” David Kessler, the former U.S. Food and Drug Administration commissioner, testified Wednesday that as a pediatrician, it “certainly is a red flag to me” that a Janssen Pharmaceuticals Inc. study of the use of its antipsychotic drug Risperdal in young children and adolescents, mainly boys, showed high rates of breast growth.
Risperdal was originally approved in 1993 only to treat psychotic disorders in adults. “On March 3, 2002, the approved use was narrowed to treatment of schizophrenia only,” phrasing used by the Justice Department in 2013 in its statement after J&J agreed to pay $2.2 billion for settle one criminal charge and other allegations that it illegally promoted Risperdal for unapproved uses.
Doctors are allowed to prescribe medicine as they see fit, including “off-label,” meaning for conditions not approved by the FDA and on the official label. Drug companies are not supposed to promote drugs for illnesses or for a group of patients for whom the drug is not approved and not on the label. But the squishiness of definitions of mental illness opens the door even wider for drug companies do such promotion. ”
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Sources and more information
- Mother brought to tears hearing Johnson & Johnson’s Risperdal tactics,
phillypharma, January 30, 2015.
- Former FDA chief testifies for plaintiff in Risperdal case,
phillypharma, January 28, 2015.
- Risperdal Male Breast Growth Class Action Lawsuit Settlement Claims & Lawyers 2014, nationalinjuryhelp, 2015.
- J&J’s $2.2 Billion Settlement Won’t Stop Big Pharma’s Addiction To Off-Label Sales, forbes, 11/12/2013