Men and young boys who have taken the antipsychotic drug Risperdal have filed lawsuits after suffering from an adverse side effect known as gynecomastia.

These young men and boys say they have taken Risperdal and later suffered from male breast growth. This Risperdal gynecomastia is sometimes accompanied by tenderness, nipple pain, and nipple discharge.

Risperdal Gynecomastia Facts

Risperdal, also known as risperidone, was approved by the U.S. Food and Drug Administration in 2006 to treat conditions such as bipolar disorder and autism in younger patients. Before, then, it had only been approved for use in adults.

At the time, problems with Risperdal gynecomastia were less well known than they are today. Young boys and their families have recently filed Risperdal gynecomastia lawsuits, alleging these serious adverse side effects, including increased breast tissue growth.

The condition of gynecomastia is an increase in male breast growth, sometimes referred to as “man boobs.” It can be an embarrassing condition for a young patient, and it may require surgery to correct.

The exact reason why male breast growth increases due to taking Risperdal is unknown. However, what is hypothesized is that Risperdal increases the levels of a hormone, prolactin. Prolactin, also known as the luteotropic hormone or luteotropin, is known best for its role in enabling mammals, particularly females, to produce milk. It is also responsible for breast development in women during and soon after pregnancy.

Therefore, young boys and males who take Risperdal have an increased risk in suffering from Risperdal gynecomastia, in which they may develop an increase in breast tissue, nipple discharge, nipple pain, and painful breasts.

A study in the Journal of Clinical Psychopharmacology states: “Risperidone administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia and/or galactorrhea. Given that the long-term effects of antipsychotic drug-induced hyperprolactinemia are not well documented, especially regarding osteopenia, infertility, growth, and pubertal delay, risperidone should be administered with caution to children and adolescents.”

Risperdal’s manufacturer Janssen Pharmaceuticals and its parent company Johnson & Johnson have been defendants in a multitude of lawsuits, which have been filed by individual consumers and the U.S. government. Following a massive investigation, the U.S. Department of Justice accused Janssen of improperly marketing Risperdal for use in children before the FDA had approved it for such uses.

Thus far, Johnson & Johnson has paid billions of dollars in fines partly related to its marketing and advertising have Risperdal. In addition, allegations against Johnson & Johnson have purported that they concealed the side effects of Risperdal.

One Risperdal gynecomastia settlement occurred in March 2015. As reported, a jury in a Philadelphia court ordered Johnson & Johnson along with Janssen to pay roughly $2.5 million to a young man who had suffered side effects and complications due to taking Risperdal to control symptoms of autism. The plaintiff was eight years old at the time he was prescribed the medication, during which time the drug had not yet been approved for use in children.