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Risperdal®, the marketed name for the generic drug risperidone, was approved by the Food and Drug Administration in 1994 to treat the brain disorder schizophrenia. Risperdal® is known as an “atypical antipsychotic” medication and works by altering brain chemistry in order to help alleviate the symptoms associated with serious brain disorders. Unfortunately, Risperdal® has led to serious and distressing side effects among many patients that it was designed to help.

Off-Label Usage

Occasionally, drug manufacturers will encourage doctors to prescribe medications to treat conditions for which the drug was not originally approved by the FDA. This is known as “off-label” usage, and in some cases, this practice can actually be extremely beneficial to patients. However, it is far more common for this type of off-label usage to lead to serious and unintended side effects that may have devastating consequences for patients.

Manufacturer Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, promoted this type of off-label treatment for patients using Risperdal despite a lack of testing and information. Off-label uses that were approved for the antipsychotic Risperdal® included the treatment of bipolar disorder in 2002 and Autism in children in 2006.

These types of off-label treatments allowed Risperdal® profits to soar. Sales of the medication peaked in 2007 at $4.5 billion, and even despite recent legal trouble and backlash against the manufacturer, Risperdal profits were still reported at $1.5 billion in 2013. Numerous lawsuits now allege that Janssen Pharmaceuticals pushed these off-label uses for approval as early as the 1990s, and worked to hide or ignore mounting evidence of severe side-effects caused by Risperdal®.

Risks Associated with Risperdal®

Risperdal is an antipsychotic medication designed to help an extremely vulnerable community of patients. Psychosis and personality disorders associated with schizophrenia, autism, and bipolar disorder are incredibly difficult to deal with, especially among younger patients. In order to treat these disorders, Risperdal® fundamentally alters a patient’s brain chemistry. Unfortunately, one of the major side effects of this medication is that it can lead to a severe hormone imbalance in some patients.

In young and adolescent men, in particular, Risperdal® can cause a hormone imbalance that causes a condition known as gynecomastia, or swelling of male breast tissue. Gynecomastia can lead to severe mental and emotional distress among young patients, and may require surgery to completely remove the breast tissue; a procedure known as a mastectomy.

Another population at risk of serious, or even fatal side effects from the drug are elderly patients taking Risperdal to treat Dementia-related psychosis. The FDA announced in 2005 that elderly patients faced an increased mortality rate when taking Risperdal®.

Other side effects of Risperdal can include:

• Nausea & Vomiting
• Tremors
• Dizziness
• Fatigue & Sedation
• Anxiety