FDA Says Risperdal Clinical Trial Data Was Manipulated

FDA Says Risperdal Clinical Trial Data Was ManipulatedEarlier this year, a Philadelphia jury awarded $70 million to a Tennessee man in a lawsuit against Johnson & Johnson and its Janssen Pharmaceuticals division for failing to warn that the antipsychotic drug Risperdal can cause gynecomastia, a condition that triggers breast development in boys and young men.

During trial, former Food and Drug Administration commissioner David Kessler was shown on videotape testifying that the companies manipulated the data in Risperdal clinical trials prior to the drug’s approval in 1993 to downplay the risks of gynecomastia.

Typically prescribed for use in adults with schizophrenia, Risperdal has also been prescribed for children with ADHD and aggressive behaviors, even though the FDA did not approve the drug for pediatric use until 2006. J&J paid $2.2 billion in fines in 2013 after the U.S. Department of Justice accused the company of marketing the drug illegally.

Risperdal has been shown to increase the levels of prolactin in the body, which is responsible for breast growth in women. These increased prolactin levels can create breast development in boys and men. Prolactin occurs normally in the bodies of boys after the age of 10, at the onset of puberty.

Johnson & Johnson and Janssen Pharmaceuticals allegedly manipulated the trial data by excluding boys over the age of 10 in their Risperdal clinical trials from the number of children that developed gynecomastia. This skewed the gynecomastia rate from the actual 4.5% to only 0.8%. Later studies showed that the rate is approximately 5.5%.

Using this faulty data, the companies allegedly sought FDA approval for the use of Risperdal in treating children with autism. That approval was granted in 2006. Later, the companies were ordered to pay $2.2 billion in civil and criminal penalties for illegally marketing Risperdal for use in children and misrepresenting the risks.

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