Risperdal is a prescription drug used to treat schizophrenia, bipolar disorder, and behavioral issues associated with autism. The drug’s active ingredient is risperidone. Risperdal was first approved by the U.S. Food and Drug Administration (FDA) in 1993. Risperdal is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
Janssen Pharmaceuticals has been admonished by the FDA and several government entities for marketing Risperdal for treatment in children. Risperdal was heavily prescribed to children from 1999 through 2006, when the FDA finally approved this usage. Janssen has paid nearly $2 billion in fines for deceptive marketing practices. The company also faces a number of lawsuits from patients harmed by Risperdal.
Risperdal Side Effects
The side effects of Risperdal range from minor to severe. More than one in 10 Risperdal patients have reported side effects including headaches, difficulty sleeping, and tremors. Other Risperdal patients may experience side effects such as back pain, blurred vision, coughing, dizziness, fever, and indigestion. Serious and life-threatening side effects have also been reported.
Decreased White Blood Cells
Risperdal patients can experience leukopenia, or decrease in white blood cell count. Neutropenia is a similar condition which involves a decrease in blood neutrophils. Neutrophils compose roughly 50 to 70 percent of white blood cells. Both of these conditions can lead to an increased bacteria level in the blood. This can cause potentially fatal infections.
Neuroleptic Malignant Syndrome
Neuroleptic malignant syndrome (NMS) is a deadly neurological disorder that is most often caused by neuroleptic or antipsychotic medications. Immediate intensive care is typically needed to treat NMS patients. Symptoms of NMS include sweating, high fever, unstable blood pressure, rigid muscles, and autonomic dysfunction.
Tardive dyskinesia (TD) is a disorder involving involuntary movements. TD is most often manifested in the lower face. This condition typically develops from using neuroleptic or antipsychotic drugs like Risperdal. It is characterized by involuntary grimacing, repetitive chewing, tongue thrusting, jaw swinging, and finger movement. TD can be a permanent disorder.
In 2012, Janssen Pharmaceuticals and Johnson & Johnson were ordered to pay $1.2 billion in fines in Arkansas. Tim Fox, the Arkansas Circuit Court judge, found the companies guilty of roughly 240,000 Arkansas Medicaid fraud law violations. Additionally, Janssen and Johnson & Johnson were fined $11 million due to their violations of the Arkansas deceptive practices act. Janssen Pharmaceuticals paid roughly $743 million in fines to Texas, South Carolina, and Louisiana in similar cases.
In 2004, the FDA sent a warning letter to Johnson & Johnson for misconduct in marketing Risperdal. The letter admonished the company for failing to disclose new research that risperidone drugs were linked to diabetes. The warning also asserted that the company misleadingly claimed that Risperdal was safer than other types of atypical, or second generation, antipsychotic drugs.
FDA Black-Box Warning
The FDA sent out an alert in 2005 regarding the increased risk of death in patients treated for dementia-related psychosis. These patients who took Risperdal and other atypical antipsychotic drugs showed a higher incidence of mortality than those who took a placebo.
The FDA required that Risperdal and similar antipsychotic drugs feature a black-box warning on the package labeling to warn users against this danger. The term “black-box” warning originates from the black outline that surrounds the text.
Janssen Pharmaceuticals and Johnson & Johnson face many claims that consumers were misled by both marketing and product packaging of Risperdal. Many allege that the manufacturers failed to adequately warn users of the side effects of taking Risperdal.
Risperdal patients who wish to file a claim against Risperdal manufacturers should speak with an experienced and knowledgeable attorney. Victims of Risperdal may be eligible to receive financial compensation for their injuries.