FDA approves atypical antipsychotics for children

The US FDA has approved the use of three atypical antipsychotic drugs for the treatment of schizophrenia and bipolar mania in children and adolescents. Quetiapine (Seroquel), ziprasidone (Geodon), and olanzapine (Zyprexa), which are already approved for adult use, have been widely used off-label by clinicians treating paediatric patients and are already used by paediatric psychiatrists in Australia. Some members of the FDA panel that approved the drug expressed concern about the lack of safety information available on the drugs’ side-effects on the 10-14 age group. "There is… a concern about using [the drugs] in this population because children are growing and developing and viewed as being particularly vulnerable to [their] effects,” director of the division of psychiatry products at the FDA Dr Thomas Laughren said in an interview. However Associate Professor of Child Psychiatry at the University of Melbourne Alasdair Vance told Psychiatry Update that the issue of prescribing psychiatric medications in the US has become increasingly politicised. While some groups simply oppose the use of any psychiatric medications in children, others are worried about rapidly increasing diagnoses of illnesses such as juvenile bipolar disorder. “The construct of juvenile bipolar disorder has been broadened to the point that it’s a very common disorder - between one and three percent of school age children have been diagnosed with it - and then you’re looking at very large numbers of children that could be on this medication,” he said. He said that while it is important that the drugs are monitored very carefully when they are used in the “remarkably rare” cases of children or young adolescents who will benefit from them, it is also important not to overstate the health worries attached to the drugs. “There’s very little long-term safety data in paediatrics generally… and these drugs seem to be well-tolerated,” he said....