In our previous post we explored the history of the Risperdal’s development by the pharmaceutical company Janssen. Now let’s talk about how Janssen marketed Xarelto to children and adolescents without thoroughly testing the drug on this age group.
Although the drug was initially marketed to adults, Janssen has been trying to open up the market to children and adolescents since it was first released in the 1990s. In fact, the company sought FDA approval for use in this age group immediately after the drug was approved for adults. However, the FDA initially declined this request on the grounds that Janssen hadn't identified a use for Risperdal in children, nor had it provided any "data from adequate and well-controlled trials to support any such approvals."
To put it bluntly, Janssen was seeking to market a drug to kids without any evidence that it would be useful. Not only that, but the company hadn't even run tests to see if the drug would be safe for children and adolescents! This is neither ethical nor acceptable.
Unfortunately, the FDA's initial resistance did not stop Janssen from continuing their quest for approval. In 2000, the company tried to get Risperdal approved for children once again. The FDA turned them down and expressed frustration with Janssen's behavior.
Completely undeterred, Janssen decided to begin marketing Risperdal to children and adolescents without FDA approval. They developed a new business plan that focused attention on Risperdal, and they began instructing sales reps to market the drug to health professionals as a possible treatment for children with ADHD, obsessive compulsive disorder, autism and other such issues. Keep in mind that, at this point, the company had still neglected to adequately research the effects of this drug on children.
In 2002, Janssen refined its marketing efforts even further by developing the "Risperdal Child and Adolescent Market Segment: 2002 Business Plan Summary." Again, this plan was created to market a drug that was not approved by the FDA for use in children. Furthermore, research studies performed by external sources were now providing evidence of the dangerous side effects of Risperdal, especially for young patients.
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.