Pharmaceutical

Former FDA chief claims Risperdal makers tried to cover up gynecomastia risks

risperdal Former FDA chief claims Risperdal makers tried to cover up gynecomastia risksJohnson & Johnson subsidiary Janssen Pharmaceuticals attempted to doctor data and scientific literature to downplay evidence that its antipsychotic drug Risperdal could create hormonal shifts in patients causing adolescent boys to grow female breasts, a condition known as gynecomastia, former Food and Drug Administration (FDA ) Commissioner David Kessler testified in front of a Philadelphia jury.

“What they want to convey here, as you see in their own words, doesn’t match what the data show and, to me, that’s not telling the whole story, especially when you’re taking about adverse events that are significant,” Kessler said in response to seeing an email from a Janssen employee expressing the desire to use a medical journal article to convey the safety of Risperdal despite underlying studies that found significant side effects with the drug.

“The one thing you have to do when you’re dealing with all medicines, including very powerful ones, is to tell the truth. You tell the whole truth, you tell the whole story, and you make sure that the data support what you’re saying,” he said.

Kessler reviewed documents that showed Johnson & Johnson and Janssen had considered removing data for boys older than age 10 from some studies for a proposed journal article. By doing so, Kesseler said, the “statistical significance disappears” for gynecomastia risks.

Risperdal, known generically as risperidone, is approved to treat adults and children with schizophrenia, bipolar disorder, and irritability in patients with autism. While the drug has been on the market for decades, it wasn’t until 2006 that the FDA granted approval for its use in pediatric patients. Risperdal continues to be prescribed off-label to treat behavioral problems including attention deficit hyperactivity disorder (ADHD) and attention deficit disorder (ADD).

Recent studies have linked Risperdal to serious side effects, including gynecomastia, or breast development in boys and young men. The condition can be emotionally and physically painful, causing tender breasts that sometimes lactate. Treatment can involve surgeries such as liposuction and mastectomy.

Kessler served as the FDA’s highest official for seven years in the 1990s. He is testifying as an expert witness in a lawsuit against Johnson & Johnson and Janssen filed by the family of a 20-year-old man with autism who grew large breasts after taking Risperdal for five years as a child.

The Pledger family claims that the companies’ failure to warn of the gynecomastia risks associated with Risperdal prevented them from making an informed decision about their son’s treatment options. Their son, Austin, took Risperdal for five years beginning in 2002, before the drug was approved to treat children.

The lawsuit is one of about 1,250 Risperdal gynecomastia lawsuits pending in Philadelphia County.

Source: Law 360