Austin Pledger and his family’s $2.5 million victory over Johnson & Johnson subsidiary Janssen Pharmaceuticals for withholding side effects data with its antipsychotic drug Risperdal is hardly cause for celebration. Pledger, now 20, needs a mastectomy to remove the DD-sized breasts he grew after taking the drug as an adolescent.
Risperdal, known generically as risperidone, is now approved for adults and children with schizophrenia, bipolar disorder and irritability with autism. It is often prescribed off label for behavior disorders including ADD and ADHD.
Pledger began taking Risperdal in 2002 to treat symptoms of autism. He was just 8 at the time. Risperdal hit the market in 1993 but was not approved for use in children until 2006. Yet, a Janssen sales representative had made more than 20 visits to the pediatric neurologist treating Pledger.
Doctors are at liberty to prescribe drugs for unapproved uses, but pharmaceutical companies cannot market drugs for so-called off-label use. Janssen has since paid $2.2 billion to settle a federal lawsuit for illegally promoting Risperdal such as for use in children.
In all its efforts to expand use of Risperdal, Janssen failed to share with doctors side effects data especially in the pediatric population. The data showed that Risperdal causes increases of prolactin in the body, a hormone that is best known for its role in stimulating breast development and milk production. This can cause a condition in boys and men known as gynecomastia.
Janssen did not add the warning to the drug’s label until 2006. As a result, more than 1,250 Risperdal lawsuits are pending in courts throughout the country, most of which are related to abnormal breast growth in boys and young men, a condition known as gynecomastia.
Gynecomastia can be both emotionally and physically painful, especially for adolescent boys. In some cases, such as Pledger’s, the breasts do not go away after treatment has stopped, requiring patients to undergo surgeries including liposuction and/or mastectomy to remove the breasts.
Source: Mad in America