As if being an adolescent with mental illness weren’t difficult enough, one psychiatric medication sometimes prescribed to boys and young men puts them at risk for male breast growth.

What is Risperdal?

Risperdal, an antipsychotic medication that’s been on the market since December 1993, has been the subject lately of many civil lawsuits and enforcement efforts by federal and state officials. Its currently FDA-approved as a treatment for schizophrenia, manic episodes associated with bipolar disorder, and irritability associated with autistic disorder. Risperdal was once Johnson & Johnson’s biggest moneymaker. Worldwide sales of Risperdal from 2003 to 2010 totaled over $24 billion. Sales then decreased once J&J lost patent protection, allowing generics to enter the market.

Part of Risperdal’s mechanism of action is to operate on dopamine D2 receptors. That action also increases levels of prolactin, a hormone that’s associated with development of breast tissue and stimulation of milk production. For male patients, the result can be the abnormal male breast growth or gynecomastia.

Risperdal Lawsuits

Hundreds of former Risperdal patients who later developed gynecomastia have sued J&J and its subsidiary Janssen Pharmaceuticals. There are over 1,000 such claims pending in Pennsylvania state court alone. One autistic man says he grew breasts up to size 46DD while on Risperdal.

Generally, these plaintiffs allege the manufacturers knew about the risk of Risperdal gynecomastia, but purposely withheld information about that risk from patients and their doctors. Former FDA commissioner David Kessler offered expert testimony showing Janssen was indeed aware of the risks.

Kessler testified that in a 2001 clinical trial, funded by Janssen, 3.8 percent of boys who took Risperdal developed breasts. The researchers concluded that this abnormal breast development was “probably or very likely” caused by Risperdal. Despite these findings, J&J did not add a warning about Risperdal gynecomastia until five years later.

Both Janssen and J&J deny any impropriety on their part. Attorneys for the defendants say the plaintiffs don’t have the science to back up their claims. Still, the company has been settling Risperdal lawsuits one-by-one since 2012

Risperdal Marketing Practices Questioned

In addition to Risperdal lawsuits, J&J has had to respond to a massive wave of enforcement action by the federal government and several states attorney generals. In 2013, an investigation into many of J&J’s business practices culminated in a settlement agreement worth $2.2 billion in criminal and civil penalties, one of the largest penalties ever paid for health care fraud.

Part of that settlement addressed allegations that J&J unlawfully marketed Risperdal for use in children at a time when the FDA had approved the drug only for use in adults. For its first thirteen years on the market, Risperdal was only approved for use in adults; the FDA did not approve it for use in children until 2006. Former commissioner Kessler testified that during that period, J&J engaged in promotional efforts directed at doctors encouraging them to prescribe Risperdal for use in children.

While doctors legally have discretion to prescribe a medication for a use other than those approved by the FDA – so-called “off-label” use – the manufacturers of that medication are allowed to market the medication only for FDA-approved uses. Marketing for any unapproved use is known as “misbranding.”