A shocking report from CNN suggests that Nuplazid, a drug approved by the U.S. Food and Drug Administration (FDA) to treat hallucinations, psychosis symptoms, and delusions linked to Parkinson’s disease may be linked to hundreds of adverse events. According to data obtained by CNN from the FDA and the Institute for Safe Medicine Practices (ISMP), even though Nuplazid, known generically as pimavanserin, was only approved for the market two years ago, hundreds of Nuplazid side effects have been reported since that time.
Among those reported side effects is a risk of death, continued hallucinations, falls, and nausea.
ISMP: Nuplazid Approval Based on “Limited Scientific Evidence”
A report from the Institute for Safe Medicine Practices (ISMP, November 1, 2017) shows the institute’s concerns about Nuplazid (pimavanserin). In its Quarterly Report, the ISMP states that Nuplazid approval was based “on limited scientific evidence that its benefits outweighed its risks.” Furthermore, the ISMP notes that Nuplazid approval relied on one clinical trial that showed a minimal effect, but that one positive trial came after three other trials found no benefit.
The ISMP also expressed concern that an FDA medical reviewer recommended not approving Nuplazid for Parkinson’s treatment but that his concerns were overruled. This despite reported evidence that the use of Nuplazid treatment doubled the risk of serious adverse events and/or death.
According to the ISMP’s report, the most frequently reported events linked to Nuplazid included hallucinations, the drug being ineffective, confusional state, and death. Acadia Pharmaceuticals, the maker of Nuplazid, responded to the ISMP report by saying the reports of hallucinations might have been made before the drug was fully effective, which typically occurs about four weeks into treatment. The company also noted Nuplazid is distributed through specialty pharmacies, which may make it more likely that adverse event reports are submitted to the FDA.
Desperate Patients Turned to Nuplazid Medication
In June 2016, the drug became available and many patients and their loved ones turned to Nuplazid to treat Parkinson’s delusions, hallucinations, and psychosis. In all, from the time the drug was released on the market to March 2017, the FDA received reports of 244 deaths linked to Nuplazid. Although this does not mean Nuplazid caused the adverse event, information received from these reports can be used by the FDA to review whether a drug needs stronger labels or should be pulled from the market.
FDA Voted 12-2 to Approve Nuplazid Drug
The FDA advisory committee voted 12-2 to approve Nuplazid, but that approval came based on a six-week study that included approximately 200 patients. Dr. Paul Andreason, the lead reviewer investigating Nuplazid, said he was not convinced the benefits outweighed the risks, especially given that studies showed serious adverse events occurred at more than two times the rate of those linked to a placebo.
Some experts, meanwhile, have expressed concerns that the study that received the positive outcome did so only after the drugmaker changed how it measured the drug’s effectiveness.
Brendan Tyne, who urged the FDA advisory panel to approve the drug for patients who were in desperate need of help—similar to his mother—said after she started taking Nuplazid she went “straight downhill to the point she really can’t function at all.”
For its part, the FDA has said it will continue to monitor Nuplazid and its risk/benefit profile, but it is currently not considering changing the drug’s label or approval. Meanwhile, Acadia is reportedly moving ahead with plans to get the medication approved for a larger population. That has some experts concerned about exposing a larger population to a wider range of side effects.
If you or someone you love suffered adverse events after using Nuplazid, contact a Nuplazid attorney at Cutter Law. Our attorneys specialize in helping people like you obtain the compensation they’re entitled to and can explain your legal options. We represent clients nationwide against pharmaceutical companies. Contact us for a no-obligation consultation today.