Risperdal is the trade name for the antipsychotic drug risperidone, an atypical antipsychotic medication that was approved by the FDA in 1993 to help treat some symptoms of psychiatric disorders, including schizophrenia, the manic phase of bipolar disorder, and some symptoms of autism. Unfortunately, Risperdal’s manufacturer, Johnson & Johnson, marketed the drug for purposes that were not approved by the FDA, exposing numerous patients to severe and even deadly side effects. In response to these tactics, some users of Risperdal, and users of two other drugs manufactured and marketed by Johnson & Johnson, have taken legal action against the company.
Risperdal Side Effects
Risperidone has some notable side effects that could affect any user of the medication. These include, but are not limited to: weight gain, the development of metabolic problems like type 2 diabetes, and the development of conditions like tardive dyskinesia or neuroleptic malignant syndrome. While all of these side effects have the potential to affect users’ lives in significant ways, unfortunately, there are additional serious side effects that can affect elderly people and children who are prescribed this medication. In addition to marketing Risperdal to elderly patients before securing FDA approval, Johnson & Johnson also marketed Risperdal to children before they were allowed to do so by the FDA, and some users, specifically male children, suffered as a result of using this drug.
Because use of Risperdal increases the hormone prolactin in users, young boys who used this medication experienced male breast growth, or gynecomastia. While gynecomastia involves the benign grown of male breast tissue, the process of countering the effects of gynecomastia can be invasive. While some boys who suffer from male breast growth may have the effects reversed through liposuction, others will have to undergo a mastectomy in order to reverse the effects.
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Johnson & Johnson has been accused of improperly marketing Risperdal to older adults, children, and individuals with developmental disabilities before the FDA approved the drug to be marketed to these individuals. As a result, the company may have placed the lives and health of many of its consumers in grave danger. If you or someone you love has suffered from the side effects of Risperdal, we know that there is nothing that can be done to erase the pain and suffering that you have been forced to undergo. However, it may be possible for you to secure compensation from Johnson & Johnson for your resulting losses.
If you are considering taking legal action against Johnson & Johnson, however, you do not have unlimited time in which to file a claim. Individuals harmed by a defective drug have a very small window in which they can take legal action, so it is important to contact an attorney as quickly as possible.
At the National Injury Law Center, we have years of experience taking on large pharmaceutical companies, and we are ready to put our experience to work helping you and your family. Call us today at 888-273-6041 to learn more about what our team can do for you.
The active ingredient in Risperdal is risperidone, just one drug in a class of antipsychotics that act on several different receptors in the brain, including dopamine, serotonin, and histamine h1 receptors to help treat some of the symptoms of certain psychiatric disorders. It is approved to help treat manic or mixed episodes associated with bipolar disorder, irritability associated with autism, and schizophrenia. Even though the FDA did not approve the use of Risperdal for elderly patients, the drug was still marketed to these individuals, and many suffered serious side effects. Specifically, it has been shown that use of Risperdal can increase the risk of mortality and the risk of strokes in patients with dementia.
Risperdal and the FDA
The FDA first approved Risperdal in 1993 to treat symptoms of psychiatric disorders. However, in 2005, the FDA came out and said that the results of clinical trials suggested that atypical antipsychotic medications greatly increased the risk of death for elderly individuals with dementia-related psychosis. As a result, Risperdal and a number of other drugs were required to display the FDA’s Black Box warning, the strongest warning they have, on the drug’s box. This warning clearly states that Risperdal is NOT approved to treat patients suffering from dementia-related psychosis. According to a study performed by the FDA in which patients with dementia were treated with a placebo while others were given an atypical antipsychotic, individuals who received the antipsychotic medication were 1.6 to 1.7 times more likely to die than patients who were given the placebo. In most cases, the cause of death was cardiovascular or infectious in nature.
History of Risperdal
A subsidiary of Johnson & Johnson, Janssen-Cilag, developed Risperdal from 1988-1992 hoping it could serve as an alternative to typical antipsychotic medications, and the medication was first approved by the FDA in 1993 for use in treating irritability in patients with schizophrenia. Quickly, Risperdal became incredibly profitable, and by 1996, there were over a million prescriptions for the drug. In 2001, a report in the Miami Herald reported that there had been reports of severe side effects when Risperdal had been given to “unruly” juveniles living in foster homes in Florida. One year later, Janssen Pharmaceuticals issued a letter to doctors in Canada discussing the potential risks associated with giving Risperdal to elderly patients suffering from dementia.
In 2003, Janssen sent a similar letter to doctors in the United States. It was in this same year that Risperdal was approved for the treatment of patients with bipolar disorder. Because of the serious risks associated with prescribing Risperdal to elderly dementia patients, in 2005 the FDA required Risperdal to carry a black box warning on its label, articulating the increased risk of mortality that the drug posted to these users. One year later, the drug was first approved for use in children for certain uses. Risperdal has never been approved by the FDA for use in elderly patients suffering from dementia, and was only approved for use in children in 2006, but a recent lawsuit from the Department of Justice against Johnson & Johnson alleges that the company marketed the drug, along with two other drugs (Invega and Natrecor), for uses unapproved by the FDA. Johnson & Johnson agreed to plead guilty to criminal misdemeanor charges and settle the suit for $2.2 billion, making it the third largest pharmaceutical settlement in U.S. history.
Contact an Attorney
If You Have Suffered from Risperdal If you have suffered serious side effects after taking Risperdal, or if you have lost a loved one who took this drug, you should not be forced to cover the resulting losses on your own. Pharmaceutical companies that jeopardize patients’ health and well-being in the name of making a profit need to be held accountable for the effects of their decisions, and a lawsuit is one of the best ways to pursue justice and fight for the compensation you and your family needs. However, you do not have unlimited time to file a lawsuit. As such, if you have suffered any losses because of Risperdal use, take action today and contact an experienced attorney at the National Injury Law Center today at 888-273-6041. You need experienced legal help on your side before you go up against a large pharmaceutical company, and at the National Injury Law Center, we have the experience, resources, and understanding you need on your side.