Risperdal: Dangerous Side Effects in Children and Young Adults

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).

More information

J&J Janssen Pharmaceuticals loses first Risperdal jury trial

Gynecomastia, enlargement of breast tissue in males, was an adverse effect of using the antipsychotic drug Risperdal

risperdal drug image
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.

Sources and more information
  • Man, 20, awarded $2.5M in damages after drug gave him breasts, philly, February 25, 2015.
  • Johnson & Johnson loses first Risperdal jury trial, philly, February 25, 2015.

Is J&J Risperdal drug causing breasts in young boys?

David Sell reports for Philly Pharma, 2015

Risperdal-tablets image
The antipsychotic Risperdal by Johnson & Johnson’s Janssen Pharmaceuticals.

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. ”

Read more via the links below…

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 Salesforbes, 11/12/2013