Many of us have heard of Risperdal (Risperidone) in the news recently. In November 2013, Johnson & Johnson, the manufacturer of this powerful antipsychotic drug, is set to pay $2.2 billion dollars in civil and criminal settlements for allegedly off-label marketing the drug by promoting it for uses not approved by the FDA. This is the third largest pharmaceutical settlement in history. However, that is not the end of Risperdal’s story.
The attorneys at Ashcraft and Gerel are investigating potential lawsuits on behalf of boys and young men who have developed gynecomastia, an irreversible disease in which males develop breasts, after using Risperdal.
The drug Risperdal (Risperidone), manufactured by Johnson & Johnson, is prescribed to treat psychiatric disorders including schizophrenia, bipolar disorder and behavioral problems in people with autism. The FDA first approved Risperdal in 1994 for the treatment of schizophrenia. In 2006 and 2007, the FDA approved the drug for use in treating other psychological disorders.
Risperdal has been shown to produce gynecomastia, or the development of male breasts, in boys and young men who have taken the drug. Symptoms of gynecomastia include:
- Asymmetrical breast enlargement
- Swollen nipples
- Nipple discharge
- Breast tenderness
- Redness or discoloration around the nipple
Gynecomastia is a potentially embarrassing condition that can cause major psychological trauma and lowered self-esteem to those afflicted with it. Some may even require surgery in order to remove the excess breast tissue. In less serious cases, liposuction could be performed. In other cases, however, a full mastectomy is required, which involves the complete removal of breast tissue and excess skin. In addition to the expense of these procedures, they can also cause psychological stress and anxiety.
Scientific studies have proven that Risperdal increases levels of prolactin, a hormone that stimulates breast development. As a result, young boys who have been exposed to prolactin may develop male breasts with pain or nipple discharge. A study in the 2006 issue of the Journal of Clinical Psychopharmacology states that when Risperdal is administered in usual doses, it can “strongly increase prolactin levels, with clinical consequences such as gynecomastia.” Although the potential for gynecomastia from taking Risperdal is now well-understood, the long-term effects of Risperdal are not well known. Risperdal could potentially impact boys’ development and puberty.
Current Risperdal labeling warns that unusual breast growth could be a side effect of taking the drug. However, when the FDA first approved Risperdal, Johnson & Johnson provided insufficient warnings that their product could cause gynecomastia in a large percentage of people who use it. As a result, many boys have experienced harmful physical and psychological side-effects. Hundreds of people across the country have already filed lawsuits against Johnson & Johnson for their failure to warn consumers and healthcare providers of the potential for Risperdal to cause gynecomastia and other side effects.
In September 2012, Johnson & Johnson reached an agreement to settle one such case on the first day of trial in Philadelphia state court, but the amount of the settlement remains confidential. Those who have filed Risperdal lawsuits are requesting monetary damages for hospital expenses, surgical costs, mental anguish and other damages. If you feel that you, or someone you know, should be compensated for side effects caused by Risperdal, please contact us online or call us at 800-829-7037 to speak with a Risperdal attorney today. All consultations are free and completely confidential.