Between 1993 and 2007, the U.S. Food and Drug Administration (FDA) approved the use of the antipsychotic drug Risperdal as a safe and successful treatment for several psychological disorders that affect children and adults. The diagnoses that were listed to benefit from this drug included bipolar disorder and schizophrenia in children and adults and dementia in senior citizens.
After the initial approval, Janssen Pharmaceuticals, a division of Johnson & Johnson and the makers and marketers of Risperdal, began to promote the drug as an effective treatment for off-label conditions—disorders not approved by the FDA. These included:
- Childhood ADD for children as young as two
- Behavioral disorders caused by autism, for both children and adults
- Sleep disorders
For a time, the drug was the most widely prescribed antipsychotic medication in the United States. Sales generated over $4.5 billion in 2007, and Risperdal continues to generate over $3 billion annually along with its sister-drugs—Risperdal Consta (injectable), Risperidone (generic), and Invega.
Lawsuits Against Makers of Risperdal
Despite its popularity, Risperdal has been linked to serious side effects. Many consumers and even several states have brought civil action lawsuits against Jansen Pharmaceuticals, accusing the company of advocating false information to the state boards of public health that the drug was completely safe.
Furthermore, the lawsuits allege that the drug makers deliberately covered up the severity of side effects and advocated to doctors that they should prescribe the medication more—marketing the drug as a remedy for additional but non-FDA approved conditions to increase overall sales.
Risperdal Side Effects
Investigations into the physical effects of Risperdal have indicated an association with the drug and the following conditions:
- Tardive dyskinesia (TD) and movement disorders. As the drug impacts the synapses in the brain (to control psychotic episodes), it can also trigger involuntary muscle movements similar to Parkinson’s disease. In addition, patients may suffer from restlessness; an inability to move; abnormal movement of the face, shoulders, arms, or legs; tremors; stiffening of the tongue resulting in difficulty breathing, and Neuroleptic malignant syndrome—a potentially fatal condition that can cause severe muscle rigidity and spikes in blood pressure and pulse.
- Mental degeneration. When taking Risperdal, there may be a slowing of cognitive and mental processes in young kids.
- Breast development in young boys. An increase of prolactin, which is triggered by Risperdal use, triggers the production of breast tissue. The hormone is normally common in women who are pregnant or nursing; however, when it’s introduced into a boy’s body, the resulting growth may require surgery to remove.
- Lactation in young girls and women who are not pregnant or nursing. The increase of prolactin can also affect the breast maturity of young girls. In addition to permanently increasing the breast size, the hormone can also induce lactation in girls and women as the body assumes the raised prolactin level is due to pregnancy.
- Diabetes in both adults and children. According to the Department of Health and Human Services, for patients who already have diabetes, taking Risperdal has been shown to worsen the condition. Those patients who did not suffer from the condition prior to taking the drug are at an increased risk for weight gain and diabetes. Expert witnesses in a Texas lawsuit involving Risperdal testified that Johnson & Johnson withheld data from at least three different studies all linking Risperdal use to the risk of diabetes. J & J is believed to have known about the existence of these studies as far back as 1999.
- Strokes in the elderly. Elderly patients taking Risperdal while also suffering from dementia have shown an increased risk of mortality. The actual cause of death in these patients was cardiac failure, pneumonia, and stroke.
If You Were Injured After Taking Risperdal
If you or a loved one suffered injuries after taking Risperdal, we are here to help. Contact us for a consultation at 888-526-7616. Because of the potential side effects of Risperdal, Jansen Pharmaceuticals may pay billions of dollars in criminal penalties, fines, and lawsuit settlements. Allow us to help you secure what is owed to you.
Kennedy Hodges, LLP has helped individuals who have suffered serious injury due to prescription and pharmacy errors for over fifteen years. Take advantage of our experience and skills by calling us.