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Risperdal®: Risk of Breast Development in Boys
Attorney Stephen Sheller of the Philadelphia law firm Sheller, P.C. discusses the dangerous side effects of Risperdal®, including gynecomastia (development of breasts in male children).
Gynecomastia, enlargement of breast tissue in males, was an adverse effect of using the antipsychotic drug Risperdal
After a trial that lasted almost a month, the 12-member Philadelphia jury in the Austin Pledger – the plaintiff in the case – v. Johnson & Johnson Janssen Pharmaceuticals, ordered J&J to pay $2.5 million to the 20-year-old autistic man from Alabama who developed 46DD breasts while taking the Risperdal antipsychotic drug.
Austin Pledger took Risperdal to assist with behavioral symptoms related to autism and claimed to have developed gynecomastia from taking the drug. The young man argued that J&J knew for years that the drug could cause gynecomastia, but kept the data to itself rather than telling the FDA. The agency added a warning about the condition to Risperdal’s official label in 2006, four years after this trial plaintiff started taking the drug in 2002.
Austin Pledger’s lawsuit is the first of more than 1,000 similar cases pending over Risperdal’s breast-growth side effects.
David Sell reports for Philly Pharma, 2015
” 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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