FDA Panel Slams Rising Antipsychotic Use In Kids
22 CommentsBy 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.
Dan A.
This should have been addressed a long time ago. It’s children.
Sam
Re Medicaid spending for these psychiatric drugs that are not FDA-approved for pediatric use: see http://www.psychdrugdangers.com/US/MedicaidPayments.html which tabulates the money we (as taxpayers) have been shelling out for these drugs to the tune of hundreds of millions of dollars. State Medicaid agencies should not have paid for and should not be continuing to pay for any psychiatric drug that is not FDA-approved for pediatric use and is not cited in a drug compendium. “Off label” prescribing is not a justification for Medicaid/Medicare reimbursement. It would be interesting to know how much of this increased drugging of pediatric patients is being funded by Medicaid/Medicare (i.e. U.S. taxpayers).
Lisa Van S
Dr. Laughren admits he’s a puzzled man!!… Hey Tom,… Children are dying from side effects and you appear to oblivious! I would be more than happy to purchase for you, a one way, first class ticket to China.
Inside the FDA
Medical societies cannot do a better job if Dr. Laughren actively works to prevent reviewers from doing their jobs. Retaliates and prevents communications of what we really know about the risks both outside of the FDA and even between reviewers.
It appears that Dr. Jenkin’s comments on cardiovascular toxicity of drugs may be in response to some of the information that has been discussed here in the Pharmalot comments. Yet talking about looking more preapproval in the future and doing more post marketing studies simply will not do anything. Look how we were repeatedly stonewalled on Vioxx and even the lack of adequate postmarketing pediatric exposure to detect long term toxicities with Zyprexa yesterday.
Also it was not only Zyprexa, linezolid was discussed yet even though we know drugs in this class cause bones to fuse during growth, we know a priori one year (post approval) pediatric data is unlikely to detect anything and thus we likely had false reassurances on both these drugs. Also look at lamictal yesterday. The basic science was there (i.e. published) to know that it would cause mental retardation and birth defects, and Glaxo actually brought the scientists in on sabbatical and published with them. Yet they intentionally promoted it to pregnant women and the information didn’t come out of the FDA until recently.
FDA has also worked with the USAN (United States Adopted Names) to change the naming conventions for these drugs (linezolid) so people in the future will not realize the connections. (Take a look at the atypical antipsychotics they’ve done the same thing there too.)
Sam as for Medicaid usage, Ed has reported on GAO reports requested by Sen. Grassley. Now you have to ask yourself, why did Sen. Grassley become interested in this in the first place.
Congress should ask FDA for information on where all reviewers who have worked on new drug applications of psychiatric and neurology drugs in the past 5 years are now. They should then speak to every single reviewer in these groups and in particular those who are no longer there.
Even if Dr. Laughren leaves FDA (he’s near retirement) be very afraid of the person he’s put in place to succeed him, and also those to succeed him.
Comments are personal opinion and do not necessarily reflect the position of the FDA.
Lisa Van S
My personal opinion is this…. If President-Elect Obama seriously wants change, then he should nominate Dr. David Graham to be FDA’s next Commisioner.
Sam
Inside the FDA:
That Pharmalot article on Sen Grassley’s investigation is where I first learned of the Center for Medicare & Medicaid Services data source from which I built the Medicaid tables.
As for Lamictal (lamotrigine), it’s a deadly drug when given to pregnant women. See http://www.psychdrugdangers.com/MothersAct.html and then Drug Tables > Mood Stabilizers > Lamotrigine. It was identified as the Primary Suspect Drug deemed responsible for 148 miscarriages (a.k.a. Spontaneous Abortions) in the MedWatch reports from 2004 through 2007 (and 17 new reports for 2008) with 2/3d’s of those reports being submitted by Doctors or Other Healthcare Professionals (i.e. not laypersons). That’s the highest Spontaneous Abortion count of all the drugs shown.
Ima Misfit
Ed,
You would have scooped the NYT on this story if you’d have used the data I gave you a couple of months ago.
The FDA is just now concerned about antipsychotic use in children?
They’ve known about this for many years. Janssen reps selling Risperdal began targeting Child Psychiatrists 8 years ago.
Lisa Van S
Sam,.. Is their any way of knowing which state reported the most miscarriages. New Jersey is the only State that mandates mental health screenings for pregnant women, these screenings are given to determine who is suffering from postpartum depression, I find this disturbing because PPD may rear its ugly head only after,.. not before,!! a woman gives birth.(questionaire given is similar to teenscreen)
Inside the FDA
Sam,
I’m aware of that, what I’m saying is when I look at the scientific literature I find evidence that Glaxo was aware of a signal as far back as 1993. Why do you think Glaxo instituted the pregnancy registry in the first place. In spite of this they intentionally went after an indication with a high representation of pregnant women in 2001. Plus it appears to me that they hid their concerns and the basis for it from FDA until 2004 when there were publications about the pregancy registry results.
Neil Manowitz, PhD,
If prescription data mining were outlawed, you would not have companies like IMS pointing the great big arrow to the offices of the pediatricians that prescribe psychotropic drugs to children that are only indicated for adults.
