Risperdal Gynecomastia Side Effects Cause Breast Growth in Young Males: Study

The findings of new research add to the body of evidence indicating that side effects of Risperdal use among boys or young men may increase the risk of abnormal breast growth, known as gynecomastia. 

In a study published last month in the Journal of Child and Adolescent Psychopharmacology, researchers from the University of British Columbia indicate that use of Risperdal may increase the risk of gynecomastia breast growth in teens and young men by a factor of four.

Risperdal (risperidone) is a popular antipsychotic medication, which is widely used among children for treatment of schizophrenia, bipoloar disorder and irritability associated with autism. However, side effects of the medication have been linked to an increase in the amount of the hormone prolactin in the blood, which is a protein hormone that induces and maintains lactation in women after they give birth. For boys and young men using Risperdal, prior research has suggested that this may result in the development of enlarged breasts.

In this latest study, researchers evaluated data on more than 400,000 males ages 15-25, using the IMS LifeLink database. They found 1,556 cases of gynecomastia and compared them with 15,560 corresponding controls.

According to the findings, Risperdal users were 3.91 times more likely to develop gynecomastia than boys and young men who did not take the drug. When researchers looked just at those under the age of 18, the risk increased to more than a factor of five.

“Our study showed a strong association between risperidone use and gynecomastia in young adult males,” the researchers concluded. “Clinicians who are prescribing risperidone to this demographic may need to consider this adverse event in their therapeutic decision-making process.”

Johnson & Johnson currently faces more than 1,300 product liability lawsuits over failure to adequately warn about the Risperdal gynecomastia side effects, alleging that the drug maker withheld known information about the risk from consumers and the medical community.

According to evidence presented in the litigation, Johnson & Johnson has allegedly known about the link between Risperdal and gynecomastia since at least 2001, yet chose not to update warnings provided to parents about the male breast growth risks for years.

In February 2015, the first Risperdal bellwether trial in Pennsylvania state court ended in a $2.5 million jury award, with a second case the following month ending with a defense verdict. While that second jury found that the plaintiff failed to establish that his abnormal breast growth was caused by the medication, the same jury determined that Johnson & Johnson failed to adequately warn the boys and their parents about the gynecomastia risks.

A third bellwether case was settled out of court in May.

While the outcomes of these early trials are not binding on other claims, they are being closely watched by lawyers involved in the litigation, as they may influence negotiations to reach Risperdal settlements for gynecomastia that would avoid the need for hundreds of individual trials to be scheduled.