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Risperdal Associated with Male Breast Development

Jul 11, 2013

Federal regulators appear to be taking their time over issues involving Johnson & Johnson’s Risperdal, an antipsychotic medication associated with significant health reactions, including the development of gynecomastia in males.

According to one attorney, Johnson & Johnson should allow individuals alleging that the drugs caused them harm to release information provided by the drug maker during the discovery phase of their lawsuits, according to Philly.com. Instead, attorneys for the drug maker were able to persuade a Philadelphia judge to seal some data obtained from the company and the U.S. Food and Drug Administration (FDA) does not appear to be pushing the matter. Risperdal is sold through Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson.

According to one attorney, Johnson & Johnson should allow individuals alleging that the drugs caused them harm to release information provided by the drug maker during the discovery phase of their lawsuits, according to Philly.com. Instead, attorneys for the drug maker were able to persuade a Philadelphia judge to seal some data obtained from the company and the U.S. Food and Drug Administration (FDA) does not appear to be pushing the matter. Risperdal is sold through Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson.

Johnson & Johnson’s lead attorney wrote in a 2011 request to Philadelphia Common Pleas Court Judge Sandra Moss seeking that the request to release the documents to the FDA and the public be denied, "No legitimate purpose would be served by declassifying the documents identified by plaintiffs,” according to Philly.com. "Plaintiffs' counsel has expressed intent and desire to provide various of these documents to the press" and advised the judge that he "may petition the Food and Drug Administration to revoke various approvals for Risperdal use in children and adolescents," the attorney also wrote. Moss agreed.

Meanwhile, the Arkansas attorney general recently filed a brief backed by his peers in 35 states seeking to have the Arkansas Supreme Court uphold a $1.2 billion fine levied against Janssen Pharmaceuticals Inc., over the way in which it marketed the antipsychotic drug, Risperdal. Also, Johnson & Johnson previously chose to settle a lawsuit involving claims that Risperdal caused a male plaintiff to grow breasts (gynecomastia). The lawsuit was brought by Aron Banks, then 21, and was the first case to go to trial over Risperdal and claims that the drug caused gynecomastia, said Bloomberg.com previously.

The lawsuit is just one of hundreds against Johnson & Johnson and its Janssen unit over allegations of personal injuries related to Risperdal, the company indicated in a January 2013 regulatory filing. Of the more than 400 cases, about 130 involve allegations that Risperdal caused young males to develop breasts, according to Bloomberg.com. In this case, Banks alleged he suffered psychological trauma as a result of the breast growth he experienced when taking Risperdal when he was a boy from 2000 to 2004. At that time, Risperdal was not approved for use in pediatric patients.

In addition to its association with gynecomastia, prior studies on Risperdal’s efficacy revealed that more patients are likely to suffer stroke while taking Risperdal and are 50 percent more likely to develop diabetes than patients taking another drug in the same class. The drug has also been linked to side effects including, irregular heartbeat, weak muscles and muscle spasms, fever, weight gain and constipation, and headaches. Very serious side effects of Risperdal also include Neuroleptic Malignant Syndrome (NMS) and Tardive Dyskinesia.


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