Risperidone, known as Risperdal, has been approved by the Food and Drug Administration (FDA) as a treatment for schizophrenia, bipolar disorder, and irritability in individuals who have autism. While this treatment is approved for adults and adolescents, Risperdal has often been prescribed to treat attention deficit hyperactivity disorder (ADHD) in children. Other medical providers have prescribed Risperdal for problems including anger management issues, dementia, and anxiety, all of which are considered off label uses. Other side side effects include excessive weight gain, gynecomastia (growth of male breast tissue), diabetes, and more. Some children have needed surgery and long-term medical care for these potentially permanent side effects.
Pharmaceutical Company Promoted Risperdal for Off-Label Uses Despite Side Effects
Risperdal was approved in 1993, launched in 1994, and lost patent protection in 2008. The FDA approved Risperdal for pediatric use in 2006, but almost 1,300 personal injury lawsuits have been filed by families whose young children, especially boys, were prescribed Risperdal to treat autism or psychosis well before it was approved for pediatric use. According to many of these lawsuits, J&J and Janssen began marketing the drug to pediatricians as early as 1999.
In 2012, Justice Department settled an off-label Risperdal lawsuit with J&J for $2.2 billion, which resolved claims that Johnson & Johnson and their subsidiary Janssen promoted Risperdal for off-label and unapproved uses between 1999 and 2005, such as controlling aggression in elderly dementia patients, as well as behavioral disturbances in children. Risperdal has not been approved for use in elderly patients with dementia-related psychosis.
Risperdal Alleged to Cause Growth of Breast Tissue in Young Boys
According to testimony in the first Risperdal bellwether trial, Johnson & Johnson knew as early as 2001 that its antipsychotic drug had serious, dangerous side effects, including that it could cause gynecomastia (female breast tissue growth) in young boys. Former FDA Chief Richard Kessler testified that a 2001 study conducted on Risperdal showed that 3.8% of boys using the drug grew breasts. That was five years before J&J put a warning label on Risperdal that the drug could have psychologically and physically damaging side effects like gynecomastia.
The Strom Law Firm, L.L.C. is investigating cases on behalf of individuals who have suffered life altering side effects of Risperdal.
If you or a male loved one were prescribed Risperdal and suffer any of the following side effects:
- swollen breast gland tissue
- tenderness in one or both of the breasts
- swollen nipples
- darkened or reddish skin around the nipples
- metabolic changes leading to weight gain
You may have developed gynecomastia or other side effects from your Risperdal prescription. Contact us today for a free consultation. You may may be elligible for surgical bills, hospital expenses, mental pain and suffering, and other damages. Contact us today to see if we can help (803) 252-4800.