Risperdal is an antipsychotic drug that carries a black-box warning which specifically warns the drug’s possible fatal effect to elderly patients who have dementia-related psychosis. Despite of this, nothing would change the fact that Risperdal was once-upon-a-time on a spotlight as one of the best-selling antipsychotic medicines in the United States.

It all started when the Food and Drug Administration approved Risperdal for treating schizophrenia in adults back in 1994. Since the drug’s creation, its manufacturer, the healthcare giant Johnson and Johnson, have been trying to get the Food and Drugs Administration to expand the drug’s usage for younger and older patients. Despite of FDA’s denial to this request, Johnson and Johnson had been marketing Risperdal for off-label uses to where the drug is extensively promoted to treat Attention Deficit Hyperactivity Disorder (ADHD) in children, Post Traumatic Stress Disorder (PTSD), insomnia, behavioral disorders, psychosis, aggression and agitation. The off-label marketing of Risperdal is obviously the reason why it was once the most popular antipsychotic drug in the United States.Risperdal may be an FDA-approved prescription medication at some point but the drug carries a black-box warning or the most serious health warning by the Food and Drug Administration. This warning indicates that a patient is risking his life to the serious adverse effects that could lead to health issues, or worse, death. Those elderlies who have dementia-related psychosis are more prone to death when taking Risperdal.

Risperdal Black-Box Warning

Janssen, and its parent company Johnson & Johnson were required by the FDA to put a black box warning on the label of these drugs. This warning is a set of text wrapped in black border; hence called black box warning. Risperdal black box warning as issued in 2005, read as;This black-box warning as issued by the Food and Drug Administration to Risperdal was based from gathered clinical evidences.

Risperdal’s Fatal Effects to Patients Who Have Dementia-related Illnesses

Be warned, even though Risperdal posses an emphasized black-box warning, it is still widely prescribe to treat dementia-related symptoms. Older adults who have dementia may also experience any of the following serious side effects;

• stroke, mini-stroke, aneursym
• neuroleptic malignant syndrome
• parkinsonism
• hyperglycemia
• dyslipidemia
• dysphagia

Given the numbers of serious health problems that Risperdal and Invega can potentially bring, it is no wonder why hundreds of lawsuits are filed against Johnson and Johnson up until today. The number of lawsuits is still growing.