Risperdal is a powerful antipsychotic medication that is prescribed to adult and pediatric patients, to treat extreme mental disorders. Unfortunately, this drug has allegedly been causing devastating side effects to occur in young boys.

Risperdal is manufactured by Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals, and was originally approved in 1993. However, it was not approved for pediatric use until 2006, which is troubling considering that the manufacturing companies are accused of marketing it for such reasons, since its release. While it is not illegal for doctors to prescribe medications for off-label purposes, it is illegal for drug companies to advertise them for such.

This illegal marketing led to Johnson & Johnson paying millions to the Department of Justice, to settle the illegal marketing claims against it. While the companies have admitted to no wrongdoing, Janssen still continues to face Risperdal lawsuits from young boys and their families, who suffered the devasting Risperdal side effect, gynecomastia. Gynecomastia is the abnormal development of breasts in young boys, which is typically caused from a hormone imbalance.

It is important to note that even before Risperdal was approved to treat children, the side effects of pediatric Risperdal use were widely unknown. As mentioned before, Risperdal is prescribed to treat certain psychotic conditions like schizophrenia, bipolar disorder, and certain types of autism in children; it can also be used to treat attention deficit hyperactivity disorder (ADHD), anxiety, insomnia and depression. Risperdal is considered an atypical antipsychotic medication, because it works by not only channeling a specific serotonin channel, bit also the brain chemical dopamine, which is responsible for the brain’s pleasure and rewards sensors.

Risperdal’s treatment mechanism is vastly different from traditional antipsychotics, which aim to stabilize the entire brain. Medical experts argue that atypical antipsychotics may be more efficient than first-line treatments, because they have less severe symptoms. According to the FDA, Risperdal is the first FDA approved atypical antipsychotic drug to treat bipolar disorder and schizophrenia for both adult and pediatric patients. However, this prestige does not discount the numerous injury reports submitted by former Risperdal patients.

Overview of Risperdal Pediatric Complications

In a previous study conducted by Janssen Pharmaceuticals, the FDA requested that the company observe Risperdal use in pediatric and adolescent patients with schizophrenia and bipolar disorder. This request was made because the FDA became concerned about how often Risperdal was prescribed to treat pediatric patients with these conditions, despite being off-label purposes. This Risperdal study was conducted in two trials, each lasting six to eight weeks; the patient groups were either prescribed Risperdal or a placebo. The study found that the Risperdal patients generally suffered fewer side effects, while being highly efficient in controlling hallucinations, delusional thinking, and other schizophrenic or bipolar symptoms.

Interestingly enough, the most notable side effect Janssen observed during the study was weight gain; gynecomastia was not even recorded. However, gynecomastia has been mentioned numerous times in injury reports and other scientific inquiries, suggesting that there may be higher risks than what had appeared in the Janssen study. In fact, hundreds of boys have reported developing breasts after taking Risperdal, often having to undergo removal surgery to rid the excess tissue.

As mentioned earlier, gynecomastia is caused by a hormonal imbalance in adolescent boys, but experts are unsure as to why Risperdal may be causing this. One central theory experts agree on is that Risperdal is a natural prolactin enhancer, which can lead to devastating side effects during the patient’s puberty stage. Prolactin is the hormone responsible for breast development in adolescent girls and controls the sex drive in boys, which is produced by the body’s pituitary gland. Also mentioned before, Risperdal works by blocking the brain’s dopamine channel, which is also manufactured in the pituitary gland.

Experts believe that by interfering with the natural dopamine channel, the hormonal levels of prolactin become so high that the patient develops the condition known as hyperprolactinemia. Hyperprolactinemia is an overabundance of prolactin the body, which can lead to conditions like gynecomastia. This condition occurs more often in Risperdal patients than any other antipsychotic.