Amid increasing reports of safety issues regarding antipsychotic medications in adults (particularly in the elderly), are reports that children are receiving antipsychotic medications at alarming frequency.
Clinicians often prescribe the medications "off label" for conditions the FDA has not approved them to treat, but an FDA advisory committee now says the agency needs to step up to control such prescribing. Physicians are at liberty to prescribe medications off-label once the FDA approves a medication for any condition.
The New York Times cites this example: more than 389,000 children received Risperdal, Johnson & Johnson's antipsychotic drug. Clinicians often prescribed the drug to treat the spectrum of attention deficit disorders, although the medication is not indicated for such use. Of these children, nearly a quarter-million were 12 or younger. Risperdal's side effects can be serious and permanent. These include permanent muscle problems such as tardive dyskinesia and dystonia, which the advisory panel said makes it not worth prescribing for many children. Other drugs of concern included Abilify, Geodon, Seroquel and Zyprexa.
Between 1993 and 2008, 1,207 children have suffered serious problems after taking Risperdal, and 31 of them has died. Of the 31 children who died, about one-third were taking the medication for unapproved uses.
The advisory committee met with federal regulators on Tuesday to discuss antipsychotic use among children. The intent of the meeting was a routine review of the safety of Risperdal and Eli Lilly's Zyprexa and the FDA hoped the committee would endorse the agency's safety efforts.
Instead, the committee rejected the FDA's safety proposals and expressed frustration with the FDA's reaction to the increased prescribing. The agency responded that there wasn't much it could do besides what it had already done (warnings on the labels), and that the responsibility for over-prescribing should fall on the shoulders of specialty medical societies.
- read the New York Times story
- see the Pharmalot blog post