Study Finds Correlation Between Risperdal & Gynecomastia

Adding to a growing body of research linking Risperdal and gynecomastia in young boys and men, a recent study published in the Journal of Child and Adolescent Psychopharmacology has revealed a correlation between the two following an intense look at over 15,000 cases.

The study, which was published online ahead of print on August 19, 2015, studied a cohort of males between the ages of 15 and 25 years of age. The group was selected from a database known as the IMS Lifelink, which is described as the most comprehensive collection of data relating to patient experience and outcomes across nearly 150 million de-identified health plan claims.

For purposes of the study, researchers selected 401,924 cases to review and implemented ten separate controls within the study. From there, the controls were matched to cases based on age, follow-up, and calendar times (i.e., cases and controls had matching follow-up and cohort entry dates).

After reviewing the 401,924 cases, there emerged a total of 1,556 cases of gynecomastia – a condition marked by the development of breast tissue in men. After further reviewing these cases, researchers discovered that men belonging to this group were four times more likely to have been prescribed Risperdal or its generic equivalent known as risperidone. Researchers further stratified the data collected to determine that children and adolescents 18 years of age or younger who were prescribed Risperdal were five times more likely to develop gynecomastia than non-users.

What is Risperdal?

Risperdal is the brand name of the drug known as risperidone, and is manufactured by Janssen Pharmaceuticals. The drug was approved in 2002 by the Food and Drug Administration for the treatment of schizophrenia, and is indicated for use in patients aged 13 and older. In 2003, it was approved as a short-term treatment for acute mania associated with Bi-polar Disorder in adults and children aged 10-17. Thereafter, approval was further widened to treat symptoms of autism in children aged 5-17, including aggression, self-injury, temper tantrums and unpredictable mood swings.

The drug is not without controversy, however, and it requires a black box warning label concerning elderly patients suffering from dementia. According to reports, use of Risperdal in this population could lead to the increased risk of death, and the drug is not currently approved for use to treat dementia-related symptoms.

Risperdal and gynecomastia

In addition to problems associated with elderly Risperdal use, use of the drug by male children, adolescents and adults has been increasingly linked to the onset of male breast tissue growth. In some cases, men experienced the growth of breasts so large it became necessary to surgically remove the tissue. In other cases, men developed breast cancer requiring chemotherapy and radiation treatments to correct.

Notwithstanding the increased adverse reports and empirical data showing a positive correlation between male breast growth and Risperdal use, patients have alleged in a series of lawsuits that they were not warned by their healthcare provider or the drug manufacturer as to this particular risk of harm. Accordingly, Risperdal lawsuits have emerged nationwide by patients seeking adequate and fair compensation for both medical expenses and emotional turmoil associated with the development of gynecomastia.

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