A new study has suggested that boys who take Risperdal may be five times more likely to develop gynecomastia compared to those who are not exposed to the antipsychotic drug. The study was published online August 19th in the Journal of Child and Adolescence Psychopharmacology.
The appearance of the new research is timely, as Risperdal is the subject of hundreds of lawsuits filed on behalf of patients who allegedly developed gynecomastia due to its use. This condition is marked by the growth of female-like breasts in men, and is associated with higher-than-usual prolactin levels sometimes seen in Risperdal patients. Prolactin is a hormone tied to the female breast development and lactation.
For the study, the authors derived a cohort of more than 1,556 gynecomastia patients out of 401,924 males, ages 15–25, included in the IMS LifeLink database. Each gynecomastia subject was compared to 10 patients who did not have the condition, for a total of 15,560 controls. The controls were matched by age, follow-up date and cohort entry date.
An analysis of the data suggested that current Risperdal users had approximately four times the risk of developing gynecomastia than non-users. When the analysis was stratified to children and adolescents taking Risperdal, the risk of gynecomastia was five times higher than for non-users.
“Risperidone is associated with an increase with the risk of gynecomastia in adolescent and young adult males,” the study concluded.
The publication of this study comes as a Risperdal litigation underway in Pennsylvania prepares to convene two trials next month to test allegations involving the drug’s association with excessive male breast growth. The litigation, which is housed in the Philadelphia Court of Common Pleas, held two such trials earlier this year, the first of which ended with a $2.5 million verdict for the plaintiff. The jury in the second trial declined to award any damages for that plaintiff after it was unable to determine that Risperdal had caused his gynecomastia. However, they did find that patients and doctors were not adequately warned about its association with the condition. A third Risperdal lawsuit scheduled to go before a jury in May was settled for an undisclosed amount.