Just when the FDA advisory panel wants to address antipsychotics in kids: ABILIFY label revision for kids as young as 6 years old arrives

I'm not so sure that the FDA advisory panel understands metabolic syndrome or permanent movement disorders such as lip smacking (uncontrollable)or body twitching, tremors, shuffling gait, the weight gain that is caused by metabolic changes by an antipsychotic isn't your typical childhood obesity (if there is one)due to eating chips and drinking sodas in front of X Box all afternoon, this is serious stuff.

On the heels of this so-called concern for kids on antipsychotics, the FDA has already approved the antipsychotic Abilify for use in kids age 10-17 and as young as 6 years old for autistic behavior control, and now comes a new label revision highlighting the side effects that cause concern. Why have they approved Abilify for kids when these risks were already there?



From Reuters

"The FDA in the next month to six weeks will release a revised label for Abilify, a drug sold by Bristol-Myers Squibb Co and Otsuka Pharmaceutical and approved to treat schizophrenia in adolescents, bipolar disorder in children 10 to 17 years old and irritability associated with autism in those as young as six.

"We ask that with this upcoming revision that you carefully consider the language around pediatric use and adverse events," said Dr. Geoffrey Rosenthal, the committee's chair and director of Pediatric and Congenital Heart Center at the University of Maryland Medical Center.

Abilify's new label will detail the drug's latest clinical trials, warn of metabolic concerns and remind doctors to monitor weight and symptoms of diabetes in all patients, said Dr. Thomas Laughren, FDA's psychiatry products chief. The pediatric section of the label would contain a reference to those warnings, he said..

Such revisions, which are already incorporated into Johnson & Johnson's antipsychotic medication Invega Sustenna, are being considered for other similar drugs on a case by case basis, Laughren said.

The new generation of antipsychotic medications has raised a wave of concerns as they are increasingly being prescribed for a host of uses and for younger and younger patients, with little conclusive research addressing their impact on children and sometimes with little evidence they work."