Nuplazid, a medication indicated to treat hallucinations and psychosis sometimes experienced by Parkinson’s disease patients, has been linked to thousands of adverse events, including deaths, life-threatening incidents, falls, insomnia, nausea, and fatigue.
Reports indicate that hundreds of people also continued to experience hallucinations while taking Nuplazid.
You may be eligible to file a Nuplazid lawsuit if you suffered serious side effects while taking this medication or lost a loved one as a result of this drug. To contact a Nuplazid lawyer today, please call (888) 994-5118.
Nuplazid (pimavanserin) is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. An estimated 1 million Americans suffer from Parkinson’s disease, with up to 50% experiencing delusions or hallucinations during the course of their illness.
Nuplazid works by blocking the serotonin receptors (5-HT2A) that may contribute to hallucinations. However, these same receptors also play a central role in learning, memory, and cognition. Thus, blocking their normal signaling has the potential to cause serious adverse events.
Following the U.S. Food & Drug Administration (FDA) approval of Nuplazid in April 2016., sales of the drug climbed to roughly $125 million in 2017. Acadia Pharmaceuticals expects Nuplazid sales will at least double in 2018.
Nuplazid can cost nearly $100 a day and as much as $30,000 per year for a single patient.
Nuplazid was granted breakthrough therapy designation by the FDA for the treatment of hallucinations and delusions associated with Parkinson’s disease. According to the agency, this program is “designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.”
The FDA’s approval of Nuplazid was based on a single 6-week study involving roughly 200 patients. Three previous Nuplazid clinical trials had failed to demonstrate a benefit in reducing hallucinations and other symptoms of psychosis.
Before it came to market, an FDA advisory panel voted 12-2 to recommend approval of Nuplazid. The head of the panel Dr. Paul Andreason indicated that Acadia’s limited studies left him unconvinced that Nuplazid’s benefits outweighed its risks. Among other things, Dr. Andreason noted that, in its only positive study, patients taking Nuplazid had double the risk of death and other serious adverse events compared to those taking a placebo.
According to CNN, other panel members who voted to approve Nuplazid expressed doubts, with one admitting he would not have voted “yes” if there had been a safe and effective alternative on the market.
“I guess I’m hoping that the 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 by this, I think they’re probably willing to take that risk,” another physician said.
A third urged 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.”
In November 2017, an analysis conducted by the Institute for Safe Medication Practices (ISMP) indicated that the FDA’s adverse event databased had received 2,236 Nuplazid reports within a single 12-month period ending March 2017.
The most frequently reported Nuplazid side effect included:
“The overall message in these adverse event reports is that hundreds of health professionals are trying this new drug with their patients and reporting that either it is not providing the expected benefit or making some psychosis worse,” the ISMP report concluded. “The large number of deaths also remains a concern in a setting where increased mortality was at least suspected if not proven in the clinical trials.”
Victims of alleged Nuplazid side effects may be entitled to compensation for medical bills, lost wages, pain and suffering, and more. Please call (888) 994-5118 to arrange for a free, no-obligation review of your potential Nuplazid lawsuit.
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