Possible side effects of Nuplazid treatment for Parkinson’s-related psychosis may include worsened hallucinations or delusions or even wrongful death.
For many Parkinson’s patients and loved ones who were desperate for a reprieve from psychosis, hallucinations and delusions associated with the advanced stages of the disease, the FDA’s approval of Nuplazid in April 2016 seemed like a light at the end of the tunnel. Just two years after its approval, however, the FDA has received reports of as many as 700 patient deaths among Nuplazid patients, and in the short time it has been on the market, the drug has not only not provided the expected benefit for patients with Parkinson’s-related psychosis, it has worsened the condition in some. If your loved one took Nuplazid as a treatment for psychosis related to Parkinson’s disease, and he or she has suffered worsened hallucinations, delusions or death, contact the Consumer Justice Foundation today for help. Our consumer advocates are committed to protecting the rights of patients harmed by defective medications and can help put you in touch with a knowledgeable Nuplazid injury lawyer.
In the short time it has been on the market, Nuplazid has been named in thousands of adverse event reports submitted to the FDA, including reports of more than 700 patient deaths. Unfortunately, because other antipsychotics used to treat Parkinson’s patients also come with an increased risk of death, family members of patients with Parkinson’s don’t have a lot of options. They may choose Nuplazid knowing that while it may improve their loved one’s quality of life, it may also shorten their life expectancy. Some patients suffering from psychosis related to Parkinson’s disease may turn to alternative treatments to avoid the risk of death and other potential side effects from Nuplazid. Some possible Nuplazid alternatives for psychosis and hallucinations include:
A medication approved to treat psychosis, hallucinations and delusions in patients with Parkinson’s disease that has been linked to more than 700 cases of patient death.
Nuplazid (pimavanserin) is a new kind of antipsychotic medication used to relieve symptoms of psychosis in patients with Parkinson’s disease. Nuplazid is manufactured by San Diego-based Acadia Pharmaceuticals and was approved by the FDA in April 2016, an approval that was expedited because the drug was considered a “breakthrough therapy,” believed to demonstrate a “substantial improvement” over other available treatments for Parkinson’s patients. The medication was designed to temporarily reduce mental disturbances associated with Parkinson’s disease, which it does by blocking normal signaling with the serotonin receptors (5-HT2A) that may contribute to hallucinations, and was considered an experimental treatment at the time it was approved. Psychosis, hallucinations and delusions are symptoms typically seen in patients in the most advanced stages of Parkinson’s disease, which means they are already at a high risk of death, which is one reason it took so long for people to realize that treatment with Nuplazid may be contributing to these reports of patient deaths.
Within two years of Nuplazid’s approval by the FDA, healthcare professionals and patients’ family members began reporting adverse events they believed to be linked to the Parkinson’s drug, including falls, insomnia and patient deaths. In more than 1,000 of these reports, Parkinson’s patients continued to experience hallucinations while taking the medication, and some experienced worsened hallucinations on Nuplazid. Among the possible side effects leading to a Nuplazid lawsuit are:
In November 2017, the Institute for Safe Medication Practices (ISMP) published its QuarterWatch report, which noted that Nuplazid had been linked to as many as 244 patient deaths in adverse event reports submitted to the FDA from the time the medication was approved in April 2016 to March 2017, less than one year later. According to the ISMP report, Nuplazid’s approval by the FDA was based on severely limited scientific evidence gleaned from one six-week clinical trial that showed a minimal treatment effect among about 200 patients taking Nuplazid. Prior to that study, three previous Nuplazid trials failed to demonstrate any treatment benefit at all. In fact, according to the QuarterWatch report, further analysis of the effects of Nuplazid on patients experiencing Parkinson’s-related hallucinations suggested that the medication was likely making the hallucinations worse, not better.
