Even as Risperdal’s manufacturers continue to face legal action over both their marketing practices and the alleged risk of gynecomastia, or “man boobs,” a new study suggests that the drug may be part of a helpful treatment for attention deficit hyperactivity disorder (ADHD).

The makers of Risperdal have come under fire for the practice of off-label marketing. This term has to do with the way drugs are approved in the United States. Under the law, a drug maker must thoroughly test a drug for both safety and efficacy, according to U.S. Food and Drug Administration (FDA) protocols. A drug maker must separately test a drug for efficacy against every condition they plan on marketing the drug for.

However, sometimes medical research outpaces the FDA approval process. Under these circumstances, a physician may legally use a drug for purposes other than the FDA-approved one. This is called “off-label” usage. However, the drug’s manufacturers are strictly forbidden from marketing a drug for off-label usage.

The FDA initially approved Risperdal for treating schizophrenia. However, the drug’s makers were able to get FDA approval for Risperdal to treat bipolar disorder and aggression/irritability associated with autism. However, Risperdal lawsuits and government investigators, have alleged that the drug’s makers have illegally promoted the drug for off-label usage, including using the drug for ADHD and senile dementia. In the case of dementia, studies eventually found that elderly dementia patients taking Risperdal had a greater risk of death, highlighting the potential danger of off-label usage.

In addition to marketing concerns — which have already resulted in fines for Risperdal manufacturer Janssen Pharmaceuticals — the company is currently facing hundreds of Risperdal lawsuits over a condition called gynecomastia or “man boobs.” It is alleged that Rispderdal complications can cause male patients, particularly adolescents, teenagers, and young adults, to grow female-like breasts due to increased prolactin levels promoted by the drug. Concerns over the Risperdal side effect of male breast growth has led to a new wave of lawsuits.

In the September issue of The Journal of the American Academy of Child and Adolescent Psychiatry, a study suggested there may be some merit to using Risperdal to treat ADHD. The article described some success in treating aggression and irritability seen in ADHD when used as part of a three-pronged treatment approach. In this study, Risperdal was combined with another drug, Concerta, and behavioral management training for the children’s parents. In the study, researchers split a group of about 170 children into two groups. One group received the standard (researchers called it “basic”) ADHD treatment, while the second group was treated with Risperdal, Concerta, and had their parents receive behavioral training. While both groups showed signs of improvement, the group that received the three-pronged treatment showed greater improvement.

However, researchers stressed that the safety of treatment with Risperdal and Concerta needed to be evaluated further before they could recommend widespread use of this treatment, in light of gynecomastia concerns.

The Risperdal Gynecomastia Lawsuit is In re: Risperdal Litigation, Case No. 100300296, in the Philadelphia Court of Common Pleas.