- Category: Side Effects Lawsuit
Risperdal Side Effects Lawsuit
Risperdal Side Effects Lawsuit
On September 22, 2011, an FDA advisory panel acknowledged that Risperdal and similar antipsychotics put children using these drugs at the increased risk of diabetes and severe weight gain. It recommended continued safety monitoring of Risperdal and admitted that Risperdal could cause potential long-term health problems in children. The expert panel also urged the FDA to carry out in-depth studies on these Risperdal side effects. It also sought label warnings on Risperdal, highlighting the risks.
Risperdal, known by its generic name risperidone, is manufactured by Janssen Pharmaceutica, a Johnson & Johnson subsidiary. The FDA approved this second generation antipsychotic in 1994 as a medication for schizophrenia, bipolar disorder symptoms, psychoses, and manic depression. Risperdal is also prescribed to treat irritability in people with autism and a number of psychological disorders. However, Risperdal has been linked to neuroleptic malignant syndrome, metabolic disorders, tardive dyskinesia, and death ofpatients suffering from dementia.
Risperdal FDA Warnings and Complaints
In February 2011, the FDA alerted healthcare professionals and consumers about the possible risk of abnormal muscle movements and health concerns in newborns due to side effects of Risperdal taken by pregnant women. The new warnings were added to the label to highlight the ability of Risperdal to cross the placenta and affect the fetus. The FDA has received more than 70 reports of neonatal extrapyramidal signs linked to Risperdal side effects. Health Canada issued a similar warning in June 2011 listing withdrawal symptoms, agitation, sleepiness, and breathing difficulties in addition to abnormal muscle tone and extrapyramidal signs in newborns as possible Risperdal side effects. It asked healthcare professionals to consider not prescribing Risperdal to pregnant women during the third trimester.
In June 2011, Johnson & Johnson recalled about 16,000 bottles of Risperdal following a consumer complaint about a musty odor emanating from the bottles. The investigation revealed that Risperdal was contaminated with tribromoanisole, a chemical used as pesticide. This followed a public health alert issued by the FDA about potential risk of medication error caused by confusion over Risperdal and GlaxoSmithKline’s Requip, a drug used for treatment of Parkinson’s disease. The FDA has received more than 225 reports of medication errors due to the confusion of similar name and packaging of the two drugs.
In May 2011, federal investigators found that illegal kickback schemes run by Johnson & Johnson led to Risperdal prescription to patients suffering from dementia at nursing homes across the state. Risperdal is not approved for dementia treatment and can result in the death of such patients. However, nursing homes were paid for prescribing Risperdal to dementia patients. The FDA has added black box warnings on atypical antipsychotics similar to Risperdal, prohibiting use for dementia patients.
A report published in the January 2011 issue of the Lancet journal warned against treating Alzheimer’s patients with Risperdal. The study conducted by researchers at the London-based Wolfson Centre for Age-Related Diseases claimed that Risperdal could double the risk of death of patients with moderate to severe Alzheimer’s disease. In 2006, a research report in the New England Journal of Medicine was the first to emphasize that Risperdal side effects could cause more harm than benefits when used by Alzheimer's patients.
Risperdal Side Effects
Nervous System Side Effects
Risperdal impacts the normal functioning of the nervous system and causes a number of neurological disorders, such as insomnia, muscle tone disorder, somnolence, restlessness, and extrapyramidal symptoms. Risperdal has also been linked to headache, dizziness, parkinsonism, abnormal loss of strength, and impaired concentration. Patients using Risperdal have experienced withdrawal syndrome, confusion, cholinergic syndrome, tardive dyskinesia, and tongue paralysis. The FDA has also received reports of sleep- related eating disorder and neuroleptic malignant syndrome linked to Risperdal.
Cardiovascular Side Effects
Risperdal side effects result in cardiovascular problems, including abnormally rapid heartbeat, hypertension, myocardial infarction, premature atrial contractions, syncope, venous thromboembolism, palpitation, and AV block. Post-marketing reports have also highlighted a number of cerebrovascular events, including stroke and related including fatalities, in elderly dementia patients due to Risperdal side effects.
Endocrine Side Effects
Risperdal has been linked to endocrine side effects, such as diabetes, increased prolactin level, and antidiuretic hormone disorders. Risperdal is also known to cause hyperprolactinemia, which is responsible for sexual dysfunction, menstrual irregularities, decreased fertility, and osteoporosis in patients. Rise in prolactin puts patients at the increased risk of breast cancers.
Gastrointestinal Side Effects
Constipation, digestive disorder, abdominal pain, gastritis, and hypersalivation are the most common Risperdal gastrointestinal side effects reported to the FDA. Patients treated with Risperdal also experience tooth ache and disorder, anorexia, tongue edema, gastric problem in the alimentary canal, stomatitis, hematemesis, and hemorrhoids.
Psychiatric Side Effects
Risperdal has also been linked to psychiatric problems in users, such as agitation, manic disorder, aggressive behavior, emotional liability, and anxiety. Patients treated with Risperdal therapy are also likely to suffer from depression, nightmares, catatonic reaction, euphoria, and obsessive-compulsive symptoms.
Respiratory Side Effects
Risperdal therapy causes common respiratory side effects, including upper respiratory infection, rhinitis, pharyngitis, pneumonia, and labored respiration. Risperdal has also been linked to stridor and sleep apnea. Rare respiratory side effects caused by Risperdal include asthma and respiratory dyskinesia.
Other Risperdal Side Effects
Ocular side effects, including abnormal vision, xerophthalmia, double vision, eye pain, eyelids inflammation, and photophobia.
Metabolic side effects, including glucose intolerance, weight gain, and altered insulin sensitivity.
Dermatologic side effects, including rash, photosensitivity, and skin pigmentation.
Musculoskeletal side effects, including joint pain, muscle pain and cramp, skeletal pain, and arthritis.
Hepatic side effects, including hepatic failure and cholestatic hepatitis.
In October 2010, a Louisiana court fined Johnson & Johnson $257.7 million in a Risperdal lawsuit for wrongful promotion of Risperdal. The pharma major was charged with fraudulent market practices and making misleading claims in its sales calls and promotional letters sent to 700,000 doctors across the United States in 2003. In March 2011, a federal judge permitted a whistleblower Risperdal lawsuit against Johnson & Johnson to proceed. The lawsuit backed by the Justice Department accuses the manufacturer of paying illegal kickbacks to nursing homes to increase Risperdal sales. Similar Risperdal Lawsuit have also filed in Arkansas and South Carolina, accusing Johnson & Johnson of wrongful marketing practices to promote Risperdal. A large number of patients, who have suffered due to Risperdal side effects, have filed personal injury Lawsuit seeking damages from the manufacturer.