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Parkinson’s Disease is a devastating illness. Individuals living with the condition experience a degree of hallucinations, delusions and paranoia, encompassing severe visual and auditory distortions. In the meantime, loved ones have to contend with extreme episodes and watch their family member’s health greatly deteriorate.

For these reasons, doctors and patients welcomed Nuplazid (pimavanserin) to the market in 2016, believing this atypical antipsychotic would keep these severe symptoms under control. Yet – likely because of the FDA’s quick-approval process and limited research – extreme side effects, a condition that worsens and a concerningly high death rate have placed a microscope on this supposed “miracle drug.” In response, researchers, doctors and investigators have uncovered loopholes causing this under-tested drug to end up on the market and have highlighted extremely alarming statistics from Nuplazid’s first two years.

Background

Roughly 1 million Americans live with Parkinson’s, half experiencing some kind of psychotic side effect. Until Nuplazid’s introduction, no drug directly addressed these symptoms. Its supposed innovation led to quick approval through the FDA’s “breakthrough therapy” process. Specifically, if patients show significant improvement while taking an advanced drug, the FDA reduces the number of channels involved in approval. Since Congress’ 2012 motion to speed up how the FDA approves its drugs, a process criticized for its slow, years-long progression, 200 such medications have been designated as “breakthrough therapies.”

Attesting to the process’ speed, the FDA approved Nuplazid on a single six-week clinical trial with 199 participants. Results revealed patients saw the frequency and severity of their hallucinations decline without a negative impact on motor skills. During its first year, Nuplazid earned manufacturer Acadia $125 million in sales.

However, even during the approval process, researchers raised objections, including Dr. Andreason, who claimed:

  • Nuplazid offered minimal hallucination control during the clinical trials.
  • Compared to the placebo group, the Nuplazid pool had twice the number of patient deaths.
  • Three previous trials had the same finding and risk makeup.

Along with these observations, other researchers expressed reservations about pushing Nuplazid so quickly, instead believing the drug needed additional testing.

Reflecting these results, the FDA soon started receiving adverse event reports concerning the drug’s side effects, including:

  • More hallucinations
  • A constant state of confusion or disorientation
  • Falls
  • Nausea
  • Fatigue

Even more concerning, Nuplazid was the subject of 244 patient death reports from June 2016 through March 2017. Over the past year, these figures have only continued to grow: over 5,000 concerning adverse, life-threatening incidents and 700 involving patient death.

Regarding these findings, Acadia released a statement attributing the high number of patient deaths to Nuplazid’s targeted population, explaining those living with Parkinson’s already have a high death risk. Acadia further stated that purchasing pharmacies skewed statistics, explaining that such entities have more direct contact with patients. Supporting their assertions, Acadia cited two studies claiming Nuplazid’s death rate was no different from patients who took a placebo and explained that, compared to the general Medicare population living with Parkinson’s psychosis, those taking Nuplazid have lower death rates.

Amplifying these ongoing issues, a 2018 CNN report quoted geriatric psychiatrist and former FDA medical officer Susan Molchan, who claims Nuplazid’s high number of deaths is alarming and further asserted that patients and their families may not be aware of the drug’s full risks. CNN also produced its own data analysis, examining several hundred adverse reports. While the death rates remain high, unclear data doesn’t establish a cause-and-effect relationship:

  • Doctors who prescribed Nuplazid occasionally attribute a patient’s death to complications from Parkinson’s, rather than the drug.
  • Reports don’t always indicate if a patient used the drug up until the time of death.
  • The only association comes from doctors and family members, who claim the patient’s condition changed while taking Nuplazid.

While the drug carries a black box warning, the FDA has yet to issue a recall, claiming Nuplazid’s risks outweigh the benefits.

As of 2018, Acadia has announced plans to expand Nuplazid’s scope and has been conducing clinical trials involving patients with dementia-related psychosis – an off-label usage certain doctors already support. The FDA has also given its “breakthrough therapy” approval for this study.

Lawsuits

While Acadia advertised Nuplazid as a miracle drug for managing Parkinson’s most severe symptoms, patients and family members have found mostly disappointment. Symptoms worsen, a loved one’s demeanor completely changes and early death comes on suddenly with little to no warning. If you or a loved one experienced any of these symptoms, it’s time to hold drug manufacturers accountable for negligence in clinical trials and inaccurate advertisements. To bring your claim to Trantolo & Trantolo’s attention, contact us today to speak with a dangerous drug lawyer.