Unfortunately, those off-label prescriptions may occur much more often than they should — given the panel’s judgment. This may have happened because of two key issues covered in the Risperdal lawsuits. One, Johnson & Johnson, the manufacturer of Risperdal, may have concealed the drug’s associated risks from patients and doctors. Two, Johnson & Johnson’s Janssen Pharmaceuticals, the division that marketed Risperdal, may have illegally marketed Risperdal for use in children before the drug was even approved for children in 2006, thus starting the practice that has now been advised against by federal drug experts of prescribing Risperdal for behavioral problems in children.
The off-label versus approved treatment applications and age groups for Risperdal are complicated to get a handle on, so we’ll go over them quickly:
For children between the ages of 5 and 16, Risperdal is approved for the treatment of irritability associated with autistic disorder.
For adolescents, Risperdal is approved for the treatment of schizophrenia (for ages 13-17), bipolar disorder (for ages 10-17) and irritability associated with autistic disorder (for ages 5-16).
For adults, Risperdal is approved for the treatment of schizophrenia and bipolar disorder.
In terms of off-label applications, Risperdal is sometimes used to treat sleep difficulties, anxiety and depression as well as ADHD and behavioral problems in children and adolescents.
Now — concerning the development of male breast tissue.
Risperdal has been shown to significantly increase the level of prolactin — a hormone required for female milk production — in the body. The hormone prolactin may also cause gynecomastia, an enlargement of breast tissues in males.
This physical affect may occur for whatever treatment Risperdal was prescribed for — either on or off-label. From schizophrenia to sleep difficulties, Risperdal may cause breast development in males, especially adolescent males.
As if adolescence wasn’t already a difficult enough time for boys!