The antipsychotic drug risperidone (Risperdal) significantly increases the risk of gynecomastia in older men, a new study shows.

According to research presented this year at the American Association of Geriatric Psychiatry (AAGP) meeting, older men who use risperdone or Risperdal are 69 percent more likely to develop gynecomastia (male breast enlargement) than nonusers.

Over the last year, Johnson & Johnson and their pharmaceutical subsidiary Janssen were hit with several civil and class action lawsuits filed by young men and their families after the boys and young men developed gynecomastia allegedly caused by their use of Risperdal. Many of the Risperdal lawsuits allege that had J&J sufficiently informed their young male consumers and their parents of the increased risk of gynecomastia from Risperdal through advertisements and labeling, they would have chosen another drug to manage the male consumer’s mental conditions.

The Risperdal gynecomastia research presented at the AAGP annual meeting also demonstrated evidence that Risperdal allegedly causes gynecomastia more so than other anti-psychotic drugs in the same or similar drug category.

Study authors examined information from the IMS LifeLink Health Plan claims database for 1 million men in the United States between the ages of 45 and 80 years who made claims between 2001 and 2011. Within this group, 8,285 cases of Risperdal gynecomastia were identified.

This research comes on the heels of J&J’s recent $2.2 billion Risperdal settlement, which alleged that J&J committed illegal business practices by marketing Risperdal for off-label (that is, non-FDA approved) use. Over the next year, J&J may face an even larger number of Risperdal gynecomastia lawsuits in light of this research.

What is Gynecomastia?

Gynecomastia is a medical condition in which male breast tissue becomes unnaturally enlarged, a condition typically seen in adolescent boys. On occasion, gynecomastia occurs naturally when the young male body cannot product enough testosterone.

However, young men using Risperdal to manage mental health conditions, such as schizophrenia, bipolar mania, and occasionally autistic disorder, have a markedly higher rate of enlarged breasts allegedly due to their use of this J&J antipsychotic drug. Allegedly, the young men affected did not have a history of low testosterone and did not have a genetic predisposition for gynecomastia.

Gynecomastia is physically benign and easily operable, but can still cause great psychological stress to young men. This condition can also lead young men suffering from Risperdal gynecomastia to develop additional body image and body acceptance issues.

Some symptoms of gynecomastia include:

• Nipple discharge
• Tenderness in the breast area
• Pain in breast tissue
• Swelling which in men results in gynecomastia

History of Risperdal Litigation

J&J and Janssen Pharmaceuticals have faced multiple Risperdal gynecomastia lawsuits over the past few years. In November 2013, Janssen pleaded guilty to charges of misbranding Risperdal and filing false drug claims.

In response, the FDA had J&J pay $1.6 billion to cover Risperdal class action settlements. With the recent trend of young men and their families pursuing Risperdal gynecomastia class action lawsuits against J&J’s Janssen, it seems that the popular drug manufacturer and family brand will continue to face class action litigation in the near future.