Risperdal and Gynecomastia

The antipsychotic medication Risperdal (risperidone) is primarily used to treat bipolar disorder and schizophrenia. The drug was originally approved by the FDA in 1993 to treat adults with these conditions. However, Risperdal manufacturer Johnson & Johnson also actively promoted their antipsychotic for use in children, despite growing evidence of a link between Risperdal and gynecomastia.

In 2007, the FDA extended Risperdal approval to children and adolescents with mental disorders, although the new approval came with warnings about potential side effects. One of the most troublesome side effects associated with the drug is enlargement of male breasts, or gynecomastia. Gynecomastia can also be accompanied by galactorrhea (production of breast milk) in some young men and boys that take the medication.

Risperdal side effects and male breast enlargement

Risperdal works by blocking dopamine effects in the body. Scientists believe that excess dopamine production can lead to disorders like schizophrenia, so blocking the substance may lead to a reduction of symptoms. However, blocking dopamine affects prolactin regulation, which can lead to male breast growth. Children and teens may be more vulnerable to this side effect, since changing hormone levels in their young bodies may place them at higher risk.

According to the FDA warning label, gynecomastia occurs in approximately 2.3% of all patients that take Risperdal. The label also states risk of gynecomastia is higher with Risperdal use than with other antipsychotic medications. For boys that develop this condition after taking risperdone, the results can be emotionally and psychologically devastating.

About gynecomastia

Gynecomastia is characterized by male breast enlargement of one or both breasts. Milk production may or may not accompany the condition. Breast enlargement can vary significantly between patients, with some experiencing a mild amount of growth and others developing breast size comparable to a D-cup in women.

Other symptoms of gynecomastia might include:

• Swelling
• Breast pain
• Nipple discharge
• Tenderness of breast tissue

In addition to the physical symptoms, psychological issues may also develop due to:

• Teasing and rejection
• Humiliation and embarrassment
• Depression and anxiety
• Feelings of isolation, loneliness
• Adjustment disorders
• Tension and restlessness
• Suicidal thoughts

Studies have found that the psychological impact of gynecomastia can be far-reaching. In one study, researchers discovered adolescents suffering from abnormal breast growth had lower ratings of social functioning and self-esteem, as well as lower levels of overall health. The severity of the issues did not appear to be linked to the severity of the condition.

Treatment for gynecomastia

Because gynecomastia as a result of Risperdal use can be permanent, treatment for the condition often requires surgery to reduce the size of the breasts. Procedures used for this purpose include a mastectomy, which involves surgical removal of breast tissue and excess skin. When breast growth is minimal, liposuction may also be an option. Liposuction is a procedure where excess tissue is extracted via a narrow tube called a cannula. Both of these procedures require anesthesia and involve recovery time afterward. In some cases, a combination of the two may be recommended to produce the best possible results.

Because of the risks and recovery time associated with surgery, some patients do not pursue this option. For these individuals, medication may be prescribed off-label to stop the breast growth. However, it will not be able to reverse development of the breast tissue that has already taken place. Individuals suffering from gynecomastia may also need counseling to cope with the embarrassment and other psychological side effects that may accompany the condition.

Risperdal and male breast growth

Numerous studies and reports have shown a direct link between Risperdal use and gynecomastia in male children and adolescents.

The following are some highlights of the published data.

• A study published in ActaPsychiatrica Scandinavica in 1998 found use of Risperdal led to elevated prolactin levels that can cause enlarged breast growth in males.
• Researchers published a study in the Journal of Clinical Psychopharmacology in 1999 that showed the risk for this condition increased when larger amounts of the drug were taken.
• Scientists conducted a study in 2003 that found the risk for elevated prolactin levels in Risperdal users was as high as 65%. That study was published in Pharmacological Research.
• Researchers at Duke University conducted a study in 2006 that found Risperdal use accounted for 70% of all gynecomastia cases related to use of antipsychotic medication.

Additionally, a 2008 report in the Wall Street Journal indicated Risperdal use can stimulate prolactin production, which is a hormone involved in the lactation process. At the same time, the publication commented on the growing number of product liability lawsuits filed by boys who developed enlarged breasts after taking Risperdal.

Risperdal litigation regarding gynecomastia

Since that Wall Street Journal report, dozens of Risperdal lawsuits have been filed against manufacturer Johnson & Johnson involving gynecomastia. Some of those cases have been settled by the pharmaceutical giant, including one complaint filed by Aaron Banks. Banks alleged he began taking the drug off-label at the age of nine, and eventually had to have surgical removal of his breasts. Now 21, Banks settled with Johnson & Johnson for an undisclosed amount.

Johnson & Johnson has also paid millions in fraud settlements regarding Risperdal, after it was found the company was illegally promoting the drug for off-label purposes. In addition to marketing the drug to children and adolescents for conditions not yet FDA-approved, doctors were encouraged to use the drug to treat dementia in elderly patients despite evidence of deadly risperdone side effects in seniors.

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