Australian Gov’t Questions Antipsychotic Drug Uses; Risperdal Lawsuit Plaintiffs Accuse J&J of Off-Label Marketing

Published on June 9, 2014 by Laurie Villanueva

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More than 12,600 Australian children under 19 are now taking an atypical antipsychotic, including one tied to breast development in hundreds of Risperdal lawsuit filings, according to

In a report published by the federal government’s Drug Utilisation Subcommittee, use of these medications is on the rise, with more than 2,000 patients under nine years old being prescribed an antipsychotic drug by doctors. According to a June 7th report from in Australia, 110 children under the age of four are taking the medications for autism, schizophrenia and acute mania. These findings are “concerning given the potential harms associated with the use of antipsychotics even at low doses,” according to the Australian government.

A psychiatrist quoted by says the results of this report question whether other methods are being considered when it comes to treating psychotic conditions. “If there had been a 138 per cent increase in any other brand of medicine for insulin or asthma we would be questioning what was going on,” he said.

AU Doctors Question Uses of Risperdal in Children

Another doctor goes on to say that antipsychotic drug scripts for children under five years should only be written by specialists and for symptoms associated with aggression management in relation to austism or schizophrenia. But how many children under five have been diagnosed with schizophrenia, which is one of Risperdal’s approved uses by the U.S. Food and Drug Administration (FDA)? Very few, he says, which might lead some to wonder how often this Johnson & Johnson drug and several others are prescribed for anxiety and other conditions.

“Schizophrenia … is very, very rare in the under fives and frankly I don’t think in my proactive (of over 40 years) I have ever seen a child under five with schizophrenia,” added the psychiatrist.

This is not the first time off-label uses of antipsychotic drugs have been called into question, though. In addition to being alleged by hundreds of Risperdal gynecomastia lawsuit claimants, the off-label use of this medication and several others was a subject of concern in Johnson & Johnson’s recent settlement with the U.S. government. After the U.S. Department of Justice accused the company of promoting the use of Risperdal in children before it was approved for pediatric uses in 2006, the $2.2 billion agreement was reached in November 2013.

At least 350 lawsuits alleging Risperdal gynecomastia, a condition categorized by male breast development, have also been filed by men who developed the painful and embarrassing condition. These claims are pending in a consolidated litigation underway in the Philadelphia Court of Common Pleas.

File a Risperdal Gynecomastia Lawsuit

Call an attorney at Bernstein Liebhard LLP to learn more about Risperdal gynecomastia lawsuits, and whether you may be eligible to file a case of your own at .