About 700 product liability lawsuits involving the antipsychotic Risperdal have been filed in Philadelphia Court of Common Pleas alleging use of the drug caused boys and young men to develop breasts, a condition referred to as gynecomastia. Many of the plaintiffs allege their conditions are so bad that they need a mastectomy, liposuction and other surgical intervention to remove the breast tissue caused by the drug.
Risperdal, also known as risperidone, is approved by the Food and Drug Administration (FDA) to treat adults and children with bipolar disorder, schizophrenia, and irritability with autism. It is frequently prescribed off-label for other conditions including Attention Deficit Hyperactivity Disorder (ADHD).
A recent study published in the Journal of Clinical Psychopharmacology found of 174 men between the ages of 40 and 85 exposed to risperidone, 27 developed breasts within two months.
The lawsuits claim that Johnson & Johnson and its subsidiary Janssen Pharmaceuticals failed to adequately warn patients and their doctors of Risperdal side effects, including gynecomastia.
The companies have already been accused of pushing the drug for unapproved uses. In November 2013, Johnson & Johnson agreed to pay $2.5 million to settle claims with the U.S. Department of Justice over off-label marketing of Risperdal, including promoting the drug for children before it was granted that indication by the FDA.
Source: Pennsylvania Record