Antipsychotic, Risperdal, Associated with Male Breast Development

risperdal_male_breast_growthRisperdal, an antipsychotic medication manufactured through Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson, has been associated with significant health reactions, including the development of gynecomastia in males—male breasts.

A number of lawsuits have been filed alleging injuries related to Risperdal and, according to one attorney, Johnson & Johnson should allow individuals who allege that Risperdal 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 persuaded a Philadelphia judge to seal some data obtained from the drug maker. The U.S. Food and Drug Administration (FDA) does not appear to be pushing the matter.

After the petition to release the information was filed, the “FDA asked the company to submit all available data regarding use of these medicines in children and adolescents as required by the applicable federal regulations,” said Teresa Mueller, company spokeswoman, in a statement, according to Philly.com. “Janssen submitted a formal response to this request and confirmed that we have provided all of the available data requested concerning these products.”

Johnson & Johnson’s lead attorney wrote, in a 2011 request to Philadelphia Common Pleas Court Judge Sandra Moss, seeking that the attorney’s 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,” the drug maker’s attorney wrote, 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, Arkansas’ attorney general recently filed a brief that was backed by his peers in 35 states that sought to have the Arkansas Supreme Court uphold a $1.2 billion fine that had been levied against Janssen Pharmaceuticals Inc., over the way in which it marketed Risperdal. Also, Johnson & Johnson previously chose to settle a lawsuit involving claims that Risperdal caused a male plaintiff to grow breasts (gynecomastia). That lawsuit, brought by then-21-year-old Aron Banks, was the first case to go to trial over Risperdal and involved Banks’ claims that the drug caused gynecomastia, said Bloomberg.com previously.

The lawsuit is just one of some 420 against Johnson & Johnson and its Janssen unit over allegations of personal injuries related to Risperdal, the company indicated in a January 2013 regulatory filing. About 130 of the cases involve allegations that Risperdal caused young males to develop breasts, Bloomberg.com previously indicated. In this case, Banks alleged he suffered psychological trauma from breast growth he experienced when taking Risperdal when he was a boy from 2000 to 2004. At that time, Risperdal was not approved for pediatric patients.

Risperdal is an expensive and dangerous option among other drugs in its class and prior studies on the drug’s effectiveness found 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 like an irregular heartbeat, weak muscles and muscle spasms, fever, weight gain and constipation, and headaches. Serious side effects of Risperdal include Neuroleptic Malignant Syndrome (NMS) and Tardive Dyskinesia.

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