A new study suggests that many children with ADHD are being prescribed Risperdal (risperidone) and other antipsychotic medications, despite the risks associated with these powerful medications. What’s more, researchers writing in the Canadian Journal of Psychiatry found that a significant percentage of these children lack a mental health diagnosis for which these drugs are indicated.
In the U.S., Risperdal is currently approved to treat adult and adolescent schizophrenia; bipolar disorder in adults and children ages 10-to-17; and irritability in children (5-to-16 years of age) with autistic disorder. The use of Risperdal and other antipsychotics to curb disruptive behavior in children with ADHD is considered off-label use, as the U.S. Food & Drug Administration (FDA) has not cleared any of these medications for this purpose.
This new research involved records of 10,000 children and young adults, ages 1 to 24, treated by family physicians in Ontario, Canada. The study team determined that 5.4% had been diagnosed with ADHD. Of this group, 70% were prescribed ADHD medications, including stimulants and atomoxetine. Nearly 12% were prescribed an antipsychotic, the most common being risperidone. Among 1 in 4 of the children treated with an antipsychotic, no psychiatric diagnosis was noted in the chart other than ADHD.
“We don’t know why these children and youth with ADHD are on antipsychotics, but there is a risk associated with early antipsychotic exposure, so we need to know more about why they are being used so that the benefits can be weighed against the risks,” the study’s senior investigator said in a news release
In November, Johnson & Johnson’s quarterly earnings report indicated that the company has been named a defendant in 15,400 Risperdal lawsuits involving the drug’s alleged link to gynecomastia (male breast development) and other serious side effects. Court documents show that many of these claims were filed on behalf of plaintiffs who were prescribed the medication as children to treat ADHD and other off-label indications.
More than 2,000 of these cases are now pending in a mass tort litigation underway in Pennsylvania’s Philadelphia Court of Common Pleas. Since early 2015, the proceeding has convened a number of trials involving Risperdal and gynecomastia. Plaintiffs have prevailed in four, with juries awarding damages ranging from $70 million to $500,000. Jurors declined damages in a fifth case, while a sixth lawsuit was dismissed mid-trial for lack of evidence. Just last month, Johnson & Johnson agreed to settle the Risperdal lawsuit selected for the litigation’s seventh trial.
Bernstein Liebhard LLP represents plaintiffs in Risperdal gynecomastia lawsuits. If you or a loved one experienced excessive and disfiguring male breast growth that may be linked to the use of Risperdal, please call (888) 995-5099 to learn if you qualify to file a similar claim.