Risperdal is an effective drug for treatment of various degrees of psychosis and schizophrenia, ADHD and bipolar disorder. However, like other pharmaceuticals, there are Risperdal side effects, some of which can be particularly harmful to the elderly and children.
Last year the makers of Risperdal settled for $15.5 million a lawsuit filed by the Attorney General for the State of Kentucky. The lawsuit accused the makers of Risperdal of not disclosing risks associated with the drug to consumers, and marketing Risperdal for uses other than originally intended or approved for by the U.S. Food and Drug Administration (FDA). This has caused excessive and unnecessary costs to Medicaid and Medicare in the state, according to the lawsuit.
Among the allegations brought by the state of Kentucky was that the makers of Risperdal marketed the drug as an appropriate treatment for dementia in non-schizophrenic elderly patients. It was alleged that a study undertaken by the drug company had suggested death rates among the elderly in association with Risperdal use doubled the risk of death. And yet, not only did the makers of Risperdal market and promote the drug for use among the elderly for a use not approved by the FDA, they created an elder care sales force to further target the elderly market, according to the lawsuit.
Manufacturers are not allowed to actively market and promote a pharmaceutical for purposes beyond the scope of indications formally approved by the FDA. While doctors and other qualified health care professionals can prescribe a medication off label, it is illegal for a sponsor or a manufacturer of the drug to do so.
The Kentucky lawsuit asserted that even though Risperdal was approved for use in children with ADHD in 2007, Janssen actively marketed Risperdal to children and the youth market before it was formally approved for that constituency of patients. The Risperdal side effects that have proven to be a major event for some males is Risperdal gynecomastia, which is the development of male breasts stemming from a hormonal imbalance triggered by Risperdal (risperidone).
Gynecomastia has been a source of embarrassment and emotional trauma for many young men, especially since male breast tissue may not disappear once Risperdal is stopped and often requires a surgical breast reduction. In some males, one breast might enlarge more than the other or in isolation – and in rare cases some boys have begun to see discharge from their nipples.
It was alleged in the Kentucky lawsuit that the makers of Risperdal knew of the potential for Risperdal gynecomastia, but resisted any attempt to update the warning label over fear of losing up to $150 million per year in sales, or so it was alleged.
Gynecomastia side effect associated with Risperdal is now the center multiple lawsuits filed by men who developed breasts after taking the drug. Our law firm is currently investigating Risperdal lawsuits from across the country. If you or a loved one suffered from Gynecomastia after taking Risperdal, contact our office immediately.