One of the most popular antipsychotics in the United States is being linked to several severe side effects, including gynecomastia symptoms. Many young boys and their parents are claiming that soon after taking Risperdal, their children developed male breast tissue and growth.

Risperdal (Risperidone) was approved by the FDA in 1993, to treat schizophrenia and bipolar disorder in adult patients. It is manufactured by Johnson & Johnson’s subsidiary, Jansen Pharmaceuticals, earning the company millions for decades.

In 2006, Risperdal was approved to treat children who were suffering from schizophrenia, bipolar disorder, and certain types of autism. However, it has been alleged that Jansen had been selling Risperdal for pediatric treatment long before it was approved for that purpose, with sales records dating back to 1994.

Soon after the release of Risperdal, Johnson & Johnson had noticed a significantly high number of pediatric prescriptions, for off-label treatment purposes. By definition, off-label treatment for a drug means to use the drug for any reason not approved by the FDA. At the time, children being prescribed Risperdal was off-label.

Instead of warning doctors that Risperdal had not sufficient pre-clinical testing on children, Johnson & Johnson had capitalized on that target market. While it is not illegal for doctors to prescribe a medication for off-label purposes, it is illegal for drug companies to advertise them for such purposes.

Even before its official approval in 2006, parents with children suffering extreme mental disorders had thought they found relief in Risperdal. Risperdal is an atypical antipsychotic that works by managing the brain chemical dopamine, which control the brain’s pleasure and reward sensations.

Compared to traditional antipsychotics that work by leveling the brain’s entire chemistry, Risperdal provided less emotional side effects and more enjoyment in the patient’s life.

However, Risperdal came with a number of unusual and severe side effects, including gynecomastia symptoms. Many of these patients and their parents complained that Risperdal’s warning label did not describe the male gynecomastia risk, and that Jansen made no effort to notify them of the side effects.

Overview of Risperdal Side Effects

There are a number of severe side effects that can occur with taking any drug, and Risperdal is no different. As mentioned before, male gynecomastia is the most infamous of Risperdal side effects, but it is important to note that patients can suffer other adverse events.

In a similar complication to gynecomastia symptoms, Risperdal can cause the pituitary gland to have an increased production of prolactin, which is not only responsible for female breast development, but can also cause the pituitary gland to grow. When the pituitary gland grows and focuses on only prolactin, it causes the production of other hormones to be disrupted, which leads to pituitary tumors. While usually benign, these tumors can lead to other health problems like vision issues, internal bleeding, headaches, and seizures.

In the case of male gynecomastia, the pituitary gland’s enlargement can also lead to the abnormal development of male breasts. While medical experts are unsure as to what exactly causes gynecomastia, it is almost always due to a hormone imbalance.

In particular, gynecomastia is typically caused by an overabundance of prolactin, which is responsible for male breast development and the sex drive in males. The pituitary gland also manufactures dopamine for the body, which Risperdal directly interferes with. Medical experts suspect that by blocking the dopamine channel, it interferes with the body’s natural hormone management process.

Each of these Risperdal gynecomastia symptom complaints are from young boys and their parents. Medical experts explain that male gynecomastia is occurring in this patient population due to the fact that these patients are often going through puberty, which is compounded in complexity due to Risperdal.

These side effects have led to hundreds of Risperdal gynecomastia lawsuits, with the plaintiffs alleging that Johnson & Johnson knew about the risk of gynecomastia but chose not to inform the public.