It Was the Breast of Times, It Was the Worst of Times for Risperdal Patients

Vancouver, BCIt’s hard to ignore a medical study that involves a million participants. However, that was the size of the database researcher Mahyar Etminan, PharmD and his team at the University of British Columbia (UBC) in Vancouver used in determining that Risperdal side effects, and specifically gynecomastia, can impact older men to the tune of 69 percent.

“This is the first and largest epidemiologic study on this question using data from 1 million men in the United States,” said Dr. Etminan, who is also a drug safety researcher in the Therapeutic Evaluation Unit at Provincial Health Services Authority of British Columbia, in comments published in Medscape Medical News (3/17/14). “There has been a lot of interest on the risk of gynecomastia 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,” said Dr. Etminan.

Risperdal (risperidone) is an atypical antipsychotic that is prescribed for a variety of issues, not the least of which pertains to attention deficit disorders in adolescents and young adults. As a result, many male adolescents and young men have been experiencing growth of male breasts (gynecomastia), treatment for which is often surgery to remove the offending tissue.

Many a Risperdal lawsuit has originated from gynecomastia, which can affect an individual’s self-esteem and social interaction with peers.

Other side effects include Risperdal diabetes and Risperdal stroke; however, gynecomastia appears to be the side effect that attracts the most attention due to the physiological changes risperidone can drive toward a patient.

Medscape Medical News reports that the research undertaken by Dr. Etminan and his team is currently in the process of peer review prior to publication in medical journals. However, a presentation earlier in the spring to the annual general meeting of the American Association of Geriatric Psychiatry (AAGP) in Orlando was well received.

The focus here was gynecomastia on older men. Investigators examined information from the IMS LifeLink Health Plan claims database for 1 million men in the US between the ages of 45 and 80 years who made claims between 2001 and 2011. Within this group, 8,285 cases of gynecomastia were identified. In addition, 10 men who did not have gynecomastia were matched to each man who did have the condition and were included as the control group (n = 82,850).

Mean age for both the patients with gynecomastia and the control group was 65.5 years - hence the focus on older men for the purposes of the study.

Dr. Etminan, however, is cognizant of the possibility for gynecomastia in younger men and male adolescents, and cautions doctors to consider prescribing alternatives to Risperdal, such as quetiapine or olanzapine.

It may be rare, but it’s there…

There have been other studies with regard to Risperdal male breasts, so the information is not new. However, Iqbal Ahmed, MD, clinical professor of psychiatry and geriatric medicine at the University of Hawaii at Manoa, told Medscape Medical News that the larger dataset carries some significance.

“It was fairly consistent with what we already know about Risperdal,” he said, in published comments. “Among antipsychotics, it’s most likely to cause gynecomastia in some men, probably because of higher prolactin levels. I think it’s a confirmatory poster with a larger dataset rather than just clinical experience.”

Dr. Etminan echoed the fact that having such a large dataset allowed them to arrive at some significant conclusions for what is still generally held as a rare adverse incident. “Because we had a million men in our population, we were able to pick [gynecomastia] up.”

Etminan went on to say that doctors and clinicians with younger patients in need of an antipsychotic, might well be advised to consider an alternate medication for their patients. “If everything is the same in terms of efficacy in these antipsychotics, especially for younger men who may have more problems with this psychologically, then I think it may be better to choose something other than risperidone.”

And while rare, the Risperdal gynecomastia portfolio appears nonetheless a concern to the manufacturer of Risperdal, given that previous lawsuits have been quickly settled before they progressed to trial. The media also has a tendency to exploit young gynecomastia patients willing to tell their story, so others won’t have to suffer the same indignation and stigma from Risperdal male breasts.

Many a Risperdal patient has contacted their Risperdal attorney, to put the wheels in motion for a Risperdal lawsuit. As Dr. Etminan’s research is peer reviewed and published - and with Risperdal increasingly prescribed for attention deficit disorders - the issue will take on even greater significance, if indeed that significance is carefully hidden behind a young man’s buttoned shirt.

“If you want to put it in perspective, there are millions of prescriptions of Risperdal prescribed, Etminan concludes. “But everything else being equal, then why not prescribe something else if there is a risk for gynecomastia?”