Risperdal is a powerful, antipsychotic drug used to restore the balance of the brain’s natural chemicals. The FDA approved Risperdal in 1993 to treat adult schizophrenia, acute mania, and mixed episodes associated with Bipolar I Disorder. Manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, Risperdal was marketed and prescribed to adolescents — even though the drug was not approved for that particular use until 2006. In 2006 and 2007, the FDA approved Risperdal for additional uses, including the treatment of bipolar disorder in adults and juveniles, schizophrenia in children, and certain behavioral symptoms in children with autism. However, the marketing of Risperdal prompted doctors to prescribe Risperdal for “off-label” usage, meaning it was not properly tested through trials or approved for that specific use by the FDA. There have been more than 13,000 adverse reactions reported to the FDA in connection with Risperdal, and the agency estimates that less than one percent of all serious events are ever reported. This indicates that the actual number of side effects occurring is likely much higher. A <a href="https://www.torhoermanlaw.com/black-box-warning/" target="_blank" rel="noopener noreferrer">black box warning</a>, the strictest warning put on prescription drug labels by the FDA, has been placed on the drug. More than 18,000 people nationwide have filed lawsuits against Johnson & Johnson, alleging that the company knew of the gynecomastia risks associated with adolescent Risperdal use without warning consumers. After risks became known, Johnson & Johnson did not strengthen labels with gynecomastia warnings, and lawsuits claim that J&J manipulated data and withheld key evidence from the FDA.

Who is Risperdal Prescribed For?

Risperdal is an antipsychotic drug first approved by the U.S. Food and Drug Administration in 1993 to treat adults with schizophrenia. During 2006-2007, the FDA approved additional uses for Risperdal, including treatment for: <ul> <li>Bipolar disorder in adults and juveniles</li> <li>Schizophrenia in children</li> <li>Certain behavioral symptoms in children with autism</li> </ul> Risperdal is an antipsychotic drug that works by blocking the activity of dopamine in certain areas of the brain. However, blocking dopamine also has an effect on the pituitary gland, causing a number of metabolic disruptions and resulting in the release of a hormone known as prolactin. Prolactin is responsible for stimulating breast tissue development and causing lactation in pregnant and nursing women, and for causing gynecomastia in adolescent males and in children as young as four. Gynecomastia can occur in one or both breasts and will not usually resolve, even if Risperdal use is discontinued. In mild cases, liposuction may be used to remove the tissue but in more extensive cases, breast reduction surgery or a mastectomy may be necessary.

Do I qualify to Participate in a Risperdal Lawsuit?

If you took Risperdal as a minor and have a documented diagnosis of gynecomastia, or developed physical or mental adverse symptoms from increased prolactin, contact us for a free, no-obligation consultation.

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Risperdal Lawsuit