Nuplazid (pimavanserin) is a relatively new drug approved to treat patients with Parkinson’s disease who suffer delusions, psychosis symptoms and hallucinations. Since it was approved for the market, however, an astonishing number of patients have suffered serious adverse events—including death and life-threatening events—while other patients say they did not obtain the benefits they expected.
Attorneys are now investigating possible Nuplazid lawsuits, alleging patients were put at serious, unnecessary risk of adverse events.
Nuplazid Parkinson’s Treatment
Nuplazid, known generically as pimavanserin, is made by Acadia Pharmaceuticals and meant to treat Parkinson’s patients who suffer delusions, hallucinations, and psychosis symptoms. Despite being on the market fewer than two years, however, Nuplazid has been the source of hundreds of complaints to the FDA.
Meanwhile, a review by the Institute for Safe Medicine Practices (ISMP), suggests that patients suffered serious, life-threatening Nuplazid side effects.
The report found that in the 12 months ending in March 2017, there were 2236 reports made about Nuplazid. The most frequently reported side effects included:
- Hallucinations (487 reports)
- Drug ineffectiveness (333 reports)
- Confusional state (258 reports)
- Death (244 reports)
In some cases, according to the ISMP, there were signs Nuplazid made the patient’s psychosis worse.
According to a report by CNN, the FDA’s data suggests the number of reported deaths sits at more than 700.
Nuplazid FDA Approval for Parkinson’s Drug
One of the main issues is the process by which Nuplazid approval was obtained. The Nuplazid drug was considered a “breakthrough therapy,” a designation given to drugs that show substantial improvement in patients who suffer serious diseases, especially when compared with drugs already on the market.
After a six-week study that involved around 200 patients, the FDA’s advisory committee voted 12-2 to recommend that the administration approve Nuplazid for Parkinson’s hallucinations. In June 2016, Nuplazid was released on the market. The ISMP, however, noted that that pimavanserin was approved based on “limited scientific evidence that its benefits outweighed its risks.”
One of the FDA physicians who reviewed Nuplazid warned the agency that serious Nuplazid side effects, including death, happened more than twice as often in people taking the medication than those given a placebo. Dr. Paul Andreason said he was not convinced the benefits of Nuplazid Parkinson’s treatment outweighed the risks.
Nuplazid Side Effects
Among the side effects or adverse events reportedly experienced by patients who took Nuplazid medication:
- Hallucinations (not properly treated with Nuplazid)
These Nuplazid side effects are especially concerning given that many patients report they have not received the benefits they expected from the drug. This suggests patients may be put at an unnecessary risk of side effects without receiving any positive effects of the medication.
Patients took Nuplazid believing they were taking a medication whose benefits outweighed the risks. Many patients, however, reportedly discovered they could be at an increased risk of serious side effects.
If you or a loved one was harmed by the use of Nuplazid (pimavanserin), contact a personal injury lawyer at Patterson Dahlberg today.
Our attorneys are highly skilled at investigating claims against pharmaceutical companies and advocating for the rights of our clients.
We’ve recovered more than $120 million on behalf of our personal injury clients, including clients who have been harmed by medications.
We’re known for providing compassionate, expert legal counsel to our clients, and are experienced at complex litigation.
We can help you determine your legal options and advise you as to whether a Nuplazid lawsuit is right for you. Contact a Nuplazid attorney at Patterson Dahlberg Injury Lawyers today.