Risperdal, drugmaker Johnson & Johnson’s brand name for the generic drug risperidone, is one of the top-selling second-generation, or atypical, antipsychotic drugs on the market today.
Risperdal is responsible for over $2 billion in annual sales for its maker, many attributable to relatively untested ‘off label’ uses, for which the drug is not officially FDA approved.
The only uses Risperdal is FDA approved to treat are psychosis, schizophrenia related problems, and bipolar disorder. However, Risperdal is used to treat a variety of conditions in what are known as ‘off-label’ uses. While it is legal for physicians to write prescriptions for off-label drug uses, it is strictly illegal for drug manufacturers to market their drugs for these uses.
One major risk of off-label drug use is the lack of oversight into the effects of the prescribed drugs on the type of patients the drug is being prescribed to.
In the case of Risperdal, the drug has been shown to exhibit certain side effects, such as an increase in strokes and death among elderly patients, that has caused disproportionate harm to patients who were being prescribed the drug for age-related conditions such as dementia and Alzheimer’s disease.
Off Label Uses and Dangerous Side Effects
According to an analysis of Risperdal use by Knight Ridder Newspapers, it is estimated that, in 2002, about 670,000 Risperdal prescriptions were written for off-label use in dementia and Alzheimer’s disease in elderly patients.
Studies, however, have showed that Risperdal has been linked to dangerous and even deadly side effects in elderly patients, including an increased risk of strokes and infections, such as pneumonia. While Johnson & Johnson sent a letter to health professionals in 2003 warning of this increase in stroke risk, it was not until two years later that the information about these increased risks was made available to the public.
The FDA, in 2005, released a statement warning that second-generation, or atypical, antipsychotics had been linked to a serious increase in deaths from pneumonia and heart failure in elderly patients. As a result of these increased risks, the FDA required manufacturers of antipsychotics such as Risperdal to include strongly worded warnings about the heightened risk of death in elderly patients.
In a study done later that year, researchers compiled information from fifteen previous studies, including a study of Risperdal, and established that elderly patients taking atypical antipsychotic medications for off-label treatment of dementia were at 54% greater risk of death in the first twelve weeks of taking the drug, compared to patients who had been taking placebos.
In the compiled studies, 3,353 patients had been given atypical antipsychotics, including Risperdal, and 118 died during the study. 1,757 patients had received placebos, and only 40 of that sample had died.
Despite these alarming statistics, Risperdal is currently being prescribed to elderly patients in record numbers. A 2005 study in the Archives of Internal Medicine reported that over 200,000 Medicaid patients in nursing homes has been prescribed antipsychotic drugs but had received “no appropriate indications for use,” resulting in over half of the patients receiving incorrect dosages of those drugs.
Other common off-label and potentially dangerous uses of Risperdal include treatments for the following:
- Behavioral and conduct disorders, including in children
- Tourette’s Syndrome
- Panic and anxiety
What You Can Do
If you or someone you love was prescribed Risperdal, either for an indicated condition or an off-label treatment, and suffered from serious side effects that you think may have been caused by the drug, you owe it to yourself and your family to contact an experienced pharmaceutical injury attorney today to learn how you can get the compensation you need for the damages you’ve suffered.
Click here for detailed information on pharmaceutical injury law.