Risperdal OK for kids with schizophrenia & bipolar

Sara PA

New Member
"The FDA has approved Risperdal for treating schizophrenia in adolescents 13 to 17 and for the short-term [three-week] treatment of bipolar I disorder in children and adolescents 10 to 17," Dr. Thomas Laughren, director of the Division of Psychiatry Products at the agency's Center for Drug Evaluation and Research, said during a midday teleconference.

I am a bit confused by this, however:

The agency first approved Risperdal (risperidone) in 1993 for treating schizophrenia in adults. It was approved subsequently for the short-term treatment of acute manic or mixed episodes of bipolar I disorder in adults and the treatment of irritability associated autism in children and adolescents aged 5 to 16, Laughren noted.

There is nothing in the prescribing information that mentions the treatement of aggression in autism and, as of tonight, the prescribing information still says:

Pediatric Use
Safety and effectiveness in children have not been established.

Nor do I remember reading about the approval for autism in children when it was approved for short-term treatment of acute manic or mixed episodes of bipolar I disorder in adults.

Sara PA

New Member
Ok, here it is. It was approved to treat children with autism in October, 2006. I was preoccupied with something the beginning of last October. (It was approved for the treatment of bipolar in adults in December, 2003.)


The U.S. Food and Drug Administration (FDA) today approved a new use of one of the leading prescription antipsychotic medications, RISPERDAL(R) (risperidone), for the treatment of irritability associated with autistic disorder, including symptoms of aggression, deliberate self-injury, temper tantrums, and quickly changing moods, in children and adolescents aged 5 to 16 years.(1) This is the first time the FDA has approved any medication for use in children and adolescents with autism.


New Member

Approved only two days ago, but interesting Dylan first tried this medication in 2002. He would have been only 6 years old.

I know of alot of people that have had alot of success with this medication.

I have a feeling the others are short to follow.

Thanks for the info.


Active Member
Sara, the guidelines are often different in Australia. I've been looking at Aussie-only sites and found the following:
"RISPERDAL can be used to treat conduct and other disruptive behaviours such as aggression, impulsiveness and self-injury in children (over 5 years old), adolescents and adults who are intellectually disabled.

RISPERDAL can also be used to treat behavioural symptoms of autism in children and adolescents."
This info is from the APP Online Guide, information uploaded in November 2006.

I do know that the above statement has opened the door for doctors to prescribe it for use in autism. However, it cannot be prescribed under the PBS (Pharmaceutical Benefits Scheme) unless your doctor gets an authority which states that the patient has schizophrenia. Most of our commonly used, doctor-prescribed only medications in Australia are prescribed under PBS. This means they cost a maximum of about $25 (the maximum goes up each budget). Some of the more unusual medications, or often the newer ones, are not covered by PBS and so cost full retail.

So if we had agreed to having our child permanently labelled as schizophrenic, we could have got our risperdal for quarter the cost. But if it's not actually the diagnosis, and it's a label that will stay with him in the medical system, why label the kid?
The authority to prescribe under PBS is organised through our HIC (Health Insurance Commission) which connects each person's medical history and activity record, including prescriptions and especially authority prescriptions, to each person's Medicare number - this is like a Social Security number, only even more tightly scrutinised or regulated. In Australia you only ever have one Medicare number per person, and one tax file number per person. Those numbers are now bureaucratically connected and are increasingly checked on and traced. Apart from kids leaving home and therefore applying for their own unique number (as distinct from cover under the family's Medicare cover) you have the same number for life. Tax, or Medicare.

Medicare is state-based basic medical insurance, financed by a percentage levy of a person's taxable income. Basic medical, hospital (public) and some other related services are at least partly covered by Medicare. Private medical cover is individually optional and is generally not related to employment. However, there is an added tax levy for people on above-average incomes who do not take out extra private health cover.

Because in Australia we do our own testing, our regulatory body (TGA = FDA) tends to be later than the US to release certain medications for use in various indications. It has saved us from disasters like Thalidomide - our delay meant only a handful of cases and even most of those were from early, pre-release samples doled out like Minties by one particular obstetrician. It has also meant we have been one of the first countries to ban Prexige. It also means, though, that you guys get the benefit of new drugs years before we do. Occasionally we develop something new, like the HPV vaccine, and sometimes this means we get it first or at least early, but we're a relatively small population which means this sort of research is generally uneconomic, as a starting point here. All our best stuff generally gets flogged overseas first, especially to the US.

Our system may seem draconian but it's far harder for someone to abuse our system because Big Brother is definitely alive and well and sunning himself down under. There are occasional loopholes exposed which are just as quickly patched. For such a 'free country' we do have a lot of government controls which are totally absent in a lot of other countries. And the "she'll be right, mate" attitude allows this high level of control to continue.



New Member
Im glad it is approved but unfortunately my difficult child cant take it. She took it right before her 9th birthday and she started her period 2 days after her birthday. Dr said it was the risperdal and took her off of it and she hasnt bled since. When I was on it myself, it made me lactate. So it screws up our womanly horomones. I wish it didnt because she needs to be on a medication like that.


Active Member
OK, difficult child 1 DID get "manboobs", but it was just fat in his case. Thank goodness! And it did go away when he went off the risperdal. He's now as scrawny as ever. And no apparent problems with difficult child 3.

However, just as it is wrong to use anecdotal evidence such as testimonials to say something is really great, it is just as inaccurate to look at our case and say, "See? THEY were fine..." so don't just assume that because we came though with no apparent lasting problems, that others will have the same experience. Anyone whose child is taking this - please keep a close eye on your child and maybe talk to your doctor if you have any concerns.