Risperdal® (risperidone) is a powerful antipsychotic drug approved to treat schizophrenia, bipolar disorder, and irritability associated with autism. However, the drug may be linked to a variety of adverse side effects. One of the most disturbing is gynecomastia, the abnormal growth of breast tissue in young males. In some cases, mastectomies or other surgeries were needed to treat the problem.
Off-Label Marketing of Risperdal
Risperdal is made and sold by Janssen Pharmaceuticals, a Johnson & Johnson (J&J) subsidiary. It was approved in 1993 by the U.S. Food and Drug Administration (FDA). However, it has been estimated that approximately 70 percent of patients are prescribed the drug “off label” – or for uses not approved by the FDA. Many of those prescribed the drug off-label were children, since Risperdal was approved only for adult patients until 2007.
Risperdal sales practices have been under scrutiny by federal regulators since 2004, including allegations that the drug was marketed by the company for unapproved uses. In fact, in 2013, J&J agreed to pay $2.2 billion to settle an investigation by the U.S. Department of Justice into allegations that it illegally marketed Risperdal and other drugs. Thousands of men have also come forward and filed lawsuits alleging they developed gynecomastia after taking Risperdal as a minor.
File a Risperdal Lawsuit
If you or a loved one are a male who took Risperdal as a minor and developed gynecomastia, you may be entitled to compensation. Contact Sokolove Law today for a free legal consultation to learn more.
Patients are urged to always seek a doctor’s advice before stopping or making changes to any medication regimen.
Risperdal® and Invega® are registered trademarks of Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson.