Risperdal Side Effects
Risperdal has been found to cause the development of breasts and milk secretion in young boys. Male breasts are caused by an increased level of a hormone called prolactin that regulates the growth of breast tissue. A 2006 study published in the Journal of Clinical Psychopharmacology found that risperidone, the generic version of Risperdal, increased prolactin levels in adolescents when taken at similar dosage level to treat psychiatric symptoms. As a result, in young men and children breast growth is enlarged. This is a condition also known as gynecomastia.
Researchers advised that risperidone should be administrated with caution to children and adolescents.
If you or a loved one is currently taking Risperdal, talk to a doctor before discontinuing use. Always discuss the benefits and risks of discontinuing use of any medication with a physician.
Risperdal has been linked to serious side effects and health complications among children and adolescents taking the drug. Young men and boys who took the drug may develop male breast tissue and subsequently experience psychological trauma and the need for surgery to remove the breasts.
If you or a loved one has experienced such complications from use of Risperdal, you may be eligible to file a lawsuit.
Background of Risperdal Lawsuits
A lawsuit filed by the U.S. Department of Justice states that Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson and the maker of Risperdal, failed to disclose information on the serious side effects of Risperdal while marketing it for off-label uses in children.
According to the complaint, the pharmaceutical manufacturers “knew Risperdal posed certain health risks to children.” Regardless of this knowledge and repeated warnings from the U.S. Food and Drug Administration (FDA), the company continued to market the drug for off-label uses.
“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger, regarding the government settlement agreement. “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”
As a result of the lawsuit, Johnson & Johnson and Janssen Pharmaceuticals agreed to pay $2.2 billion to resolve the claim that the company falsely marketed and misbranded multiple prescription drugs, including Risperdal.
What is Risperdal?
Also known by the generic name risperidone, Risperdal is a powerful, anti-psychotic medication prescribed to treat schizophrenia, autism and bipolar disorders. It was first approved by the U.S. Food and Drug Administration (FDA) in 1994 for the treatment of schizophrenia in adults. In 2006, Risperdal was approved for use in children and adolescents experiencing irritability from autism. In 2007, the drug was approved to treat schizophrenia in ages 13 to 17 and bipolar disorder in ages 10 to 17.
Off-Label Uses of Risperdal for Children
Risperdal was allegedly marketed before it was approved for adolescent use by the FDA. The drug was promoted to treat the following childhood disorders:
- Attention deficit hyperactivity disorder
- Oppositional defiant disorder
- Obsessive-compulsive disorder