Risperdal has been used for years in the treatment of schizophrenia, bi-polar mania, and irritability associated with autistic disorder in children and adolescents. In addition, Clinical studies involving small numbers of patients have shown some benefit in using Risperidone for stuttering and Tourette’s syndrome though these are non FDA-approved uses. Another non-FDA approved use of risperidone is for obsessive-compulsive disorders.
Unfortunately, over the years there have been numerous complaints and claims filed regarding the diverse side effects of the drug. These severe side effects include hyperglycemia and diabetes sometimes leading to death. Another unpleasant side effect would be the development of breasts in young men taking Risperdal.
September 11, 2003 the FDA notified Janssen Pharmaceutica, Inc. (through Johnson & Johnson Pharmaceutical Research & Development, L.L.C.) of the new warning requirement. On November 6, 2003, Janssen submitted supplemental NDAs covering an addition of the information to the Warnings section of the PI for Risperdal. However, instead of notifying doctors and patients in a letter of the additional warning added to the label, they omitted that important material information. This letter minimized the risks and was misleading. The read as follows:
“Hyperglycemia-related adverse events have infrequently been reported in patients
receiving RISPERDAL. Although confirmatory research is still needed, a body of
evidence from published peer-reviewed epidemiology research suggests that
RISPERDAL is not associated with an increased risk of diabetes when compared to
untreated patients or patients treated with conventional antipsychotics. Evidence also
suggests that RISPERDAL is associated with a lower risk of diabetes than some other
studied atypical antipsychotics.”
In conclusion it is obvious that Janssen intentionally put consumers at risk and as a result these consumers have suffered. Recently the pharmaceutical company has lost several class action law suits because of their deceptive marketing tactics.