Former FDA Chief Testifies in Risperdal Gynecomastia Lawsuit

Former FDA Chief Testifies in Risperdal Gynecomastia LawsuitJanuary 30, 2015 — Former U.S. Food and Drug Administration (FDA) commissioner Dr. David Kessler has testified against Johnson & Johnson in a trial involving Risperdal, an anti-psychotic drug linked to severe gynecomastia (breast growth) in young men.

Dr. Kessler pointed out a study from 2001 that showed 3.8% of boys given Risperdal developed breasts, where were “probably or very likely” caused by the drug, according to Bloomberg.

As a pediatrician, Kessler said it “certainly is a red flag to me” that the study showed high rates of breast growth, the Philadelphia Inquirer reports.

The lawsuit was filed on behalf of Austin Pledger, a 20 year-old man from Alabama who gained 100 pounds and developed gynecomastia after taking Risperdal for five years.

Lawyers accuse Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, of hiding evidence that Risperdal could cause abnormal breast development in boys. Pledger’s lawsuit is the second case out of more than 1,250 similar lawsuits to go to trial in Philadelphia.

In 2013, the Justice Department ordered Janssen to pay a $2.2 billion settlement for illegal “off-label” (unapproved) marketing of several drugs. Despite warnings from the FDA, Janssen allegedly targeted Risperdal to children from 1999-2005. The FDA did not approve Risperdal for irritability associated with certain intellectual disabilities until 2006.

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