Since the ISMP issued its report in late 2017, the FDA has reported that that number of patient deaths associated with Nuplazid treatment has skyrocketed to more than 700. Says Diana Zuckerman, founder and president of the nonprofit thinktank, the National Center for Health Research, “This is almost unheard of, to have this many deaths reported. You just don’t see this with most new drugs – you don’t see all these reports – so you have to take it seriously.” Even more alarming, because the adverse event reports submitted to the FDA are voluntary, there may be many more deaths and other serious side effects from Nuplazid treatment that haven’t been reported. After analyzing the adverse event data for the Parkinson’s drug, the ISMP concluded that this new information about potential Nuplazid side effects “reinforces the concerns of those who warned that (Nuplazid) might do more harm than good.”
You may be eligible to file a Nuplazid lawsuit against Acadia Pharmaceuticals if your loved one suffered serious side effects or death while taking the Parkinson’s disease drug. Product liability lawyers are currently investigating Nuplazid injury claims filed on behalf of patients and their family members across the country who believe they have been harmed by the medication. By hiring a drug injury lawyer and filing a Nuplazid lawsuit, you and your loved one may be able to pursue financial compensation for medical bills, pain and suffering, lost wages, emotional trauma and other damages.
April 2016 – The FDA approves Nuplazid, the first drug to treat hallucinations and delusions associated with Parkinson’s disease.
April 2016 – Nuplazid carries a boxed warning notifying patients and doctors about an increased risk of death associated with Nuplazid treatment in older people with dementia-related psychosis.
December 2017 – As of December 2017, Nuplazid treatment has been linked to 1,860 cases of serious adverse events reported to the FDA, including 712 deaths.
April 2018 – The FDA reports that it will re-examine the safety of Nuplazid in light of new evidence that the medication may cause serious adverse events or death in patients.
November 2012 – A six-week clinical trial is conducted involving 199 patients taking Nuplazid for Parkinson’s-related psychosis. This trial ultimately leads to the FDA’s approval of Nuplazid.
November 2017 – The Institute for Safe Medication Practices publishes its QuarterWatch report identifying at least 244 patient deaths associated with Nuplazid treatment, plus other adverse events, like hallucinations, confused state and a lack of treatment benefit.
April 2018 – CNN publishes an article linking Nuplazid treatment to more than 700 patient deaths in just two years.
In CNN’s scathing Nuplazid report, medical researchers, physicians and other experts voiced concerns that Nuplazid’s approval by the FDA was rushed and based on too little evidence that the medication was safe or effective. Despite these concerns, the FDA’s position on the safety of the drug for the most part remains unchanged. For its part, Acadia Pharmaceuticals maintains that Nuplazid helps fill a desperate need for Parkinson’s patients and their loved ones and that the benefits of the drug ultimately outweigh the risks. Not only is Acadia defending the safety of Nuplazid for the treatment of psychosis in Parkinson’s patients, the company is moving forward with clinical trials in an attempt to get the drug approved for use in a larger patient population, for patients with dementia-related psychosis. “You would certainly hope they don’t approve it for anything else,” says Zuckerman of the National Center for Health Research. “If they’re going to approve it for another group of patients that is much, much larger – that would be unconscionable.”
More than 700 Parkinson’s patients have died while taking Nuplazid and hundreds more have experienced worsened hallucinations or no treatment benefit at all on the drug. Yet, the FDA refuses to issue new warnings about this potential treatment risk, and Acadia Pharmaceuticals is actually trying to get additional approval for Nuplazid as a treatment for patients with dementia-related psychosis, even though the drug currently carries a boxed warning regarding the increased risk of death for this exact patient population. According to reports, psychosis occurs in up to 50% of all patients with Parkinson’s disease, which affects roughly one million Americans, and Nuplazid is the first medication to be approved as a treatment for this condition. Sadly, many family members of Parkinson’s patients who thought the medication would relieve their loved one’s hallucinations and delusions rushed to get them on the drug when it first hit the market, and are now discovering that the treatment may have actually put them at a greater risk of death or worsened symptoms. If your loved one died while taking Nuplazid, or suffered worsened hallucinations or other adverse events, our consumer advocates at Consumer Justice Foundation can help. Contact us today to speak to an experienced Nuplazid injury lawyer about your claim.