Risperdal Legal Recourse: The Johnson and Johnson Study

Published on August 28, 2015 by

By 2003, multiple research studies indicating that Risperdal might be dangerous for patients, especially children, began drawing negative attention to Janssen and its marketing practices. In response, parent company Johnson & Johnson published a paper entitled "Prolactin levels during long-term Risperidone treatment in children and adolescents." The paper stated that, although Risperidone does affect prolactin levels in children and adolescents, "serum prolactin levels tended to rise and peak within the first 1 to 2 months and then steadily decline to values within or very close to the normal range by 3 to 5 months."

Based on the results of this study, it seems like the hyperprolactinemia caused by Risperdal is short-lived. However, the study was not without flaws. Namely:

  • The study analyzed five different clinical trials with relatively small sample sizes. Larger sample sizes would be required in order to draw reliable conclusions.
  • Although the paper indicates analysis of "long-term Risperidone treatment," two of the clinical trials studied only short-term treatment. These trials did not provide any information about what would happen to patients who continued taking the drug for longer periods of time.
  • The paper's abstract purposefully excluded the demographic of boys aged 10 and older from the results. Excluding these patients from the results artificially lowered the incidence of adverse outcomes reported, thus making the drug appear to be safer for this population than it actually is.

In spite of these issues, the release of the study marked a success for Janssen Pharmaceuticals. On the heels of this victory, Janssen applied for FDA approval of Risperdal for use in children once again in 2005. The FDA again said "no." Janssen responded by launching its largest marketing campaign yet with the intention of selling the drug to children and adolescents off label.

The FDA finally succumbed to Janssen's requests for approval in 2006 and 2007. However, the FDA's approval did not make Risperdal any safer, and countless children had already taken the drug off-label anyway.

If you believe that you or a loved one is experiencing symptoms of gynecomastia after using Risperdal and are interested in pursuing legal action as a result, contact the team here at Marc Whitehead & Associates, LLP by calling 855-423-3666. We will be happy to review your case and explain your options.

For more information regarding the harm of Risperdal, download a free copy of our e-book, Risperdal: The Shocking Truth-Marketing Fraud Adds Up to Billion$ While Boys & Young Men are Irreparably Harmed. Be sure to check back each week for more updated information on the legal battle against the manufacturers of Risperdal.