Concerns over the adverse side effects of Risperdal have led to billions of dollars in penalties for the drug’s manufacturers.

Risperdal is a psychiatric drug originally developed as a treatment for the symptoms of schizophrenia. It’s also known by the generic name risperidone.

Today, Risperdal is approved by the FDA to treat schizophrenia, bipolar disorder, and symptoms of autism spectrum disorder. Physicians sometimes prescribe it for “off-label” use as a treatment for anxiety, depression, sleep difficulties, or ADHD.

When it was first introduced to the market in 1993, Risperdal had not yet been approved for use in younger patients.

But that apparently didn’t stop manufacturer Janssen Pharmaceuticals from marketing Risperdal for use in children, according to allegations raised following a joint investigation by federal and state authorities.

That investigation culminated in a $2.2 billion settlement between Janssen and the U.S. Department of Justice.

Among the many allegations addressed in the settlement, Janssen and its parent company Johnson & Johnson were accused of improperly marketing Risperdal for use in child patients from 1993 to 2004, at a time when the FDA had approved Risperdal only for use in adults.

Adverse Side Effects of Risperdal

Other investigations and litigation by several state authorities led to many other multi-million dollar penalties against Janssen.

An action by the attorney general of Kentucky brought in May 2012 addressed one of the more controversial adverse side effects of Risperdal. The AG accused J&J of concealing evidence that Risperdal could lead to abnormal development of breast tissue in males, a condition known as gynecomastia.

Scientists believe Risperdal’s effect on the way the brain processes dopamine could be what leads to gynecomastia.

Risperdal works in part by blocking the action of dopamine in the brain. While that action may be what helps keep emotional and behavioral symptoms under control, the reduction in dopamine activity may also stimulate increased production of the hormone prolactin.

Prolactin is normally present in smaller amounts. In pregnant and nursing women, prolactin levels increase to stimulate development of breast tissue and production of breast milk.

When prolactin levels in men are artificially inflated, they can have the same physiological effects. Male patients who develop gynecomastia can grow breasts as large as any woman’s. Some may also produce milk and nipple discharge known as galactorrhea.

These adverse side effects of Risperdal can affect patients of any age, but they can be particularly troublesome for the adolescent boys who are often prescribed Risperdal. Boys at that age can be especially vulnerable to teasing and bullying from their peers.

Litigation Over Risperdal Gyencomastia

Cases of Risperdal gynecomastia have lead to a slew of civil litigation against the drug’s manufacturers.

Plaintiffs in several Risperdal lawsuits claim that Janssen and J&J failed to properly warn them about the adverse side effects of Risperdal. They claim the companies had no business promoting Risperdal for use in young children before it had been approved for use in such patients.

Cases that have gone to trial have yielded substantial jury awards. Many other cases are still waiting in the wings.