FDA Approved Uses for Risperdal

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Currently the Food and Drug Administration approves Risperdal to treat two psychological disorders: schizophrenia and bipolar disorder. These two conditions fall into the psychosis category, which means they can be characterized by hallucinations, delusions, drastic personality changes, and disorganized thinking. Psychosis is not a disorder in and of itself, but rather a symptom of a disorder or mental illness.

The FDA approved Risperdal to treat schizophrenia in 1993 and bipolar disorder in 2003. In order to receive FDA approval, a drug must go through several stages that demonstrate its effectiveness and safety.

There are four stages a new drug must complete before it is approved by the FDA. The first phase involves a small group of volunteers who take increasing doses of a drug. Once the safe level of the drug is established Phase II begins. Phase II tests involve large groups of between 100 and 300 people to test the effectiveness of the drug. Most drugs fail at this stage, but if the tests are positive Phase III experiments begin. At this point thousands of people engage in a double blind test of the drug, combined with a control group who take a placebo. If the drug survives this point it is ready to launch. Phase IV monitors post-launch side effect issues over a larger patient base for an extended period.

Even though Risperdal passed these phases and was approved to treat schizophrenia in 1993, many doctors began to prescribe it for conditions the developer never intended it to treat, such as senile dementia. Although not initially discouraged, these “off-label” prescriptions caused serious health problems and even 16 deaths before doctors discovered the true nature of Risperdal. In fact, Janssen Pharmaceutica issued a warning letter to Canadian doctors in 2002 warning about these potential risks, but waited until 2003 to inform American doctors of the same potential problems.