Risperdal, an antipsychotic given to adults for schizophrenia and bipolar disorder and to children for treating autism-related irritability, has been associated with breast development in men, a condition known as gynecomastia. A 2006 study in the Journal of Clinical Psychopharmacology confirmed a link, but the research primarily focused on adolescents. As a result, the study recommended the drug not be given to adolescents and children.

But what about older men? A study published in the same journal in August 2014 reveals that Risperdal may have a similar effect on middle-aged males, with 69 percent likely to develop larger breasts while taking the drug. Cases confirming this relationship have been reported to the FDA.

Researchers behind this study aimed to determine if Risperdal is more likely to cause gynecomastia in this age group than other antipsychotics, like Seroquel and Zyprexa. 8,250 men taking Risperdal and 82,850 control subjects were observed, with researchers eventually concluding that those taking Risperdal were 40-percent more likely to develop breasts than if they took another antipsychotic.

The reason, however, isn’t clear, but researchers think that Risperdal’s higher prolactin levels could create hormonal changes in men that lead to breast tissue development.

Confirming these findings, an article published in Lawyers & Settlements revealed that Risperdal, given to veterans for off-label anxiety treatment, may actually exacerbate the condition, all while still causing gynecomastia, weight gain, and diabetes.

The FDA initially approved Risperdal in 1993, and by 2003, it was recommended for schizophrenia treatment in adults. 2006 saw the organization recommend it for children with autism and those under 16 with bipolar disorder.

Aside from gynecomastia, Risperdal is associated with several serious side effects, including neuroleptic malignant syndrome (NMS), tardive dyskinesia, increased risk of death in elderly patients, metabolic syndrome, pancreatitis, Hyperprolactinemia, weight gain, stroke risks, and diabetes. In fact, patients’ diabetes risk is said to increase 50 percent when on the drug.

So far, 463 claims have been consolidated into multi-district litigation in New Jersey, with hundreds more pending at the state level. Plaintiffs allege that manufacturer Johnson & Johnson failed to adequately warn about side effects and provided kickbacks to Omnicare. As well, plaintiffs have sought compensation for psychological trauma and surgery to remove the excess breast tissue, including liposuction and mastectomy procedures.