Risperdal, which had sales of $4.9 billion last year, is the focus of a growing debate over whether antipsychotic drugs are overused in children.

At the center of the controversy is Johnson & Johnson’s funding of an academic center in 2002 for the purpose of conducting “rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children.”

According to a Wall Street Journal report, Johnson & Johnson was directly involved in funding a research clinic, aimed at testing Risperdal side effects on children suffering from bipolar disorder and autism.

About Risperdal

Risperdal is an atypical antipsychotic used to treat adolescents and adults with schizophrenia and bipolar disorder as well as irritability associated with autistic disorder in children ages 6 to 16. It is linked to the side effect of gynecomastia, or male breast growth.

Risperdal is also being used more and more as a treatment for ADHD, even though this is an off-label use that has not been approved by the U.S. Food & Drug Administration (FDA). While Risperdal has been on the market since 1996, it wasn’t until 2006 that the FDA approved the use of Risperdal in children.

The active ingredient in Risperdal is risperidone, which works by affecting the levels of dopamine and serotonin in the brain. These neurotransmitters are known to affect mood and behavior.

Concern over Risperdal side effects in young children, particularly young boys, has grown in recent years not only in the medical community but with the FDA as well.

Many physicians voiced their concerns over Risperdal side effects in an FDA meeting in November 2008, calling for stronger warning labels specifically for Risperdal gynecomastia or the growth of Risperdal breasts.

Troubling Risperdal Side Effects

While there are numerous commonly reported Risperdal side effects, there are also serious side effects that require medical attention. Perhaps the most troubling of Risperdal side effects is Risperdal gynecomastia or male breast growth.

Gynecomastia is a condition that causes male patients to develop breasts. Mental health professionals report that male breasts can have a significantly harmful mental and emotional effect on boys and young men, often causing shame and humiliation and deep self-hatred.

The emotional scars may last well past any surgical remedies as boys may be severely taunted by their peers and suffer emotional trauma when trying to engage in normal activities.

Many doctors have reportedly recommended that adolescent males who suffer from Risperdal gynecomastia undergo surgery. Mild cases can be resolved with liposuction, while more severe cases require a mastectomy.

A number of studies have indicated that use of Risperdal may cause male breast development. In 2006, one such study published in the Journal of Clinical Psychopharmacology found that the use of risperidone in children was associated with excessive levels of the hormone prolactin, which is tied to female breast development and lactation.

Three years later, research published in the Journal of Child and Adolescent Psychopharmacology revealed that these high levels of prolactin could persist for as many as two years.

J&J Faces Mounting Risperdal Litigation

In 2013, J&J was ordered to pay more than $2.2 billion to resolve a criminal and civil investigation surrounding the drug, one of the largest healthcare fraud penalties ever.

In fact, Risperdal wasn’t approved for any use in minors until as late as 2006, after which it was issued a new label warning—noting the possibility of Risperdal gynecomastia, or Risperdal breasts development.

In addition to claiming the use of Risperdal caused male breast growth, Risperdal lawsuits filed on behalf of children allege that Johnson & Johnson improperly marketed the drug for pediatric use before the FDA cleared it for such purposes.

In fact, Risperdal wasn’t approved for any use in minors until as late as 2006, after which it was issued a new label warning—noting the possibility of Risperdal gynecomastia, or Risperdal breasts development.

Even former FDA commissioner David Kessler testified in court that J&J pushed for doctors through marketing to prescribe the drug of “off-label”—or for uses it wasn’t formally tested and approved—claiming that J&J “knew by 2001 that Risperdal could cause abnormal breast development in boys.”

Allegedly, this is what happened to 20-year-old autistic man Austin P. who grew size 44DD breasts as a result of taking the drug since age eight—and who won $2.5 million in 2015, Austin’s case was the first of 1,200 pending Risperdal cases filed in Philadelphia scheduled to go before a jury.

In June 2015, the drug maker settled yet another Risperdal gynecomastia lawsuit mere hours before opening arguments were slated to begin, in which plaintiff Christopher W. claimed he suffered abnormal breast growth as a result of Risperdal side effects.

However, Johnson & Johnson continues to claim that the so-called “Risperdal breasts” are the result of obesity and puberty.

Filing a Risperdal Side Effects Lawsuit

If you or someone you know has taken Risperdal and has suffered the serious side effect of male breast growth as a result of using this defective drug, a lawsuit against the drug company may be a valid option for you to seek compensation for hospital bills, surgical expenses, mental trauma, loss of income or productivity, pain and suffering and more.