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More than 600 Risperdal Lawsuit Claims Have Been Filed Alleging Male Breast Growth after Using Antipsychotic Drug
Date:8/9/2014

f Justice (DOJ) reported that in 2013 that Johnson & Johnson’s subsidiary Janssen Pharmaceuticals Inc. plead guilty to misbranding the antipsychotic drug Risperdal and agreed to pay a $400 million criminal fine. This came after an investigation by the DOJ and the FDA for marketing Risperdal without FDA-approval for use in children with behavior challenges, despite Risperdal's known health risks to children and adolescents. According to the DOJ, the FDA repeatedly advised the company that promoting Risperdal's use in children was evidence of a violation of law. Risperdal was not approved for use in children for any purpose until late 2006, according to the Justice Department. Janssen Pharmaceuticals Inc. was also investigated for marketing the Risperdal drug for use in elderly dementia patients that had not been approved by the FDA. As a result of the investigation, the justice department charged Janssen Pharmaceuticals, Inc., with introducing a misbranded drug into interstate commerce. Janssen Pharmaceuticals, Inc. also paid $1.25 billion to settle a separate civil case regarding Risperdal.
[justice.gov/opa/pr/2013/November/13-ag-1170.html, November 4, 2013]
[fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373499.htm, November 4, 2013]

Risperdal is an atypical antipsychotic drug approved by the U.S. Food & Drug Administration (FDA) to treat schizophrenia, bipolar disorder, and irritability in autistic children and adolescents. Recent studies have cited concerns over an increase in children being prescribed antipsychotic drugs, including Risperdal. A report released in June by the Australian government’s Drug Utilization Subcommittee estimated 12,680 Australian children less than 19 years old were taking an antipsychotic drug as of October 31, 2012. According to the report, risperidone, sold in the U.S. under the name “risperdal,” was the most common drug taken by children 14 years old and under. In Australia, risperidone i
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