|Former FDA Commissioner David Kessler|
Johnson & Johnson ($JNJ) knew as early as 2001 that its antipsychotic drug Risperdal could cause boys to grow breasts, former FDA chief David Kessler testified in a Philadelphia court Wednesday. That's 5 years before the company added a warning about the side effect to the drug's official label.
Kessler pointed to a 2001 study showing that 3.8% of boys using Risperdal in a clinical trial developed breasts, a condition known as gynecomastia. The drug "probably or very likely" triggered the problem, Kessler said in court (as quoted by Bloomberg).
Funded by J&J, the study "certainly was a red flag," Kessler said.
Kessler's testimony backs two Alabama parents who sued on behalf of their autistic son, who had been taking Risperdal for 5 years before the drug was FDA-approved for use in autistic kids, the Philadelphia Inquirer reports. Doctors can prescribe drugs for unapproved uses, but companies are only allowed to promote their products for FDA-approved indications.
Now 20 years old, the plaintiff claims that Risperdal caused his breast development and accuses J&J of hiding the risk. It's one of more than 1,000 cases making similar claims in Pennsylvania state court. The company settled the first such case in 2012.
His pediatric neurologist testified Monday, saying that sales reps from J&J's Janssen unit had dropped off Risperdal samples 20 times between 2002 and 2004, years before the drug's first pediatric approval. J&J in 2013 agreed to pay $2.2 billion to settle Department of Justice and state allegations that it marketed Risperdal for off-label uses, including use in children and adolescents. Two other J&J drugs were also involved in the settlement.
Janssen says that the company's warnings were complete and proper, and that it did not mismarket the drug, Bloomberg says. In a statement provided to the news service, a Janssen spokeswoman said Risperdal "has improved the lives of countless children and adults throughout the world who suffer from debilitating mental illnesses, and it continues to improve patients' quality of life today."