Male breast growth, a condition known as gynecomastia, has been seen in boys taking the drug Risperdal. The condition is usually permanent, and in most cases, boys with Risperdal-associated gynecomastia must undergo breast reduction surgery or mastectomy to correct theproblem.
These surgical procedures are painful. And the psychological problems suffered by many of these Risperdal victims can be even more difficult. That is why many families of these boys have chosen to file lawsuits against Janssen, the maker of Risperdal. According to a recent CBS News report, such lawsuits claim Janssen marketed Risperdal for unapproved uses in children, and downplayed serious side effects. These lawsuits point out that breast growth wasn’t even mentioned under the “Warnings” section of the Risperdal label, but was only listed under “Precautions.” They also allege that the language regarding gynecomastia in the Risperdal label was worded in “obscure” terms.
Risperdal causes a release of prolactin from the pituitary gland. Prolactin is a hormone that stimulates breast development and lactation. Recently, a report aired on CBS News that discussed the problem of gynecomastia in boys taking Risperdal. The boys highlighted in the CBS News report were often being given Risperdal off-label to treat behavioral problems like Attention Deficit Hyperactivity Disorder (ADHD).
It is not clear how often boys taking Risperdal suffer from male breast growth. In 2008, Duke University psychiatrist P. Murali Doraiswamy told The Wall Street Journal that Risperdal had the strongest link with gynecomastia in children and adolescents of any of the newer antipsychotic drugs–accounting for 70% of the cases analyzed. He has also found that some girls taking Risperdal begin to lactate before they reach puberty. In 2006, Doraiswamy co-authored of a study on antipsychotics and prolactin with FDA scientist.
According to CBS, Janssen found that in a clinical trial it conducted involving fewer than 2,000 children, 43 developed the abnormal breasts.
Risperdal was originally approved by the Food & Drug Administration (FDA) in 1993 to treat schizophrenia in adults. Later, its approved uses were expanded to include bipolar disorder I in adults, as well as irritability associated with autistic disorders in children from 5 to 16 years of age. Then in August 2007, Risperdal was approved for treatment of schizophrenia in adolescents aged from 13 to 17, as well as the short term treatment of manic or mixed episodes of bipolar I disorder in children aged between 10 and 17. It is not approved as a treatment for ADHD, though it is often prescribed off-label to treat children with the condition.
