New research presented at the American Association for Geriatric Psychiatry 2014 Annual Meeting suggests that there is a higher risk of gynecomastia with Risperdal (risperidone) users than non-users. Researchers found that older men taking the antipsychotic drug were 69 percent more likely to have breast enlargement compared to those who did not. The researchers also found evidence that there is a higher risk of gynecomastia with Risperdal compared to other antipsychotics.
“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 a drug safety researcher in the Therapeutic Evaluation Unit at Provincial Health Services Authority of British Columbia and an assistant professor at the University of British Columbia, Vancouver.
The researchers looked at data from the IMS LifeLink Health Plan claims database. Among 1 million men in the United States between the ages of 45 and 80 who made the claims between 2001 and 2011, 8,285 were identified as having gynecomastia. Ten men who did not have the condition were matched to each man who did as a control group. The mean age of both groups was 65.5 years.
“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. “So we wanted to see if there was actually a risk with Risperdal that is over and beyond the other antipsychotics. We do know that these drugs in general can cause gynecomastia because of the way they change the hormones in the body. But we weren’t really sure whether Risperdal does it more than the others.”
There was a trend in the data suggests that Risperdal increased the risk of gynecomastia compared with paliperidone or quetiapine. Etminan noted that “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,”
Although the study was only done on older men, Dr. Etminan emphasized that the condition can occur in younger boys. This factor may be especially important if the drugs are equal in efficacy, he says, because the psychological effects may be more problematic in younger men.
There are hundreds of lawsuits alleging that Risperdal caused gynecomastia. In 2012, Johnson & Johnson reached the first settlement; the lawsuit was filed on behalf of a 21-year old man alleging that the drug led to breast enlargement and subsequent surgical removal. Shortly afterwards, five more lawsuits were settled.