Risperdal, an atypical antipsychotic made by Janssen Pharmaceuticals, is currently approved by the FDA as a treatment for schizophrenia.

Depending on the patient’s age, Risperdal may also be approved to treat bipolar disorder and autism spectrum disorders.

Like other antipsychotics, Risperdal has been associated with an increased incidence of breast tissue development in males. This abnormal growth of male breast tissue is known clinically as gynecomastia.

The Science Behind Risperdal Male Breast Growth

Scientists believe that Risperdal male breast growth is linked to an alteration of natural hormone levels.

Antipsychotics like Risperdal can cause the pituitary gland to release an excess of the hormone prolactin. One study found that as many as 90 percent of Risperdal patients may experience elevated prolactin levels at some point during their treatment.

Normally, prolactin stimulates breast growth development in women. The same effect can happen in men whose prolactin levels have been artificially elevated.

Generally, the condition is not considered a threat to physical health. Some patients report pain or tenderness associated with the new breast tissue.

The psychological effects, however, can be more problematic, especially for younger patients who may be more susceptible to teasing and bullying from their peers.

Less severe cases of Risperdal male breast growth may resolve by themselves after the patient stops taking Risperdal.

Other cases may be more stubborn. Some patients have had to undergo male breast reduction surgery to get rid of the excess tissue.

J&J Faces Federal, State Enforcement Actions

Janssen’s marketing of Risperdal has been implicated in a number of enforcement actions by the federal government and several states’ attorneys general, to the tune of billions of dollars in penalties.

In November 2013, the U.S. Department of Justice announced a $2.2 billion settlement with Johnson & Johnson to resolve criminal charges and civil allegations over how it marketed several of its pharmaceutical products.

Among those allegations, J&J was accused of misbranding Risperdal.

Among many other allegations, the government claimed that from 1999 through 2005, Janssen promoted Risperdal for use in children. At the time, J&J and Janssen allegedly knew there was a risk of Risperdal male breast growth in children.

Yet the company allegedly made a point of growing and protecting the drug’s market share among young patients.

The DOJ alleged that Janssen instructed its sales representatives to promote Risperdal directly to child psychiatrists and facilities that treat young psychiatric patients, telling them that Risperdal was a safe and effective treatment for several different childhood psychiatric disorders like ADHD, autism, oppositional defiant disorder, and obsessive-compulsive disorder.

The DOJ noted that Risperdal was not FDA-approved for use in children until 2006, and that the FDA had repeatedly warned Janssen against promoting the drug for use in children.

Several state governments have also pursued their own enforcement actions against J&J over similar allegations.

An investigation by Montana’s attorney general resulted in a $5.9 million settlement over allegations that J&J had used illegal, unfair and deceptive practices in its marketing of Risperdal.

Enforcement actions in other states such as Louisiana, Arkansas and South Carolina have also ended in penalties against the company.