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The Drug

Risperdal (Risperidone), manufactured by the Johnson & Johnson subsidiary Janssen, received FDA approval for the treatment of schizophrenia in 1993.  Indications (uses) were expanded to include adults with bipolar disorder in 2003; children with autism in 2006; and schizophrenia in youths 13-17 in 2007. Risperdal is classified as an ‘atypical,’ or second generation, antipsychotic drug (though this classification is debatable), because it triggers fewer motor control disabilities than traditional antipsychotics.

The Controversy

Part of Risperdal’s mechanism of action is its antagonistic effect at dopaminergic receptors.  As a consequence, the hormone prolactin can exhibit dysregulation, ultimately producing estrogenic effects such as gynecomastia (breast tissue development) and galactorrhea (milk production) in males.  Treatment may require plastic surgery or liposuction, and the problem can often cause psychological damage, especially in young men.

The link between Risperdal and gynecomastia was first published in a 1999 study involving concomitant use of Risperdal and the SSRI Prozac.[i]  In 2006, another study noted a significant increase in Prolactin levels for adolescents exposed to Prolactin.[ii]  In 2009, researchers published observations that the elevation in Prolactin levels could persist for two years.[iii]  In 2012, a review of antipsychotic medications found a higher rate of gynecomastia associated with Risperdal than any other treatment, and found that younger patients may be more susceptible.[iv]

Risperdal has also garnered the Government’s attention at both federal and state levels, due to Johnson & Johnson’s improper marketing and promotion of the drug to older adults suffering from dementia, and children with developmental disabilities.  As a result, Johnson & Johnson agreed to pay several states and the federal government some $2.2 billion in criminal and civil fines, one of the largest pharmaceutical-related settlements in United States history.[v]


Symptoms of gynecomastia and galactorrhea include:

  • Pain

  • Tenderness

  • Swelling

  • Nipple discharge

We Want to Help

If you or a loved one has experienced gynecomastia or galactorrhea and have used Risperdal in the past, please contact Freese & Goss today. Attorneys are available by phone, e-mail, or by clicking here.

[i] DL Kleinberg et al., Prolactin Levels and Adverse Events in Patients Treated with Risperidone, 19(1) J. Clin. Psychopharmacol. 57-61 (1999).

[ii] R. Knegtering et al., Predominant Role of the 9-Hydroxy Metabolite of Risperidone in Elevating Blood Prolactin Levels, 162(5) Am. J. Psychiatry 1010-2 (2005).

[iii] Y. Roke et al., Antipsychotic Medications in Children and Adolescents: A Descriptive Review of the Effects on Prolactin Level and Associated Side Effects, 19(4) J. Child Adolesc. Psychopharmacol. 403-14 (2009).

[iv] J. Cookson et al., Prolactin, Hyperprolactinaemia and Antipsychotic Treatment: A Review and Lessons for Treatment of Early Psychosis, 26(5 Suppl) J. Psychopharmacol 42-51 (2012).

[v] Katie Thomas, J&J to Pay $2.2 Billion in Risperdal Settlement, The New York Times, November 4, 2013.

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