Risperdal is one of the most popular antipsychotics in the United States, but also the source of controversy over gynecomastia, a side effect of the drug involving male breast growth.

The Risperdal side effect is caused by an extreme imbalance of hormones, particularly prolactin. This hormone is primarily responsible for breast development in young girls, and is a naturally manufactured in small amounts in young boys. However, Risperdal causes an influx of prolactin production in the pancreas, which can lead to male breast growth in young boys.

Risperdal gynecomastia has been primarily reported in young boys who were prescribed the antipsychotic for schizophrenia or bipolar disorder. Many boys who grow the breasts have had to resort to surgically removing the excess tissue, and have reported suffering from bullying and emotional distress.

The severity of the condition varies between patients, the most extreme cases have grown over 38Ds cups and produce milk. Despite the severity of this condition, gynecomastia is not mentioned on Risperdal warning label, leading to numerous product-liability lawsuits.

Risperdal is manufactured and produced as a joint effort between Bayer Pharmaceuticals and Johnson & Johnson subsidiary Jansen Pharmaceuticals. It was approved by the FDA in 1993 to be a treatment option for adult patients suffering from either schizophrenia and bipolar disorder.

It was approved to treat children in 2006, after the pharmaceutical companies found that it was widely used for pediatric patients. However, Risperdal allegedly was illegally marketed for use by children before its approval.

Overview of Risperdal Gynecomastia Concern

According to court records, nearly 20% of Risperdal prescriptions had been written for pediatric and adolescent patients in the early 2000s. By the time Risperdal was approved to treat children, the drug’s label had been updated to note that gynecomastia occurred in 2.3% of pediatric patients.

The previous Risperdal label described the condition as rare, but did not mention the pediatric element. Later studies and injury reports indicated otherwise, as thousands of young boys reported developing breasts soon after taking Risperdal, with many of them complaining that the breast tissue stayed even after discontinuing the medication.

The association between Risperdal and gynecomastia first came to the attention of medical professionals in 1999, when the journal Psychopharmacology published a study showing a clear correlation between Risperdal and gynecomastia when being used with Prozac.

In 2006, another study was published in the Journal of Clinical Pyschopharmacology showed that Risperdal had significantly increased prolactin levels in adolescent patients. Several other studies found the same results, which helped fuel the numerous lawsuits filed against Bayer and Jansen.

The first Risperdal lawsuit that was part of a Risperdal mass litigation went to trial in Philadelphia in February, with the jury awarding the plaintiff $2.5 million. The trial took a month, with jurors agreeing that the companies did not adequately warn the boy’s parents of the risks of gynecomastia.

According to the lawsuit, the boy started taking Risperdal in 2002 at when he was seven, and used the drug for five years. The lawsuit alleged that Jansen and Bayer deliberately concealed evidence of Risperdal gynecomastia.

This trial was also significant because former FDA commissioner David Kessler testified in the trial, stating that he believed that companies tampered with clinical data to show a minimal Risperdal gynecomatia risk. About 130 Risperdal gynecomastia lawsuits are pending.