Risperdal is an atypical antipsychotic used to treat adolescents and adults with schizophrenia and bipolar disorder as well as irritability associated with autistic disorder in children ages 6 to 16. It is linked to the side effect of gynecomastia, or male breast growth.

Risperdal is also being used more and more as a treatment for ADHD, even though this is an off-label use that has not been approved by the U.S. Food & Drug Administration (FDA). While Risperdal has been on the market since 1996, it wasn’t until 2006 that the FDA approved the use of Risperdal in children.

The active ingredient in Risperdal is risperidone, which works by affecting the levels of dopamine and serotonin in the brain. These neurotransmitters are known to affect mood and behavior.

The issue concerning Risperdal involves children, especially boys, who allegedly developed gynecomastia due to their use of the medication. In addition to claiming the use of Risperdal caused male breast growth, Risperdal lawsuits filed on behalf of children allege that Johnson & Johnson improperly marketed the drug for pediatric use before the FDA cleared it for such purposes.

What is Gynecomastia?

Gynecomastia is a condition that causes male patients to develop breasts. Mental health professionals report that male breasts can have a significantly harmful mental and emotional effect on boys and young men, often causing shame and humiliation and deep self-hatred.

The emotional scars may last well past any surgical remedies as boys may be severely taunted by their peers and suffer emotional trauma when trying to engage in normal activities. Many doctors have reportedly recommended that adolescent males who suffer from gynecomastia undergo surgery. Mild cases can be resolved with liposuction, while more severe cases require a mastectomy.

Studies Link Male Breast Growth to Risperdal

Risperidone, manufactured by Johnson & Johnson and sold as Risperdal, is an antipsychotic drug that was first approved by the U.S. Food and Drug Administration (FDA) in 1993, and is used as a treatment for schizophrenia, mania, and irritability associated with autistic disorder in children and teenagers. Risperdal belongs to a class of drugs known as atypical antipsychotics, and works by altering certain substances in the brain.

A number of studies have indicated that use of Risperdal may cause male breast development. In 2006, one such study published in the Journal of Clinical Psychopharmacology found that the use of risperidone in children was associated with excessive levels of the hormone prolactin, which is tied to female breast development and lactation. Three years later, research published in the Journal of Child and Adolescent Psychopharmacology revealed that these high levels of prolactin could persist for as many as two years.

According to researchers, symptoms of male breast growth associated with Risperdal may include:

• Swollen breast tissue
• Tenderness in the breast
• Pain in the breast
• Nipple discharge from one or both breasts

Risperdal Gynecomastia Lawsuits

Risperdal side effects lawsuits
are being filed by, and on behalf of, men and boys who allegedly developed male breast growth due to their use of the antipsychotic drug. As of October 2012, Johnson & Johnson had already settled a handful of Risperdal claims, even as the litigation surrounding the medication continued to grow. Just a little over a year later, the company reached a settlement with the federal government to resolve charges that it improperly marketed Risperdal.