Risperdal makers Bayer Pharmaceuticals and Johnson & Johnson’s subsidiary, Jansen Pharmaceuticals, has been slammed with numerous product liability and false advertising allegations from patients who suffered from gynecomastia, or male-breast growth.

Risperdal was originally approved by the Food and Drug Administration (FDA) in 1993, as an atypical antipsychotic medication to be prescribed to patients suffering from extreme mental disorders like schizophrenia or bipolar disorder.

Its unique treatment mechanism, quickly made it popular amongst the medical community and became a preferred choice for patients. Compared to traditional antipsychotics that try to focus on stabilizing the brain as a whole, Risperdal works by channeling a single brain chemical called dopamine.

Dopamine is the primary chemical that controls the brain’s pleasure and reward sensors and is vital for mood stability. However, the treatment mechanism of Risperdal had soon shown to be a major problem that was not seen until it was prescribed to young boys.

Despite not being approved to treat children until 2007, the drug companies marketed Risperdal to children after seeing the drug’s popularity spike in younger patient populations.

It is important to note that even after the drug was officially approved to treat children, there was no research conducted to observe the drug’s effects on young parents.

However, there were a number of early studies that suggested major side effects, to which Jansen and Bayer allegedly ignored.

One of these studies was published in 1996 in the Psychopharmacology medical journal, entitled “Galactorrhea and Gynecomastia in a Hypothyroid Male Being Treated With Risperidone.”

The study observed that there was a strong correlation between Risperdal prescriptions, and male-breast growth. This study found that this abnormal development would occur just after 12 days of starting Risperdal, noting one man in his late 30s that had developed large breasts and nipple discharge.

In a later study published in the same journal in 2006, entitled “Risperidone-induced symptomatic hyperprolactinaemia in adolescents,” similar results were observed.

However, this study had observed Risperdal side effects in adolescent patients and had been conducted before the drug was officially approved to treat this patient population.

The study showed that three male patients had developed gynecomastia, while two female patients developed galactorrhea, or the sudden and excessive development of breast milk.

Overall, the researchers suggested that there could be serious consequences for younger patients taking Risperdal, advising physicians to consider alternative options.

Overview of Risperdal Gynecomastia Complications

Ignoring these studies proved to be a fatal error as a number of young boys, had reported developing the peculiar condition of male-breast growth.

Gynecomastia is a condition that occurs when there is a severe hormonal imbalance inside the boy’s body, which results in unnatural breast growth. There are a number of theories as to why gynecomastia occurs after using Risperdal, with the main theory revolving around Risperdal’s treatment mechanism.

As mentioned before, the drug works by managing dopamine, which is manufactured in the patient’s pancreas, the body’s headquarters for all the major hormones, including prolactin.

Prolactin is the hormone primarily responsible for breast development in young girls, and is naturally produced in small amounts in young boys. Scientists hypothesize that because Risperdal interferes with the body’s natural prolactin production by affecting the pancreas, it causes an upsurge in prolactin.

This is a devastating side effect, as the excess breast tissue will most likely have to be removed surgically, and will leave the young boys with severe emotional trauma. This side effect has caused public outcry amongst Risperdal patients, who suffered male-breast growth.

Jansen and Bayer are now facing a number of Risperdal lawsuits from patients, who allege that the companies concealed this information to protect the market value of the product.