Patients who taking the antipsychotic drug Risperdal are at risk for falls that could result in injuries, the Food and Drug Administration (FDA) warned. The drug’s safety label was recently updated and approved by the FDA.
Risperdal, which contains the active ingredient risperidone, is FDA-approved to treat adults and children with schizophrenia, bipolar disorder, and irritability with autism. It is often used off-label to treat behavioral conditions including attention deficit hyperactivity disorder (ADHD). It is manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals.
The fall risk warning, which was also added to the Warnings and Precautions section on the safety labels of other atypical antipsychotic medications, reads “Somnolence, postural hypotension, motor and sensory instability have been reported with the use of antipsychotics, including Risperdal, which may lead to falls and, consequently, fractures or other fall-related injuries. For patients, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects, assess the risk of falls when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.”
Janssen is currently facing more than 10,000 lawsuits involving Risperdal side effects, specifically gynecomastia, a condition in which adolescent boys develop disfiguring breasts. Gynecomastia is typically treated with surgeries such as liposuction or mastectomy.
Any adverse events experienced while taking Risperdal should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Safety Label Changes (SLC)