More than 389,000 children and teenagers were treated with Risperdal—an atypical antipsychotic—last year. And, 240,000 of them were 12 years old or younger, the November 18th New York Times reports. A panel of federal drug experts stated that medications like Risperdal are ” being used far too cavalierly in children” and that “federal drug regulators must do more to warn doctors of their substantial risks.”
Risperdal has been approved for treating irritability in autistic children. The New York Times notes that “in many cases, the drug was prescribed to treat attention deficit disorders,” for which it has not been approved for:
The meeting on Tuesday was scheduled to be a routine review of the pediatric safety of Risperdal and Zyprexa, popular antipsychotic medicines made, respectively, by Johnson & Johnson and Eli Lilly & Company. Food and Drug Administration officials proposed that the committee endorse the agencyâ€™s routine monitoring of the safety of the medicines in children and support its previous efforts to highlight the drugsâ€™ risks.
But committee members unanimously rejected the agencyâ€™s proposals, saying that far more needed to be done to discourage the medicinesâ€™ growing use in children, particularly to treat conditions for which the medicines have not been approved.
â€śThe data show there is a substantial amount of prescribing for attention deficit disorder, and I wonder if we have given enough weight to the adverse-event profile of the drug in light of this,â€ť Dr. Daniel Notterman, a senior health policy analyst at Princeton University and a panel member, said when speaking about Risperdal.
The side effects of Risperdal are serious and include substantial weight gain, metabolic disorders, tardive dyskinesia and dystonia.
My son’s among those 389,000 children, and among those 240,000 children aged 12 and younger, who are taking Risperdal. He’s been taking Risperdal since the spring of 2004, at a time when his self-injurious behavior—head-banging—-was severe and he was on the verge of being removed from a public school special education classroom to an out-of-district placement. This is a more detailed account of what Charlie’s experience on Risperdal has been. The most difficult side effect has been the substantial increase in his appetite and the resulting wet gain; we’ve sought to address this by watching Charlie’s diet (and minimizing junk food, in particular) and by making sure he gets a lot of exercise.
I really didn’t want to put Charlie on medication. And truly, it’s not the “answer” in and of itself for addressing aggressive or “problem behaviors.” Even as he wrote the first prescription for Risperdal for Charlie, our pediatric neurologist told us sternly that Charlie also had to have behavior therapy; that we had to keep his education in mind first.
Charlie was 7 1/2 when he started taking Risperdal — since then, mostly via this post, I’ve heard of younger and younger children being prescribed Risperdal. The federal panel’s concern seems very much justified. The New York Times notes a few more reasons why, including the rise of the diagnosis of bipolar disorder in children; however:
The leading advocate for the bipolar diagnosis is Dr. Joseph Biederman, a child psychiatrist at Harvard University whose work is under a cloud after a Congressional investigation revealed that he had failed to report to his university at least $1.4 million in outside income from the makers of antipsychotic medicines.
In the past year, Risperdal prescriptions to patients 17 and younger increased 10 percent, while prescriptions among adults declined 5 percent. Most of the pediatric prescriptions were written by psychiatrists.
From 1993 through the first three months of 2008, 1,207 children given Risperdal suffered serious problems, including 31 who died. Among the deaths was a 9-year-old with attention deficit problems who suffered a fatal stroke 12 days after starting therapy with Risperdal.
At least 11 of the deaths were children whose treatment with Risperdal was unapproved by the F.D.A. Once the agency approves a medicine for a particular condition, doctors are free to prescribe it for other problems.
Panel members said they had for years been concerned about the effects of Risperdal and similar medicines, but F.D.A. officials said no studies had been done to test the drugsâ€™ long-term safety.
No studies done to test the drugsâ€™ long-term safety: It’s a phrase that keeps ringing in my ears; in any parents’ ears. Charlie can’t tell us how he feels taking the medications so it’s up to us and Charlie’s teachers to watch and observe, to adjust and alter. And to know that, medications can help, but they’re just on part of the picture, and a part that needs to be kept under very careful scrutiny.