Risperdal (risperdone), manufactured and distributed by Johnson & Johnson and its Janssen Pharmaceuticals unit, was FDA approved in 1993 to treat schizophrenia in adults.

In August 2007, the agency approved it for the same use in children ages 13-17, as well as to treat bipolar disorder and autism spectrum disorders in children ages 10-17.

However, the medication has been linked to serious side effects including male breast growth. Extensive research linking use of Risperdal to male breast growth has been published in the U.S.

In 2006, a study by Duke University researchers was published in the Journal of Clinical Psychopharmacology. Results showed that adolescents who took Risperdal exhibited significantly higher levels of “prolactin,” a hormone that stimulates breast development in women.

A 2007 study found that low-to-intermediate doses of risperidone induced a four-fold prolactin increase in children. By 2008, some doctors were raising concerns that the drug was causing troubling side effects in young boys.

The Wall Street Journal reported incidences of Risperdal male breast growth in young men (gynecomastia), with some requiring mastectomies to treat the problem. A later study, in 2009, found that after treatment with Risperdal, elevated prolactin levels persisted for up to two years in children and adolescents.

The following symptoms have been associated with Risperdal gynecomastia, and have been alleged in a growing number of lawsuits over the medication:

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

Risperdal Lawsuits & Settlements

As plaintiffs who allegedly experienced these Risperdal side effects continue to come forward, Johnson & Johnson’s marketing of Risperdal and some other drugs has come under fire. Though most cases are still going through pre-trial proceedings, some have already been resolved through a Risperdal settlement.

In 2012, for example, Johnson & Johnson agreed to a settlement with plaintiff Aron B., who had sued the company over claims that the anti-psychotic drug had caused him and other boys to suffer gynecomastia (enlarged breasts). The Risperdal lawsuit was one of over 400 filed at the time, and one of over 100 claiming this particular side effect.

The settlement was reached on what was supposed to be the first day of trial before a Philadelphia jury, with the terms kept confidential.

Additionally, on Nov. 4, 2013, the FDA issued a news release stating that Janssen Pharmaceuticals (the division of Johnson & Johnson that manufacturers Risperdal) had agreed to pay over $1.6 billion to resolve allegations of misbranding and filing false claims for the drug.

Victims of Risperdal who have experienced a gynecomastia diagnosis and painful or swollen breasts, which may have resulted in a mastectomy or liposuction to remove breast tissue caused by the medication, may be eligible to recover damages for their pain and suffering by filing a Risperdal lawsuit.