Risperidone (trade name Risperdal) is an atypical antipsychotic that is prescribed to adults and children alike for extreme mental disorders such as schizophrenia, bipolar disorder, and autism. In recent years, Risperidone and its manufacturer have come under fire for failing to warn parents about a potential side effect in young boys called gynecomastia.

Gynecomastia is the abnormal development of breast tissue growth in males, which can typically be attributed to imbalanced prolactin levels. Prolactin is the hormone primarily responsible for breast development in girls, but is produced naturally in both genders during the crucial period of development in adolescence.

Janssen Pharmaceuticals and its parent company, Johnson & Johnson, are facing hundreds of Risperidone and Risperdal lawsuits, each alleging that their product caused plaintiffs to develop male breast growth, nipple pain, nipple discharge, and other symptoms of gynecomastia.

Risperidone is most commonly prescribed for adolescent schizophrenia, bipolar disorder, and certain types of autism for pediatric patients. It is used among all ages of patients due to the lack of mental strain it puts on the patient’s emotional state. This is because Risperidone works by channeling the brain chemical dopamine, which is primarily responsible for managing the brain’s pleasure and reward sensors. Despite the drug’s popularity, the high profit level does not make Risperidone or Janssen Pharmaceuticals immune to public scrutiny or product liability lawsuits.

As a subsidiary of one of the world’s largest pharmaceutical companies, Johnson & Johnson, Janssen Pharmaceuticals earns approximately $40 billion a year from Risperidone prescriptions. Janssen has been subjected to multiple fines and penalties from federal government agencies over its allegedly improper marketing tactics used to sell Risperidone.

Risperidone was originally approved by the FDA in 1993 but was not approved to treat children until 2006. Despite this fact, Janssen allegedly marketed Risperidone to treat children soon after its original release date, without knowing the side effects it could have on adolescent users. While it is perfectly legal for physicians to prescribe medications for off-label purposes, it is not legal for companies to market drugs for those reasons.

According to legal sources, the first Risperdal/Risperidone gynecomastia lawsuit was filed in 2012 by a young man who had been prescribed the drug from 1999 to 2004; he was nine years old when his prescription started. Since then, hundreds of other young men and their parents have filed legal action against Janssen for similar injuries. According to expert witnesses, gynecomastia often has to be treated with surgery, with some victims requiring therapy afterward to deal with the psychological trauma of having male breasts.

Overview of Risperidone Gynecomastia Complications

As mentioned before, gynecomastia is typically caused by an imbalance of prolactin levels in young boys. However, medical experts are unsure how this condition occurs or how the prolactin levels become mismanaged to begin with.

It is no different with Risperidone, as medical experts are unsure as to why it increases prolactin levels in boys, to the point where some Risperidone users have grown breasts as large as D-cups. However, some medical experts do have a hypothesis for this occurrence, which is directly linked to Risperidone’s treatment mechanism.

Along with regulating the reward sensors of the brain, dopamine also affects the pituitary gland. The pituitary gland is responsible for manufacturing and regulating hormones inside the patient’s body, including prolactin, which means that by interfering with the dopamine channel it could be causing confusion for the pituitary gland. Ultimately, this results in a large production of prolactin and the development of male breasts.

Beyond dealing with the physical side effects of gynecomastia, these young patients also must deal with the emotional trauma and discomfort from having large amounts of breast tissue. Until they undergo breast removal surgery, these patients are forced to adjust to their so-called “man boobs.” However, experts warn that even with the excess breast tissue removed, it is possible for lingering side effects like nipple discharge or lactation.