Robert
This article mainly addresses Risperdal, where there are a many other anti-psychotic drugs inluding Ritalin which are in far more wide. Many new laws are being put in place to not only fund these dangerous anti-psychiatric drugs but to force people to take them. These drugs are being prescribed by the same psychiatric organizations which previously performed lobotomies now outlawed and ECT (Electro-Convulsive-Therapy) which is still being practiced.
Steve
The article talks about anti-psychotics not being approved for use in children then mentions Risperdal. However, Risperdal does carry a pediatric indication. While the indication is not for ADHD. ADHD is highly comorbid with other psychiatric disorders. Therefore, it is possible that child with ADHD takes Risperdal, most likely in conjunction with other medications. The article leads one to believe that Risperdal is being used to treat ADHD without actually making that statement. I question the motivations of the author.
Salmon
Steve,
ADHD is highly comorbid with other disorders that occur later in life. 60% of the drug use here is in children less than 12. We cannot be certain of accurate diagnoses especially in this age group as the symptoms early on may not be easily distinguishable from ADHD. Plus why even use it in children when it isn’t even used for these indications in adults except that they’re more expensive ($400 - $500) / month AWP.
Margaret
ADHD is a crock, as is “pediatric bipolar”. Notice this “problem” in any other country.
Dr. Laughren should be one of those who should be fired immediately, with NO PENSION. Have you ever seen him at a public hearing, staring down at his knees? Hurry up, Obama.
It is beyond belief that these drugs do not have black box warnings. They do for seniors with dementia, a use which is not approved on label.
As for Zyprexa (son dead ) and Lamictal(daughter almost dead) where are the black box warnings for these for general use as well as pediatric use.? I guess the only hope is a new president who is not in bed with pharma; not controlling the FDA.
Lisa Van S
Steve,….Comorbid, ok, now lets see how this happens.
Small child has diagnosis of ADHD and is prescribed Ritalin, the child then suffers depression as a side effect, the child is then prescribed an antidepressant which causes the child to have suicidal thoughts and become manic or psychotic. In many cases the child suffers both. Then the Doc prescribes an antipsychotic and mood stabilizers. Comorbid diagnosis is the outcome of Polypharmacy!!!
Lisa Van S
Steve,.. One more thing, FDA never approved Risperdal for 6 month olds, so what kind of diagnosis could a Physician have to justify the prescribing of antipsychotics to babies.
Ima Misfit
Neil,
You make a good point. Big companies will aways find a way to get data. Rather than spending so much effort on getting rid of IMS data, States should be using this data to uncover fraud, drug diversion, and illegal prescription practices.
A few years ago, I reveiwed IMS data for a Dr. in PA, who was writing over 1,000 prescriptions for Oxcontin every month. Shortly thereafter he was arrested in some other state. He had a large amount of cash, numerous prescription pads, and a gun in his car. He was indicted and convicted, and is probably still in prison.
Sam
Lisa,
The MedWatch reports do not identify the State, only the Reporter Country (which is often not reported).
I am sure that there is an effort underway to redefine “postpartum depression” to mean “perinatal depression” (5 months before to 1 year after delivery). See http://www.womenshealth.gov/faq/depression-pregnancy.cfm (touting itself as “The Federal Government Source for Women’s Health Information”) which used to blatantly state only a few months ago: “Limited research suggests that many women with perinatal depression improve when treated with anti-depressant medicine. Your doctor can help you learn more about these options and decide which approach is best for you and your baby …”
But now has been revised to couch the apparent agenda in less overt terms:
“How common is depression during and after pregnancy?” … “Depression is a common problem during and after pregnancy.”
“How is depression treated?” … “Medicine. Your doctor can prescribe an antidepressant medicine. These medicines can help relieve symptoms of depression. If you are depressed, your depression can affect your baby. Getting treatment is important for you and your baby. Talk with your doctor about the benefits and risks of taking medicine to treat depression when you are pregnant or breastfeeding.”
The intra-uterine deaths, stillbirths, spontaneous abortions (miscarriages) and devastating birth defects that have been reported to the FDA on mothers taking a psychiatric drug during pregnancy would seem to make the practice foolhardy in the extreme, but that’s the agenda they appear to be pushing. And if the perinatal depression test is as “foolproof” as TeenScreen’s with its 84% false positive result, well …
Do you happen to have a copy of the test?
Sam
Inside the FDA:
What’s this “pregnancy registry” that you spoke of? Never heard of it.
Inside the FDA
Take a look at the original approval documents. I believe it’s there. If not it was instituted later and it’s somewhere in the Drugs@FDA website.
Lisa Van S
Sam,
No I dont have a copy of the test, I do plan of getting my hands on a copy. A young pregnant woman cited to me some of the questions that were on the so called screening test and it sure sounded quite similar to the infamous “Teenscreen”. Isnt it wonderful to know that our hard earned NJ taxpayer dollars are going to a program that could possibly have an 84% failure rate!!
The NJ Starledger reported today that 1 in 11 NJ residents goes to bed hungry, but yet we can spend 76 million dollars to drug infants and toddlers before they go to bed!!
Sam
Inside the FDA:
Thanks, I found the list of pregnancy registries:
http://www.fda.gov/womens/registries/registries.html
I find it interesting that only Lamictal (lamotrigine) and Wellbutrin, Wellbutrin SR and Zyban (bupropion) are in there for psychiatric drugs. Both are GSK products. Missing is Paxil (paroxetine).