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• Pharma Blog » 2008 » November » 19
By Ed Silverman // November 19th, 2008 // 6:42 am
After a steady stream of reports that antipsychotics are increasingly prescribed to children, often for unapproved uses, such as treating attention deficit disorders (back story), an FDA advisory committee yesterday chastised the FDA for not doing more to discourage such prescribing.
For instance, more than 389,000 youngsters last year were given Johnson & Johnson’s Risperdal, and 240,000 were 12 or younger, The New York Times writes. Often, the drug was prescribed to treat attention deficit disorders, but Risperdal is not approved for that use and its risks – weight gain, metabolic disorders and possibly permanent muscular tics – aren’t justified, panel members said.
“This committee is frustrated,” Leon Dure, a pediatric neurologist from the University of Alabama School of Medicine and panel member, told the meeting. “And we need to find a way to accommodate this concern of ours.”
However, Tom Laughren, director of the FDA’s division of psychiatry products, told the panel that the agency could do little to fix the problem and, instead, pointed the finger at medical specialty societies, which he insisted must do a better job educating doctors about side effects.
The meeting started as a routine review of the pediatric safety of Risperdal and Lilly’s Zyprexa, and the FDA proposed the committee endorse its safety monitoring and support previous efforts to highlight risks. But the panel unanimously rejected the proposals, saying far more needed to be done to discourage rising prescribing to children, particularly for unapproved uses, according to the Times.
“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,” Daniel Notterman, a senior health policy analyst at Princeton University and a panel member, told the meeting.
FDA officials responded that they already placed strong warnings on labels. “I’m a little puzzled about the statement that the label is inadequate,” Laughren told the panel. “I’m anxious to hear what more we can do in the labeling.”
But panelists said the current warnings were not enough, and while they spoke at length about Risperdal, they said their concerns applied to the other medicines in its class, including Zyprexa, Seroquel, Abilify and Geodon, the Times writes.
Prescription rates for the drugs have increased more than fivefold for children in the past decade and a half, and doctors now use the drugs to settle outbursts and aggression in children with a wide variety of diagnoses, even though children are especially susceptible to side effects, the paper writes.
A consortium of state Medicaid directors is evaluating the use of the drugs in children on state Medicaid rolls to ensure that they are being properly prescribed (back story). The growing use of the medicines has been driven partly by the sudden popularity of the diagnosis of pediatric bipolar disorder.
The leading advocate for the bipolar diagnosis is Joseph Biederman, a child psychiatrist at Harvard University who is being investigaged by the US Senate Finance Committee for allegedly failing to report to the university at least $1.6 million in outside income from drugmakers that sell antipsychotics (back story).
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, the Times notes.
From 1993 through the first three months of 2008, 1,207 children given Risperdal suffered serious problems, including 31 who died, according to the Times. 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 FDA.
Panel members said they had for years been concerned about the effects of Risperdal and similar meds, but FDA officials said no studies had been done to test the drugs’ long-term safety. Dure told the meeting he was concerned that doctors often failed to recognize the movement disorders, including tardive dyskinesia and dystonia, that can result from using these medicines.