Risperdal and Gynecomastia

The use of Risperdal (risperidone) in young men has been linked to a condition called gynecomastia, or the enlargement of male breast tissue. Although gynecomastia is non-cancerous, the growth of male breasts can cause severe embarrassment and lasting psycho-social harm. Surgery may be required to correct the condition. In September 2012, Johnson & Johnson settled the first Risperdal gynecomastia lawsuit. 

Risperdal and Gynecomastia

Risperdal (risperidone) is a medication used to treat severe psychiatric disorders, including schizophrenia, acute mania, irritability associated with autistic disorders, and more. Risperdal is also sometimes prescribed with antidepressant medications to treat severe depression.

Risperdal can significantly increase levels of prolactin, a hormone that the body normally releases to stimulate breast growth and milk production. In females, Risperdal may cause spontaneous production of milk. In males, Risperdal may cause enlargement of male breast tissue — a condition called gynecomastia.

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Studies Linking Risperdal to Gynecomastia in Boys

This study, published in 1999 in Psychopharmacology, was one of the first studies to link Risperdal to gynecomastia, when combined with Prozac (fluoxetine).

This study, published in 2009 in the Journal of Child and Adolescent Psychopharmacology found “Persistent elevation of prolactin for periods up to 2 years has been documented in maintenance treatment with risperidone.”

This study, published in 2006 in the Journal of Clinical Psychopharmacology, researchers warned:

“Risperidone administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia and/or galactorrhea. Given that the long-term effects of antipsychotic drug-induced hyperprolactinemia are not well documented, especially regarding osteopenia, infertility, growth, and pubertal delay, risperidone should be administered with caution to children and adolescents.”

What is Gynecomastia?

Gynecomastia is the growth or enlargement of male breast tissue caused by a hormonal imbalance. Although the tissue is benign (non-cancerous), it can be devastating for a man’s social health, self-esteem, and emotional well-being — especially when it affects young boys or teenagers.

Surgery is often necessary to cure gynecomastia. Liposuction procedures may be effective for mild or moderate cases. However, severe cases of gynecomastia usually require breast-reduction surgery, or a complete mastectomy — removing the breast tissue and the excess skin of the breast.

Risperdal Side Effects

Risperdal has been linked to many severe side effects, including:

  • Gynecomastia (growth of male breasts, which may be painful or tender)
  • Galactorrhea (production of milk from breasts)
  • Diabetes, high blood sugar (hyperglycemia)
  • Bone loss (demineralization)
  • Sexual dysfunction
  • Pituitary tumors
  • Tardive dyskinesia (involuntary movement disorder)
  • Weight gain, which may be severe
  • Neuroleptic Malignant Syndrome (NMS)
  • Heart problems, heart attack, irregular heart rhythm
  • Suicide
  • Pancreatitis
  • Increased risk of death among elderly people with dementia
  • And more

J&J Settles Lawsuit Alleging Injury From Antipsychotic

Updated September 10, 2012, 4:29 p.m. ET

By PETER LOFTUS

Johnson & Johnson JNJ -0.30% agreed to a last-minute settlement of a lawsuit claiming that a boy’s use of its antipsychotic drug Risperdal caused abnormal breast growth.

The settlement—whose terms were confidential—averted a civil trial scheduled to begin Monday in which plaintiffs’ lawyers intended to summon J&J Chief Executive Alex Gorsky as a witness. Mr. Gorsky previously held leadership roles at the J&J division responsible for marketing Risperdal during the period when the boy’s alleged injury occurred.

Robert C. Hilliard, an attorney for the plaintiff, told a judge in the Philadelphia Court of Common Pleas Monday “this case has reached a final resolution.” He said the settlement amount was confidential.

J&J confirmed it reached a resolution of the case but didn’t disclose terms in a statement.

J&J disclosed in its annual report in February that it was facing about 420 product-liability claims and lawsuits related to use of Risperdal. The drug, which treats schizophrenia, bipolar mania and irritability associated with autism, has been linked to increased risk for various adverse events including weight gain and elevated blood sugar.

The lawsuit at the center of Monday’s settlement alleged that a boy developed gynecomastia, or abnormal breast development in males, as a result of Risperdal use between 1999 and 2004, said his attorney, Stephen A. Sheller. The boy, now an adult, had his breasts removed surgically, Mr. Sheller said.

The lawsuit alleged that J&J didn’t sufficiently warn of the risk of gynecomastia.