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Risperdal Said to be Responsible for Breast Growth in Boys

Jun 25, 2009 | Parker Waichman Alonso LLP

Risperdal has been linked to breast growth, and even lactation, in boys  under 18 who take the powerful antipsychotic drug. The condition is known as gynecomastia (male breast growth), and is usually permanent.  In most cases, boys with Risperdal-associated gynecomastia must undergo breast reduction surgery, and even mastectomy, to correct the condition.

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 Attention Deficit Disorder (ADHD) though it is often prescribed off-label to treat children with the condition.

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  ADHD.

One child cited  by CBS, only age four, began developing a breast on one side of his body after he began taking Risperdal.  At that young age, his breast had even begun producing milk.  The child has undergone mastectomies to correct the problem.

Another boy, now 19, who began developing breasts as a result of Risperdal when he was 14, still  suffers psychological affects even though he underwent a double mastectomy.

It is not clear how often boys taking Risperdal suffer from male breast growth. According to CBS, the drug's maker, Janssen, found that in a clinical trial it conducted involving fewer than 2,000 children, 43 developed the abnormal breasts.  

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.  He told the Journal that the changes in hormones linked to Risperdal could not be considered harmless.

The surgery - usually a mastectomy - boys undergo to correct gynecomastia is 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.  According to CBS News, 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.