Study Reveals Psychological Effects from Risperdal Gynecomastia

In 2006, the FDA approved the use of Risperdal for treating irritability associated with autism in children and adolescents, and in 2007, for treating schizophrenia and bipolar disorder in the same group. Post-marketing reports associated with the medication, however, indicated that some patients were suffering from serious Risperdal side effects. These included gynecomastia, a condition that causes boys and young men to experience abnormal growth of breast tissue.

Now, a new study published in Plastic and Reconstructive Surgery indicates that gynecomastia can have adverse psychological effects in boys, negatively impacting their self-esteem and emotional health. The results may provide additional evidence for plaintiffs involved in Risperdal lawsuits.

Study raises concerns about Risperdal side effects

For the study, researchers from the Boston Children’s Hospital administered a series of psychological tests to 47 healthy boys, with an average age of 16.5 years. All were being evaluated for gynecomastia. The results were then compared to those gathered from boys who did not have any abnormal breast growth.

The study authors reported the following:

• 62 percent of the boys with gynecomastia had mild to moderate breast enlargement
• Patients with gynecomastia had lower scores on a standard quality of life assessment
• Gynecomastia patients had lower scores for general health, social functioning, and mental health
• Gynecomastia patients also had lower scores for physical health, though this was attributed to being overweight
• Breast enlargement was associated with lower scores for self-esteem

“Merely having gynecomastia was sufficient to cause significant deficits in general health, social functioning, mental health, self-esteem, and eating behaviors and attitudes compared with controls,” said Dr. Brian I. Labow, lead author of the study. He added that early intervention and treatment may be necessary to improve physical and emotional symptoms.

The study also noted that historically, treatment for gynecomastia in boys has been regarded as a cosmetic procedure, not covered by insurance. Only 35 percent of the boys undergoing surgery to correct the problem were covered by insurance.

Studies indicate risk of Risperdal side effects

Risperdal (risperidone) is an antipsychotic medication developed by Ortho-McNiel Janssen, a subsidiary of Johnson & Johnson (J&J). In 2010, The Department of Justice, state attorneys general, and other plaintiffs filed a lawsuit claiming the companies had promoted the drug for off-label uses not approved by the FDA. J&J has denied any wrongdoing, but has paid millions in settlements to investors and various states for similar claims.

Some studies have indicated that treatment with Risperdal may increase risk of gynecomastia. In 2009, researchers published results in Psychoneuroendocrinology showing that risperidone created higher levels of prolactin—a hormone that stimulates milk production—in patients treated for schizophrenia. A later study published in 2012 in the Journal of Child and Adolescent Psychiatry reported that long-term treatment with risperidone could boost levels of prolactin.

Injured patients file Risperdal lawsuits

In September 2012, Bloomberg reported that more than 400 Risperdal lawsuits had been filed throughout the country, including 130 cases that involved allegations of gynecomastia. All plaintiffs alleged that J&J failed to provide adequate warnings about Risperdal side effects.

J&J agreed to a settlement on the first day of trial in one case that was filed in Philadelphia. Plaintiff Aron Banks claimed the drug caused boys to grow breasts. The terms of the settlement were kept confidential.