Natalia
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 Posted: 08/24/07 - 01:40 Post subject: Antipsychotic Risperdal Approved by FDA for Use in Some Chil |
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FDA has approved the atypical antipsychotic Risperdal for use in children suffering from schizophrenia and bipolar disorder. Previously, Risperdal, manufactured by Johnson & Johnson subsidiary Janssen, has been approved Risperdal for use in adults with schizophrenia and bipolar disorder and for use children ages five to 16 with irritability associated with autism.
The expanded approval includes children ages 13 to 17 with schizophrenia and short-term use in children ages 10 to 17 with bipolar disorder. FDA statistics say that between 0.1% to 1% of reported schizophrenia cases involve children ages 13 to 17.
This approval will lead to physicians prescribing Risperdal over rival medications that have not received FDA approval for those uses and to health insurers covering for it.
The expanded approval for Risperdal is based on three clinical trials that were conducted by tha manufacturer. The trials involved around 600 children. After the studies around 8% of participants experienced weight gain of about four kilograms but that ended after three or four months. Over half of trial participants experienced an increase in prolactin, a lactation hormone and 1.5% developed breast milk. Other side effects that occurred in patients during the trials were drowsiness, fatigue, increased appetite, anxiety, nausea, dizziness, dry mouth, tremor and rash.
The trials conducted were short-termed and lasted only three, six and eight weeks. Longer-terms trials are needed as well and planned by the manufacturer in the future.
Many health experts feel that antipsychotic drugs are already been over-prescribed largely due to marketing campaigns conducted by pharmaceutical companies.
The incidence of such drugs being prescribed to patients ages 20 and younger increased from about 201,000 in 1993 to 1.2 million in 2002. Concerns have been raised over the safety of the drugs and influence on the still not developed bodies of these patients.
However, FDA obviously feels that potential benefits of Risperdal and other atypical antipsychotics in children with schizophrenia and bipolar disorder outweigh the risks. |
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