slurred
speech), sleepiness, and tremor. These side effects were more common in
teens taking higher doses of the drug.
Weight gain of more than 7% was seen in some 5% of patients on Abilify
compared with 1% on a sugar pill. But that's mild compared with Eli Lilly's
Zyprexa, which tends to double the weight gain seen in adults when used in
kids. As a result, the FDA asked Lilly for more information about the
medicine's use in adolescents, delaying approval for that population.
Abilify also is approved to treat acute
manic or
mixed episodes in people
with
bipolar I disorder.
Source: HealthDay News
Last updated: 11/07
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