J&J Misleading to FDA about Risperdal Gynecomastia Risk, at Ex-Regulator Says

Published on February 2, 2015 by Laurie Villanueva

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Johnson & Johnson failed to warn the U.S. Food and Drug Administration (FDA) in 2005 about the potential for one of its medications to cause male breasts, a former agency official said last week at trial for a Risperdal lawsuit.

The former FDA commissioner took the stand on January 31st for his third day of testimony, in which he said that the antipsychotic drug’s manufacturer was “at best” misleading that year about its association with gynecomastia, a condition referring to male breast growth, in adolescent boys. In 2006, the regulator expanded Risperdal’s approval to include the treatment of certain autism symptoms.

Risperdal Plaintiff Alleges Breast Growth after

The agency leader is currently serving as an expert witness for the plaintiff in this Risperdal lawsuit, which was filed by a 20-year old autistic man from Alabama who took the medication from 2002 through 2007. According to his claims of Risperdal gynecomastia, which are being argued right now in the Philadelphia Court of Common Pleas, the excess breast tissue that was allegedly caused by Risperdal needed to be removed via a mastectomy. This case is the first of more than 1,200 to head to trial over the medication, which is approved by the FDA to treat schizophrenia and bipolar disorder in adults and adolescents, as well as irritability in children with autism.

According to a report from Philly.com, a spokesperson for Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, issued a statement on January 30th that denies claims that they were less than forthcoming in their alerts about Risperdal gynecomastia. The companies “appropriately analyzed and reported data from clinical trials” she said on January 30th.

This is neither the first or last time Risperdal’s manufacturers will be asked to defend the medication’s safety. Not only has its association with gynecomastia been alleged in many of the 1,200 lawsuits now pending in the Philadelphia Court of Common Pleas, it has also been mentioned in charges brought by the federal government. In November 2013, court records indicate that Johnson & Johnson and Janssen agreed to pay more than $2.2 billion to resolve charges that Risperdal and several other drugs were promoted for uses not approved by the FDA. In their decision to resolve the claims, the companies admitted no wrongdoing in their marketing practices.

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