A recent study suggests risperidone, the generic drug also sold under the brand name Risperdal, could be useful as an ADHD drug for children.

The study was published online in the Journal of Child and Adolescent Psychopharmacology.

The research suggests that a therapeutic strategy that includes risperidone and parental training could be beneficial for children with ADHD who exhibit severe aggression.

Researchers studied the effects of risperidone on two groups of children ages 6 to 12 who had been diagnosed with ADHD and disruptive behavior disorder and who had exhibited severe physical aggression.

Both groups were treated with stimulant medication and parental training in behavioral management techniques.

One group had risperidone added to their regimen, and the other group was given a placebo. The childrens’ teachers reported that the group taking risperidone showed a decline in anxiety symptoms compared to the group that didn’t receive the same drug.

Risperdal’s Future as an ADHD Drug for Children

Risperidone has been on the U.S. market since it was first approved by the FDA in 1993 as a treatment for schizophrenia. It’s now also approved to treat manic or mixed episodes associated with bipolar disorder, as well as behavioral problems associated with autism spectrum disorders.

Under the brand name Risperdal, the drug has been a significant business success for manufacturer Johnson & Johnson. At its peak, annual sales had exceeded $4.5 billion.

Even since J&J lost patent protection and had to compete with generic versions, Risperdal still brings in hundreds of millions of dollars in sales revenues every year.

While Risperdal is not yet FDA-approved as an ADHD drug for children, some doctors have already begun prescribing it for that use. Doctors are legally allowed to prescribe medications for these so-called “off-label” drug uses on a case-by-case basis.

By one measure, more than 3.5 million children are now treating ADHD symptoms with Risperdal.

Should Risperdal develop a new reputation as an ADHD drug for children, it will introduce a new set of patients to the risks of Risperdal side effects. Perhaps most notoriously, the drug has been linked to abnormal breast development in boys, known clinically as gynecomastia.

Scientists believe the way that Risperdal manipulates the brain’s use of neurotransmitters may be what causes male patients to develop breast tissue. It can lead to an excess of prolactin, a hormone that normally stimulates the production of milk in pregnant women.

Male patients can experience the same breast effects if their naturally lower levels of prolactin are artificially increased.

While gynecomastia may resolve by itself after the patient stops taking Risperdal, sometimes the condition persists. The most stubborn cases may require male breast reduction surgery.

The physical deformity and psychological fallout that comes with gynecomastia has led large numbers of affected patients to file product liability lawsuits against J&J.

The company has already paid hefty penalties in settlements with state and federal enforcement agencies, in part over allegations that it improperly marketed Risperdal for use in child patients without FDA approval.

J&J began settling the current civil claims in 2012. More civil litigation could be in the company’s future as word gets out about Risperdal’s possible side effects.