Antipsychotic Drug Risperidone May Increase Risk of Gynecomastia, New Research SuggestsMar 26, 2014
Risperidone, a second-generation antipsychotic medication sold as Risperdal by J&J unit Janssen Pharmaceuticals, Inc., may increase the risk of breast enlargement in men, according to new research. The condition, known as gynecomastia, was 69 percent more likely to develop in older men taking Risperdal compared to nonusers. Data also suggests that there is higher risk of gynecomastia with Risperdal compared with olanzapine or quetiapine.
Researchers reviewed national health claims data to look at the risk of gynecomastia in Risperdal users compared to nonusers and users of other antipsychotics. According to Medscape, the results were presented at the American Association for Geriatric Psychiatry 2014 Annual Meeting.
Investigators used information from the IMS LifeLink Health Plan claims database for 1 million men in the United States between the ages of 45 and 80 who made claims between 2001 and 2011; among these, 8,285 had gynecomastia. For a control group, researchers matched 10 men who did not have the condition to each did. The mean age of both groups was 65.5 years.
"This is the first and largest epidemiologic study on this question using data from 1 million men in the United States," said lead author Mahyar Etminan, PharmD. Dr. Etminan is an assistant professor at the University of British Columbia, Vancouver and a drug safety researcher in the Therapeutic Evaluation Unit at Provincial Health Services Authority of British Columbia.
Results also show a trend suggesting that gynecomastia is more likely to occur with Risperdal compared with paliperidone or quetiapine. "Statistically, this wasn't significant, which means we didn't have enough power or enough people in this study. But the trend was definitely there," Dr. Etminan noted. He also cautions that the condition can occur in younger boys, even though the study only looked at older men.
There are lawsuits pending over whether Risperdal caused gynecomastia in some men. The first settlement over one of these cases occurred in 2012, when Johnson & Johnson settled a 21-year old man’s allegations that the drug led to breast enlargement and subsequent surgical removal. Shortly afterwards, five more lawsuits were settled. There are currently hundreds of cases pending over the issue.
"There has been a lot of interest on the risk of gynecosmastia with Risperdal, mainly in adolescent boys but also in older men. There have been reports to the FDA [US Food and Drug Administration] and case reports from academics," Dr. Etminan said.