A prescription atypical antipsychotic, Risperdal, has been linked to a high risk of male breast development by growing body of medical research studies as well as lawsuits filed against its manufacturer, Johnson & Johnson.
The drug is approved by the US Food & Drug Administration for the following indications and usage:
- Treatment of schizophrenia in adults and adolescents aged 13-17 years
- Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescents aged 10-17 years
- Treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years
While “changes in body weight” is an adverse effect mentioned in the FDA approved prescribing information for Risperdal, there is no mention of male breast development. The occurrence of Risperdal related gynecomastia cannot simply be attributed to weight gain; a number of male adolescents and children taking the drug have even begun to lactate. Breasts as large as 38D have been observed on young men, and in at least one case a double mastectomy was required for the treatment.
These horrifying scenarios are not simply due to the “changed in body weight” included in prescribing information. Something else is going on to produce this male breast development, sometimes referred to as man boob syndrome. Many of these Risperdal victims choose to file a lawsuit against Johnson & Johnson for the financial, physical, and emotional distress resulting from this drug.
Risperdal FDA Black Box Warning
In 2006, the FDA included a Black Box Warning regarding atypical antipsychotics, including Risperdal, and an increased risk of death in patients with dementia-related psychosis. Interestingly, risperidone has not even been approved by the agency for this indication. Dementia, anxiety, and anger management are several of the unapproved uses for Risperdal that Johnson & Johnson has been accused of illegally advertising. In August of 2012, J&J paid around $180 million to settle accusations from over 30 states that it had promoted Risperdal and another drug, Invega, for unapproved indications. The first Risperdal lawsuit claim filed regarding male breast development (known by some as “man boob syndrome”) was settled in 2012.
Risperdal Side Effects
Gynecomastia (medical term for the development of enlarged breasts in males) can exhibit the following symptoms: swollen breasts, tenderness in breast tissue, swelling, discharge from breasts (signs of lactation), and pain. While it sometimes resolves itself, male breast growth may require surgical treatment in some cases for one or both breasts. Most devastating are the emotional ramifications of Risperdal gynecomastia. The growth of female breasts and experience of lactation frequently result in significant emotional trauma when experience by males, especially adolescent males and male children.
Other Serious Risperdal side effects include:
- Tardive dyskinesia
- Cerebrovascular events in elderly patients
- Neuroleptic Malignant Syndrome
- Hyperglycemia and diabetes mellitus
- Leukopenia, Neutropenia, and Agranulocytosis
- Orthostatic hypotension
- Potential for cognitive and motor impairment
- Disruption of body temperature regulation
- Increased sensitivity in patients with Parkinson’s disease or dementia with Lewy bodies
- Antiemetic Effect
Commonly reported adverse effects from Risperdal include:
- Increased Appetite
- Abdominal pain
- Upper Respiratory Tract Infections
- Dry Mouth
- Increased saliva production
- Urinary incontinence
Experiencing Male Breast Development? File a Risperdal Lawsuit
As listed above, the drug Risperdal includes a troubling list of adverse health effects, including the development of breasts in males. If your or a loved one is the victim of Risperdal gynecomastia, please contact the product liability lawyers at the Willis Law Firm today. We are available to evaluate your potential Risperdal lawsuit free of charge or further obligation; in fact, you will not be responsible for any attorney or legal fees unless a recovery is obtained in your favor. Don’t delay; let us help you stand up against this harmful drug today.
Free Risperdal Lawsuit Evaluation – Call Nationwide 1-800-883-9858