Last Tuesday, the FDA convened an expert panel for a routine review and approval of the agency’s monitoring practices for antipsychotic medications in children.
Apparently, panel members didn’t get the memo.
The experts unanimously rejected the FDA proposals and implored the agency to step up efforts to curb overutilization of the drugs for safety reasons.
The drugs in question are known as atypical antipsychotics. They include Risperdal, Zyprexa, Seroquel, Abilify and Geodon, although much of the meeting focused on Johnson & Johnson’s Risperdal.
Nearly 400,000 children and teens took Risperdal last year, 60% of which were 12 years old or younger. Many received the drug for attention deficit disorders, pediatric bipolar disorder and non-specific aggressive behavior or emotional outbursts. The drug is not approved for these purposes.
And side effects of Risperdal and other atypical antipsychotics are profound, including marked weight gain, metabolic abnormalities and tics that can become permanent. More than 1,200 children have suffered serious problems attributable to Risperdal, including 31 who died.
Prescriptions for atypical antipsychotics increased 500% in the last 15 years. Psychiatrists pen most of the pediatric prescriptions for these drugs.
But the FDA’s Dr. Thomas Laughgren said the agency had already affixed stern warnings to the drugs’ labels and there was little more it could do. Maybe the medical professional societies can do more to educate prescribers, he suggested.