The FDA approved Nuplazid (pimaveanserin) in 2016 as an antipsychotic drug. Nuplazid is alleged by its maker to treat hallucinations, delusions, and other symptoms of psychosis among Parkinson’s disease victims. But Nuplazid may not work as advertised. Many people taking the drug continue to experience hallucinations, and Nuplazid has been linked with hundreds of deaths, though it is uncertain how many may have been caused by the drug. Our law firm is investigating a potential Nuplazid Lawsuit against the drug’s maker.
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Matthews & Associates Law Firm is investigating Nuplazid injury cases. If you believe that you or someone you love was injured by Nuplazid, contact our law firm for a free legal consultation regarding a potential Nuplazid lawsuit against the drug’s maker.
A Nuplazid report published November 1, 2017 by the Institute for Safe Medication Practices (ISMP) QuarterWatch has raised serious concerns about the safety of Nuplazid. CNN also covered Nuplazid problems in an April 2018 story titled: “FDA worried drug was risky; now reports of deaths spark concern.”
FDA approves Nuplazid
The CNN story partially investigated an FDA Advisory Committee recommendation of approval for Nuplazid in March 2016. That CNN piece showed how easily the FDA can be moved to approve a new drug despite alack of evidence to prove any benefit outweighs the drug’s risks:
The committee voted 12-2 to recommend the FDA approve Nuplazid for the treatment of Parkinson’s disease psychosis. The majority apparently based their view on a mere six-week study of about 200 patients, because three previous studies had failed to show Nuplazid was effective.
According to the transcript, even some committee members who voted in favor of Nuplazid expressed their doubts about its safety and efficacy.
One doctor apparently voted on ‘hope’ alone, stating, “I guess I’m hoping (risks) are going to be small, and I think the benefits for some of these people who are very sick and whose families are affected, [I] think they’re probably willing to take that risk.” One can fairly ask whether those families knew the actual risks the doctor spoke of, and whether the risk of death justified the risk of taking Nuplazid.
Another majority voter claimed she wouldn’t have voted for Nuplazid’s approval if there had been a safe and effective alternative on the market. A third majority voter reportedly made a “plea” to the FDA to “consider a large observational study so we can ensure that, once it goes into real-world use, that the benefits will outweigh the risks.”
Approved by the FDA in April 2016, Nuplazid became available to US patients in June 2016. The drug may have been approved much too easily simply because hundreds of thousands of people are reportedly stricken with Parkinson’s. The disease typically strikes people around age 65, but the actor Michael J. Fox and many others have been diagnosed with Parkinson’s at much younger ages, bringing the problem into the public spotlight.
Nuplazid and Deaths, Falls, Insomnia, Nausea, Fatigue
CNN’s April 2018 news story noted that shortly after Nuplazid’s release, patients’ family members, doctors and other health care professionals began reporting “adverse events” possibly linked to Nuplazid. Those “events” included deaths, life-threatening incidents, falls, insomnia, nausea and fatigue. More than 1,000 Nuplazid adverse event reports said patients continued to experience hallucinations while on the drug.
244 Nuplazid Deaths Reported
In November 2017, the non-profit Institute for Safe Medication Practices warned that 244 deaths had been reported to the FDA between Nuplazid’s launch and March 2017. The ISMP also noted that hundreds of reports suggested Nuplazid was “not providing the expected benefit” or was even worsening conditions for Parkinson’s sufferers.
700 Nuplazid Deaths
Since ISMP released its analysis, FDA data shows reported Nuplazid-linked deaths have risen to more than 700. As of June 2017, Nuplazid was the only medication listed as “suspect” in at least 500 of the death reports.
Black-Box Warning – Increased Death Risk
Is the company that makes Nuplazid off the hook for liability because it has already added a black-box death warning to Nuplazid? Maybe and maybe not.
Nuplazid’s warning included the caveat that elderly patients with dementia-related psychosis treated with anti-psychotic drugs are at an increased risk of death.
The drug’s label also states that Nuplazid is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis [Warnings and Precautions 5.1].
A Drug Company’s Responsibility
When faced with the results of its own study, a drug company has a responsibility to conduct more studies, rather than moving the product to market as fast as possible. When faced with the reported adverse events after a product is on the market, a diligent company needs to remove this product from the market. There does not appear to be much evidence of efficacy for Nuplazid, and a lot of evidence of risks not warned about on the drug’s label suggest Nuplazid should not even be on the market. The sheer numbers of reported deaths should be prompting this company to take appropriate actions and take the product off the market.
CNN’s April 2018 news story included an expert’s comment on the shocking number of deaths:
Diana Zuckerman, founder and president of the nonprofit think tank the National Center for Health Research, said it was “almost unheard of to have this many deaths reported.” And so this is what we’ve come to, that hundreds of deaths linked to a drug on the market for just two years is only “almost unheard of”?
“You just don’t see this with most new drugs, said Ms. Zuckerman. “You don’t see all these reports, so you have to take it seriously.”
Are patients and their families aware of the risks associated with Nuplazid?
We are investigating Nuplazid injuries and deaths for potential litigation. If you believe that you or someone you love was injured as a result of taking Nuplazid, contact us for a free legal consultation regarding a potential Nuplazid lawsuit against the maker of this drug.