Risperdal (risperidone) is a second-generation antipsychotic, also known as an atypical antipsychotic. It is approved for treatment of treat schizophrenia, bipolar disorders, and autism spectrum disorders. It has also been prescribed off-label to treat attention deficit hyperactivity disorder (ADHD) in children. Risperdal has been linked to numerous serious side effects, including gynecomastia, the development of male breasts.
The U.S. Food and Drug Administration (FDA) approved Risperdal to treat the following conditions:
- Schizophrenia in adults and adolescents
- Bipolar disorder in adults and adolescents
- Autism spectrum disorder in children and adolescents
Off-label refers to uses that are not approved by the FDA. Risperdal has been prescribed off-label to treat conditions including:
Doctors are allowed to prescribe drugs off-label when they believe it is in the best interests of their patients. It is illegal for drug companies to market their drugs for off-label uses. On November 4, 2013, the U.S Department of Justice (DOJ) announced that Johnson & Johnson (J&J) and its subsidiaries would pay more than $2.2 billion in criminal and civil penalties to resolve allegations of off-label marketing of drugs including Risperdal and paying kickback to doctors and a large pharmacy.
Risperdal Side Effects
Risperdal has been linked to the following side effects and injuries:
- Movement disorders
- Pituitary tumors
- Stroke in elderly patients
- Heart Problems
- Neuroleptic malignant syndrome (NMS)
- Weight gain
Risperdal has been linked to gynecomastia, when taken by boys. Gynecomastia is the development of male breasts. Risperdal use can result in elevated levels of the hormone prolactin. In females, prolactin stimulates the production of milk during pregnancy and nursing. In males, elevated prolactin causes excessive growth of breast tissue. This is not merely the growth of larger breasts due to excess fat. It is actual breast tissue which can only be corrected surgically.
Studies have found that gynecomastia can cause serious and long-term trauma to boys including damage to their:
- Self esteem
- Mental health
- Social functioning
Surgery to correct gynecomastia can be serious and carries substantial risks. Complications and permanent injuries from gynecomastia correction surgery can include:
- Changes in sensation
- Painful scarring