The studies cited by the FDA in approving Risperdal for schizophrenia and bipolar disorder in children are discussed in this FDA report:

www.fda.gov/cder/foi/esum/2007/020272s046s047,020588s006s037,021444s020s021_risperidone_clinical_BPCA.pdf

The FDA tells us the safety for schizophrenia was based on 3 studies. One was placebo-controlled (6 weeks), one low-dose controlled (8 weeks), and one open-label (6 months).

The safety for bipolar disorder was also based on 3 studies.  One was placebo-controlled (3 weeks), one was the same "long-term" open-label study mentioned above (6 months), and one was a "pharmacokinetic" study (length of study not mentioned).


WHY DID THE FDA OMIT THE LENGTH OF THIS STUDY?  THE ANSWER CAN BE FOUND IN ANOTHER FDA DOCUMENT:

http://www.fda.gov/cder/foi/esum/2007/020272s046_risperidone_clinpharm_BPCA.pdf

"The population pharmacokinetic study was done in 472 children and adolescents patients, ages 6-18. Study durations were from 12-21 days."


THERE YOU HAVE IT:

AS LITTLE AS 12 DAYS!  3 WEEKS AT THE MOST!


This allows the FDA to declare with a straight face:

"There were no reports of tardive dyskinesia in the pediatric study populations."


If you want to see the real-world incidence of tardive dyskinesia caused by Risperal in children, you won't find it ANYWHERE on the FDA web site.  But you will find a glimpse here:

http://www.psychdrugdangers.com/risperdal.html


For a real-world look at Risperdal prescribing patterns in a state Medicaid program, go here:

http://www.psychdrugdangers.com/psychotropicages0-18.html

The above web page lists all 7,327 New Jersey Medicaid Risperdal prescriptions for children under age 18 written in 2006.  The Risperdal prescriptions are sorted by age and dosage.

Note the number of children on Risperdal rises steadily until ages 11 or 12, then the numbers begin to decline.  This is NOT because the number of children on antipsychotics begins to decline.  Risperdal is the GATEWAY antipsychotic, but after a year or two the kids are often switched to a different antipsychotic (usually Seroquel or Abilify first, then Zyprexa or Geodon, and/or back to Risperdal later).
Meanwhile all sorts of other psychiatric drugs are thrown into the mix, and before you know it these kids are REALLY sick... thanks to the wonders of modern medicine, and thanks to all the doctors who write all the prescriptions, and thanks to all the taxpayers who foot the bill.


In October 2006 the FDA approved Risperdal for autistic irritability in children, based on two 8-week trials of 76 kids on Risperdal and 80 kids on placebo, detailed here:

http://www.fda.gov/MedWatch/safety/2006/Oct_PIs/RisperdalTabs_PI.pdf


Adverse Reaction     Risperdal        Placebo
Tremor                       12%              1%
Dystonia                     12%              6%
Automatism (tics)         7%              1%
Dyskinesia                    7%              0%
Parkinsonism                8%              0%


Reviewing these trial results, I have a question:

How is it that 6% of the kids on placebo develop dystonia, while only 1% develop tremor?  Can anyone out there offer possible explanations???


One more thing:

The average dose in the Risperdal autism trials was under 2mg/day.  The FDA approved Risperdal for kids over age 5, 0.5 mg/day for 15-20 kg body weight, and 1mg/day for those over 20 kg.  Look again at the New Jersey Medicaid prescriptions for Risperdal, and count the number of 2mg, 3mg and 4mg scrips.  Not to mention all the kids under age 5 on doses ranging from 0.25mg to 3mg.

When the FDA approves a psychiatric drug at a certain dose for a certain age, history shows that doctors often ignore the FDA guidelines.

On the subject of Risperdal's pediatric dosage, the author of the FDA report had this to say:


"While I believe we should certainly label the drug with the information learned from the clinical trials, and even identify target doses of 3 mg/day for pediatric schizophrenia and 2.5 mg/day for pediatric bipolar I disorder, I think it would be too restrictive to the prescriber to limit the dose to a maximum when we know that doses up to 6 mg/day were also shown to be efficacious in the same studies that demonstrated efficacy for the lower dose ranges."


Yes, that's what FDA Deputy Director, Dr. Mitchell V. Mathis really said.  You can read his full report here:
www.fda.gov/cder/foi/esum/2007/020272s046s047,020588s006s037,021444s020s021_risperidone_clinical_BPCA.pdf


Ben Hansen
Traverse City, Michigan

Institute for Nearly Genuine Research
www.bonkersinstitute.org