A new lawsuit has been filed in Missouri on behalf of foster care children who were allegedly prescribed Risperdal and other psychotropic drugs inappropriately. The child advocates behind the lawsuit want the state to implement systemic changes that would curtail overprescribing of the medications.
“The bottom line is young kids — still developing bodies and brains — are exposed to powerful psychotropic medications in what is in almost in all circumstances off-label prescriptions,” Sara Bartosz, deputy director of litigation strategy at Children’s Rights, recently told The Associated Press.
The lawsuit alleges that medications like Risperdal are often used as “chemical straight-jackets” when prescribed to foster kids with ADHD and other behavioral problems. In most cases, the U.S. Food & Drug Administration (FDA) has not cleared the drugs for these indications.
Among the children named in the lawsuit are two sisters, ages 2 and 3, who were prescribed Risperdal. The medication has never been approved for use in children under 5.
Risperdal is currently indicated 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. While Risperdal was introduced in the 1990s, its pediatric indications weren’t approved by the FDA until 2006.
On November 4, 2013, the U.S. Department of Justice announced that Johnson & Johnson and Janssen Pharmaceuticals had agreed to pay $2.5 million to resolve criminal and civil charges stemming from the marketing of Risperdal and other drugs. Among other things, federal prosecutors had alleged that the companies improperly marketed Risperdal for off-label pediatric indications and concealed the side effects associated with its use.
Johnson & Johnson and Janssen have been named defendants in more than 18,000 Risperdal lawsuits, including many that were filed on behalf of men and boys who allegedly developed gynecomastia due to its use. Among other things, these lawsuits claim that about 20% of Risperdal prescriptions were written for children, allegedly due to the defendants’ aggressive off-label marketing efforts.
Gynecomastia is a condition marked by the growth of female-like breasts in men and boys. According to Risperdal lawsuits, the drug can stimulate the pituitary gland to produce excess levels of a hormone called prolactin, which plays a role in female breast development. High levels in males can also result in excessive breast growth.
In 2006, the Risperdal label was updated to note that gynecomastia occurred in 2.3% of pediatric patients. Previously, gynecomastia was listed as a rare side effect that occurred in fewer than 1 in 1000 patients.