- After paying a $2.2 billion settlement to the Department of Justice in 2013 for off-label marketing of Risperdal (risperidone), Johnson & Johnson (J&J) has come under scrutiny again for failing to warn parents about certain side effects, including boys growing breasts.
- Risperdal is an antipsychotic that was first indicated for the treatment of schizophrenia; however, it was given additional FDA approvals over the years, including a pediatric approval. But before Risperdal was given a pediatric approval, many physicians were prescribing it off-label for children, including autistic children. Much of the information they received to support their prescribing came from sales reps.
- Now, two Alabama parents are suing on behalf of their autistic son, who was taking Risperdal five years before the FDA approved it for use in children with autism. As a result of treatment with Risperdal, the boy developed breasts—a side effect that was apparent in a J&J-conducted study, but not properly communicated until years later.
Risperdal and other antipsychotics in this class have been dogged by claims of adverse events, including excessive weight gain, hyperprolactinemia, and gynecomastic (breast growth) in boys. Many of these adverse events were well documented; however, risperdal has solid empirical and clincial data attesting to its efficacy at addressing psychiatric symptoms.
The issue here is not the efficacy of Risperdal. Rather, it's the fact that J&J had study data dating back to 2001 in which 3.8% of boys in a clinical trial developed breasts—and this information was not communicated by reps who were communicating with physicians who were regularly using Risperdal to treat pediatric patients with autism.
Despite the fact that J&J finally added a gynecomastia warning to the Risperdal label in 2006, some boys were adversely affected in the interim. Former FDA Chief David Kessler testified in Philadelphia earlier this week to that effect. The outcome of the case is still unknown.