August 22, 2007
Risperdal Approved by FDA for Treatment of Bipolar Disorder In Children and Teens
A few months ago we featured a news story that Risperdal was in the process of being approved by the FDA for use in children and adolescents for treatment of Bipolar Disorder. Many psychiatrists already prescribe the drug to children and teens, but now the FDA has approved its safety and use based on further research.
Now that its officially approved, the research that lead to the approval may have strengthened the efficacy and safety of Risperdal's use in children and teens. Until now, physicians have not had a lot of guidance in prescribing the drug to these younger populations.
Doctors have, in many cases, been using Risperdal and other antipsychotic medicines to treat bipolar disorder, but the drug agency’s stamp of approval will allow Johnson & Johnson to promote the drug for short-term treatment of bipolar episodes in ages 10 to 17.
"The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population," said Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics. "These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients."
However, The Wall Street Journal reported today that there are still many concerns about the long term impact of giving medications to children:
"Some doctors are concerned about the safety of treating children whose bodies are still growing with Risperdal and similar medications. They point out that the FDA's decision is based on short-term studies. Risperdal and competing drugs have previously been tied to serious side effects including increased blood sugar, a potential precursor to diabetes.
"We definitely need to have longer-term followup data to learn the full extent of the side-effect liabilities," said Jeffrey Lieberman, chairman of the psychiatry department at Columbia University in New York. His department gets research funding from drug companies."
There are still side effects and dangers associated with its use - as has been known with adult use. "Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported."
To reduce the risk of side effects patients on Risperdal should have their diet and weight gain closely monitored and have their dosage or medication adjusted if needed.
Risperdal is manufactured by Janssen, L.P. of Titusville, N.J
Read Full FDA Press Release:
FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents
Posted by Michelle Roberts at August 22, 2007 10:47 AM
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Bipolar Disorder Medications
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Bloomberg News reported, "In trials, 27 percent of those receiving the highest dosage of Risperdal had symptoms of neurological side effects that cause involuntary jerking or movements, compared with 5 percent of patients on placebos."
According to Risperdal's FDA package insert, in two 8-week clinical trials of pediatric patients 46% of the kids on Risperdal suffered movement disorders including tremor, dystonia, automatism (tics), dyskenisia or parkinsonism, vs. 8% on placebo. That's a 475% greater risk for movement disorders in children on Risperdal!
The pediatric trial results are copied below.
http://www.fda.gov/MedWatch/safety/2006/Oct_PIs/RisperdalTabs_PI.pdf
RISPERDAL (risperidone)
Incidence of Treatment-Emergent Adverse Events in Two 8-Week, Placebo-Controlled Trials in Pediatric Patients with Autistic Disorder
Adverse Event RISPERDAL Placebo
Somnolence 67% 23%
Appetite increased 49% 19%
Confusion 5% 0%
Saliva increased 22% 6%
Constipation 21% 8%
Dry mouth 13% 6%
Fatigue 42% 13%
Tremor 12% 1%
Dystonia 12% 6%
Dizziness 9% 3%
Automatism 7% 1%
Dyskinesia 7% 0%
Parkinsonism 8% 0%
Respiratory infection 34% 15%
Weight increase 5% 0%
Tachycardia 7% 0%
Ben Hansen
Traverse City, Michigan
Posted by: Ben Hansen at August 23, 2007 8:17 AM
This means that once they approved it for bipolar disorder, they approved it as a treatment for schizophrenia too, isn’t it so? But as far as I know, the limit age is not 10 as you say. It’s 13. I remember reading that on a flyer in a Canadian pharmacy. So… how is it, in the end?
Posted by: Ada at May 19, 2008 3:42 PM
Risperdal was a wonder drug for me, when I first started taking it as a teenager. That was, until I was diagnosed with dystonia, caused by risperdal. I couldn't walk, or sit up. I was forced to quit wrestling, stop working out, minimize my social life to such a low level, that hanging out with my friends was something I was not able to do for a long time. Before, I had been a very athletic and competitive teen. I had been working out consistantly for about 4 years prior to the onset of this dystonia. Being taken off the risperdal, I was put on a drug called artane (the dystonia drug with the least side effects). There is no cure for the dystonia, but the artane soon allowed me to walk (with a very weird posture). After upping the dose of the artane, I suffered a schizophrenic episode as a side effect, and was put on other meds to counter it. The symptoms that risperdal treats are very tolerable in comparison with the drug's side effects. No matter how large or small the percentage of people who develop side effects from risperdal, remember that these percentages are made up of people. Just think about how your life would be if you weren't able to walk? How many people want to see their children recieving their diploma on stage in a weelchair? You decide.
Posted by: Matt W. at August 18, 2008 7:15 PM
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Bloomberg News reported, "In trials, 27 percent of those receiving the highest dosage of Risperdal had symptoms of neurological side effects that cause involuntary jerking or movements, compared with 5 percent of patients on placebos."
According to Risperdal's FDA package insert, in two 8-week clinical trials of pediatric patients 46% of the kids on Risperdal suffered movement disorders including tremor, dystonia, automatism (tics), dyskenisia or parkinsonism, vs. 8% on placebo. That's a 475% greater risk for movement disorders in children on Risperdal!
The pediatric trial results are copied below.
http://www.fda.gov/MedWatch/safety/2006/Oct_PIs/RisperdalTabs_PI.pdf
RISPERDAL (risperidone)
Incidence of Treatment-Emergent Adverse Events in Two 8-Week, Placebo-Controlled Trials in Pediatric Patients with Autistic Disorder
Adverse Event RISPERDAL Placebo
Somnolence 67% 23%
Appetite increased 49% 19%
Confusion 5% 0%
Saliva increased 22% 6%
Constipation 21% 8%
Dry mouth 13% 6%
Fatigue 42% 13%
Tremor 12% 1%
Dystonia 12% 6%
Dizziness 9% 3%
Automatism 7% 1%
Dyskinesia 7% 0%
Parkinsonism 8% 0%
Respiratory infection 34% 15%
Weight increase 5% 0%
Tachycardia 7% 0%
Ben Hansen
Traverse City, Michigan
Posted by: Ben Hansen at August 23, 2007 8:17 AM
This means that once they approved it for bipolar disorder, they approved it as a treatment for schizophrenia too, isn’t it so? But as far as I know, the limit age is not 10 as you say. It’s 13. I remember reading that on a flyer in a Canadian pharmacy. So… how is it, in the end?
Posted by: Ada at May 19, 2008 3:42 PM
Risperdal was a wonder drug for me, when I first started taking it as a teenager. That was, until I was diagnosed with dystonia, caused by risperdal. I couldn't walk, or sit up. I was forced to quit wrestling, stop working out, minimize my social life to such a low level, that hanging out with my friends was something I was not able to do for a long time. Before, I had been a very athletic and competitive teen. I had been working out consistantly for about 4 years prior to the onset of this dystonia. Being taken off the risperdal, I was put on a drug called artane (the dystonia drug with the least side effects). There is no cure for the dystonia, but the artane soon allowed me to walk (with a very weird posture). After upping the dose of the artane, I suffered a schizophrenic episode as a side effect, and was put on other meds to counter it. The symptoms that risperdal treats are very tolerable in comparison with the drug's side effects. No matter how large or small the percentage of people who develop side effects from risperdal, remember that these percentages are made up of people. Just think about how your life would be if you weren't able to walk? How many people want to see their children recieving their diploma on stage in a weelchair? You decide.
Posted by: Matt W. at August 18, 2008 7:15 PM