The claims made in hundreds of Risperdal lawsuit filings stand in stark contrast to a new study that suggests the drug could be an appropriate treatment for children who suffer from severe behavioral problems associated with ADHD. While legal claims involving the drug include allegations that its use caused gynecomastia and other serious side effects in children, the study suggests that adding Risperdal could curb violent or aggressive behaviors in those with ADHD.
Right now, Risperdal’s pediatric uses are limited to the treatment of bipolar disorder in children ages 10 to 17, schizophrenia in adolescents, and irritability in children (5-to-16 years of age) with autistic disorder. However, some data does suggest that off-label use of the drug to treat problems associated with ADHD is on the rise.
This new study, which appeared in the Journal of the American Academy of Child and Adolescent Psychiatry, involved 168 children between the ages of 6 and 12 who had been diagnosed with ADHD and oppositional-defiant disorder or conduct disorder, and who had experienced recent episodes of serious physical aggression. All of the children were initially treated with a stimulant medication, which is the standard with ADHD. Their parents also received specialized training to help them deal with impulsive behaviors.
At three weeks, those kids who showed no improvement were started on a second medication. Roughly half of that group (61) received Risperdal, while the remaining 69 received a placebo. By nine weeks, those receiving Risperdal saw “modest but significant improvements” in their behavior compared to children who only received Risperdal, according to the study
While the authors of the study conceded that it wasn’t a “grand slam,” they concluded that there might be justification for using Risperdal off-for the treatment of ADHD. However, they did advise physicians to proceed with caution, due to the risk of Risperdal side effects.
The publication of this study followed an investigation by Consumer Reports that found that more and more children are taking Risperdal and similar drugs for off-label uses. Among other things, the report raised concerns about the potential for serious side effects associated with this class of medications.
It should also be noted that hundreds of Risperdal lawsuits have been filed on behalf of individuals who allegedly suffered serious injuries due to their use of the drug. Many of these claims include allegations that the medication was illegally promoted for off-label uses in children. Several dozen claim that boys treated with the medication developed Risperdal gynecomastia, or male breast growth.
Off-label promotion of the drug was also addressed in a settlement Johnson &Johnson reached in November with the U.S. Justice Department. Under the terms of the settlement, the company agreed to pay $2.2 billion to resolve charges that it improperly marketed Risperdal and other drugs for off-label use. Among other things, the government had charged that the company promoted Risperdal for use in children before it was cleared for such purposes in 2006. The Justice Department had also alleged that Johnson & Johnson concealed side effects associated with the drug, including Risperdal male breast growth.
Victims of Risperdal male breast growth may be entitled to compensation for emotional distress, pain and suffering, lost wages, medical bills, and other injury-related damages. To learn more about filing a Risperdal lawsuit, please contact Bernstein Liebhard LLP by calling our office at .