Wednesday, November 19, 2008

Use of Antipsychotics in Children Criticized

It's about time:

WASHINGTON — Powerful antipsychotic medicines are being used far too cavalierly in children, and federal drug regulators must do more to warn doctors of their substantial risks, a panel of federal drug experts said Tuesday.

More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular medicines known as atypical antipsychotics. Of those patients, 240,000 were 12 or younger, according to data presented to the committee. In many cases, the drug was prescribed to treat attention deficit disorders.

But Risperdal is not approved for attention deficit problems, and its risks — which include substantial weight gain, metabolic disorders and muscular tics that can be permanent — are too profound to justify its use in treating such disorders, panel members said.

“The 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,” Dr. Daniel Notterman, a senior health policy analyst at Princeton University and a panel member, said when speaking about Risperdal.
Of course, FDA officials who were blindsided by the retort (not to mention representatives from Big Pharma) clanked into motion and questioned the panel's observations.
Drug agency officials responded that they had already placed strongly worded warnings on the drugs’ labels.

“I’m a little puzzled about the statement that the label is inadequate,” said Dr. Thomas Laughren, director of the agency’s division of psychiatry products. “I’m anxious to hear what more we can do in the labeling.”

Kara Russell, a spokeswoman for Johnson & Johnson, said, “Adverse drug reactions associated with Risperdal use in approved indications are accurately reflected in the label.”
Yet 31 children have died over the past 15 years because of Risperdal, and more than 1,200 kids have suffered "serious problems" related to its use. That doesn't strike me as particularly "accurate" labeling if the point is to issue adverse reaction warnings.

Here's another thought: I wonder if advocates of these medicines, who feel anxiety over having their authority questioned by this panel, might not pop a few Risperdal in order to focus and respond?

No comments: