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Drug Company Faces Claims Risperdal Caused Breast Growth in Young Males

If you or someone you love took Risperdal and have developed gynecomastia, you may be able to seek financial compensation by filing a product defect claim. According to a fact sheet from the Mayo Clinic, gynecomastia is a condition in which breast tissue swells in boys or men, resulting in enlarged breasts.

Recent articles in Forbes Magazine and The Wall Street Journal reported that Janssen Pharmaceuticals, Inc., which is a Johnson & Johnson company, has been accused of a failure to warn about the side effect. In this product defect allegation, the articles suggest that the drug maker failed to alert healthcare providers and consumers that risperidone, the generic name for the brand-name drug Risperdal, may lead young males to develop breasts.

Understanding Risperdal and Its Uses

What kind of drug is Risperdal, and why are young male patients taking it? According to the prescribing information sheet provided by the FDA, Risperdal is “an atypical antipsychotic agent” that can be prescribed for the following kinds of patients and conditions:

  • Treatment of schizophrenia in adolescents between the ages of 13-17 and adults aged 18 and older.
  • Short-term treatment of manic episodes linked to Bipolar I Disorder in adults and adolescents between the ages of 10-17 years old.
  • Treatment of irritability linked to autistic disorder in young children and adolescents between the ages of 5-16.

The FDA emphasizes that some adverse reactions are more common than others. The most common adverse reactions to this drug include but are not limited to:

  • Somnolence (sleepiness)
  • Increased appetite
  • Fatigue Rhinitis (sneezing, congested or runny nose)
  • Upper respiratory tract infections
  • Vomiting
  • Nausea
  • Dizziness
  • Coughing
  • Urinary incontinence
  • Constipation
  • Abdominal pain
  • Anxiety.

Yet the FDA also identifies more serious adverse effects of Risperdal in young men, including the development of gynecomastia. As the prescribing information sheet clarifies, Risperdal “elevates prolactin levels,” and is in fact “associated with higher levels of prolactin elevation than other antipsychotic agents.” What happens when a patient has high levels of prolactin? That patient can develop harmful conditions, including gynecomastia. The FDA notes that gynecomastia was reported in 2.3 percent of male patients treated with Risperdal.

Direct Link Between Risperdal and Gynecomastia Alleged

For Risperdal-treated patients who developed gynecomastia, the potential harms of this antipsychotic medication were not made sufficiently clear. According to the Forbes article, Janssen Pharmaceuticals had evidence about the high rate of gynecomastia development among patients who took the drug, but it hid that information when it released a paper back in 2003.

By 2012, a study that examined the prevalence of gynecomastia among autistic boys who had taken Risperdal reported that “half of them ended up developing gynecomastia, or breast enlargement.” Of those young men who were taking Risperdal, about 50 percent showed elevated levels of prolactin. As we know, high levels of prolactin can be a cause of gynecomastia.

Patients and safety advocates argue that, back in 2003, Janssen Pharmaceuticals excluded from its paper “results showing a significant relationship between the increased prolactin in boys taking the drug and development of prolactin-related side effects.” The drug maker has already been cited for its failure to warn about the risk of developing gynecomastia when taking Risperdal, according to the article in The Wall Street Journal. And patients who have not yet filed a lawsuit may be eligible for compensation.

Contact a North Carolina and South Carolina Drug Injury Attorney

If you or someone you love developed gynecomastia after taking Risperdal, it is important to learn more about filing a claim for compensation. You should discuss your case with an experienced Asheville product liability lawyer as soon as possible. Contact Grimes Teich & Anderson LLP today to learn more about how we may be able to assist you with your case.

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