In November 2013, drug company Janssen Pharmaceuticals of New Jersey pleaded guilty to misbranding their drug Risperdal. As a part of a plea agreement, the company agreed to pay $1.67 billion in criminal fines and civil settlements. Janssen Pharmaceuticals Inc. is a daughter company of pharmacological behemoth Johnson & Johnson. Even as this issue moves towards resolution, reports of breast growth in males presents new challenges for the drug’s manufacturers.

According to a press release by the U.S. Food and Drug Administration (FDA), the U.S. District Court for the Eastern District of Pennsylvania worked out the agreement. The controversy surrounded Janssen marketing the drug for disorders and conditions beyond its approval. In the early 2000s, the FDA approved Risperdal for treating schizophrenia and bipolar disorder. However, the company allegedly marketed the drug for other conditions, including dementia.

When a drug like Risperdal is approved, it is thoroughly tested and efficacy as a part of the approval process. But in the case of dementia, the drug was not fully tested in the afflicted population, and concerns emerged that the drug could be linked to an increased risk of stroke in non-schizophrenic dementia patients.

On the heels of these Risperdal settlements, reports have come to light that the drug may cause an increased risk of gynecomastia–the growth of breasts in males. The prescribing information includes references to this possibility. The prescribing information states that the drug is linked to increases in a hormone called prolactin. In healthy females, prolactin is the hormone that causes breasts to grow. Unfortunately, it can have the same effect on males when the hormone is produced in response to drugs.

Risperdal’s prescribing information includes references to reports of gynecomastia in males taking the drug, but numerous Risperdal lawsuits allege that patients were not adequately warned about how prevalent this risk is.

Risperdal Lawsuits Cite Pain, Trauma of Male Breast Growth

Gynecomastia is a concerning medical condition. While not usually dangerous, it can be very emotionally challenging. Males who grow breasts can find the experience humiliating and embarrassing. Patients may not realize why it is happening, and may not make the connection that Risperdal is the cause of their condition.

To reverse the effects of the gynecomastia, patients may require surgery. Since many patients who take Risperdal have preexisting psychiatric disorders, it may be very difficult for them to trust others enough to seek help. Additionally, this side effect is most common in younger males taking Risperdal, including preteens and teenagers.

If you’re a male who took Risperdal between the ages of 10 and 18, and went on to experience gynecomastia, you have almost certainly been through a trying ordeal. The disorder is traumatic, and often occurs during the already-stressful teen years. When facing this condition, many males may feel embarrassed and depressed. But you need to remember that regardless of the challenges you’re facing, you have rights, and there are steps that you can take to regain a measure of control over the situation.