The psychiatric drug Risperdal has been at the focus of millions of dollars worth of civil litigation and regulatory enforcement efforts.

First approved by the FDA in 19993, Risperdal is now approved as a treatment for schizophrenia, the manic episodes associated with bipolar disorder, and irritability associated with autistic disorder.

It’s also seen some off-label use lately as a treatment for attention-deficit hyperactivity disorder, or ADHD.

Risperdal is one of a group of drugs known as atypical antipsychotics.

These drugs generally operate on two neurotransmitters, serotonin and dopamine, in a way that helps control the symptoms of certain psychiatric conditions.

Side Effects of Risperdal

Like most other drugs, Risperdal is not without its side effects. Some of the more common side effects of Risperdal include:

• mood side effects like anxiety or agitation
• difficulty concentrating
• tics, twitching, trembling or shaking
• problems with voluntary movement, such as a shuffling walk, loss of balance, or an inability to move the eyes
• itching or skin rashes
• muscle spasms in the face, neck or back

Dealing with Risperdal Gynecomastia

One of the rarer but more notorious side effects of Risperdal is gynecomastia, the abnormal development of breast tissue in males.

Gynecomastia associated with Risperdal treatment has been the subject of a number of Risperdal lawsuits, some of which have resulted in large damage awards for the plaintiffs.

Gyncomastia could result from Risperdal treatment because of the way the drug operates on the neurotransmitter dopamine.

By inhibiting the action of dopamine, Risperdal may cause the pituitary gland to produce and release more of the hormone prolactin.

One study found that over 90 percent of patients treated with Risperdal experienced  elevated prolactin levels at some point during their treatment.

This effect can continue throughout the period of treatment and sometimes persists after the drug is discontinued.

Prolactin normally stimulates growth of breast tissue and production of milk in women who are pregnant or breastfeeding. It can have the same effect in males whose prolactin levels are artificially stimulated, causing clinical gynecomastia.

This condition can affect men of any age, and it can cause them to grow breasts as large as any woman’s. Sometimes it affects one breast more than another, or it may affect one breast and not the other at all.

In most cases, gynecomastia resolves on its own once Risperdal or whatever other drug may be causing it is discontinued.

But some patients aren’t that lucky. Gynecomastia that persists after the cause is removed may need to be treated with male breast reduction surgery.

Risperdal Litigation

Patients who have taken drug manufacturer Johnson & Johnson to court over side effects of Risperdal have met with some success.

The company settled many of the first few Risperdal lawsuits out of court, in settlement agreements that kept the dollar amounts confidential.

Not all plaintiffs have met with success, but some cases that proceeded to trial have ended in significant awards for the plaintiffs.

The first plaintiff to win a Risperdal trial was awarded a $2.5 million judgment against J&J. Another plaintiff won $1.75 million judgment after the jury found J&J had failed to adequately warn him about the side effects of Risperdal.