Risperdal is an antipsychotic drug. The active ingredient in Risperdal is risperidone. Risperidone affects levels of dopamine and serotonin, which are neurotransmitters that affect mood and behavior in the brain. Risperdal is used to treat schizophrenia and symptoms of bipolar disorder in adults. In children, Risperdal is also used to treat irritability associated with autism.
Risperdal is a product of Johnson & Johnson’s subsidiary Janssen Pharmaceuticals, Inc. Risperdal and Riperdal M-Tab are brand names for the drug, both of which have the generic name risperidone.
Risperdal has been linked to the development of gynecomastia in young males, a condition marked by the excess development of male breast tissue. According to risperidone lawsuits, as noted below, symptoms of male breast growth associated with Risperdal may include swollen breast tissue, tenderness in the breast, pain in the breast, and nipple discharge from one or both breasts.
Facts about Risperdal:
- Risperdal was first approved by the U.S. Food & Drug Administration (FDA) in the United States in 1993, specifically for the short-term treatment of schizophrenia in adults. In 2003, the FDA approved Risperdal for the short-term treatment of adults with acute manic or mixed episodes associated with extreme mood swings. In 2006, the FDA approved Risperdal for the symptomatic treatment of irritability in autistic children and adolescents. Therefore, Risperdal was not approved for use in children until 2006.
- Risperdal may also be used as a treatment for ADHD (Attention Deficit Hyperactivity Disorder); however, this is an off-label use that has not been approved by the FDA.
- In 2006, the Journal of Clinical Psychopharmacology published a study finding that the use of risperidone in children was associated with excessive levels of the hormone prolactin, which can be tied to breast development and lactation. In 2009, the Journal of Child and Adolescent Psychopharmacology found that high levels of prolactin could persist for as many as two years while on risperidone.
- In October 2012, Johnson & Johnson settled five Risperdal lawsuits for injuries caused to children who had allegedly suffered from male breast growth. Additional Risperdal gynecomastia suits continue to be filed. To date, more than 420 lawsuits have been filed against Johnson & Johnson.
- In November 2013, Johnson & Johnson came to a settlement agreement of over $2.2 billion dollars with the U.S. Department of Justice. According to the DOJ’s investigation, Johnson & Johnson allegedly marketed Risperdal off-label by promoting the use of the drug for uses not approved as safe and effective by the FDA, as well as provided kickbacks to doctors and pharmacists for prescribing Risperdal to their patients.
If you or a loved one has taken or is taking Risperdal and suffers from gynecomastia or related symptoms, including male breast growth, excess breast tissue, swollen breast tissue, tenderness in the breast, pain in the breast, lactation, or nipple discharge from one or both breasts, find out how Johnson//Becker PLLC can help you. Please either call us at our toll free number (800) 279-6386 or fill out our case review form here on our website, and submit it for a free consultation.