Nuplazid (pimavanserin) is a medication used to treat psychosis and hallucinogenic symptoms associated with Parkinson’s disease. It has been linked to serious side effects such as an increase in Parkinson-related symptoms and death and some in the medical community are beginning to question the efficacy of the drug.
Nuplazid side effects include:
- Increased hallucinations or psychosis
- Delusional thinking
Nuplazid & Parkinson’s Disease
Nearly one million people in the United States are diagnosed with Parkinson’s disease. Mostly aged 65 years and older, it is a movement disorder that involves the rapid decrease of dopamine-producing neurons. The American Parkinson Disease Association indicates nearly half of those diagnosed with Parkinson’s will eventually develop hallucinations.
Nuplazid is a fairly new prescription medication to the biochemical market. It is used to lessen the devastating symptoms of living with Parkinson’s disease. Nuplazid generated quite a bit of hype from the public as a treatment for hallucinations and psychosis. Due to this, it received a swift launch onto the market through FDA clearance.
Was Nuplazid Approved by FDA Too Quickly?
Nuplazid was introduced by Acadia Pharmaceuticals, based out of San Diego, as a “breakthrough therapy” and was quickly rushed through FDA approval process. Breakthrough therapy is a process that expedites the review and development of drugs that show “substantial improvement” on the condition for which it is intended to treat in comparison to those already on the market. Inevitably, to receive clearance for market approval, the end result of breakthrough therapy is that the benefits outweigh the risks.
Doctors Warned FDA of Nuplazid Side Effects Prior to Approval
Dr. Paul Andreason, the lead physician on the FDA medical review committee, was not convinced of the latter.
The Nuplazid phase in review by the FDA was only a six-week study of roughly 200 patients. Based off the results, Andreason warned the side effects of Nuplazid increased twofold compared to patients taking the placebo during clinical trials.
Despite warnings from members of the Food and Drug Administration medical review board, Nuplazid was approved to treat Parkinson’s related psychosis in a 12-2 vote. It hit the consumer market in June 2016. Over a year after its release, Nuplazid generated $125 million in sales for Acadia Pharmaceuticals in 2017.
Increase of Adverse Events Begin to Surface
After the release of Nuplazid to the U.S. market, physicians, family members and other various healthcare professionals reported an increase in adverse events of newly prescribed patients using Nuplazid.
In November 2017, a report issued by the non-profit Institute for Safe Medication Practices, indicated over 2,200 patients had experienced a worsening of side effects from taking Nuplazid. The report was conducted over a 12-month period, ending in March 2017 and included 244 deaths.
Acadia Pharmaceuticals Defends Nuplazid
The findings were shared with the manufacturer of Nuplazid, Acadia Pharmaceuticals, who countered the evaluation by suggesting the increased reports in adverse effects was due to frequent contact with users of the medication.
In fact, the manufacturer of Nuplazid recently issued a statement defending Nuplazid and the recent correlation between their drug and the reported increased risk of serious side effects and/or death. Click the following link to read more: ACADIA Statement on Efficacy and Safety of NUPLAZID
Nuplazid Linked to Worsening Psychosis / Hallucinations
The ISMP report said, “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.”
Brendan Tyne was an advocate for pushing Nuplazid towards consumer use. His mother had been living with the debilitating effects of Parkinson’s and he was hopeful the new drug would bring her a sense of peace as she entered in the later stages of her disease. He desperately wanted his children to experience the once-loving nature of their grandmother who fell victim to the devastating effects of Parkinson’s.
He issued a statement to the FDA advisory committee during the early stages of Nuplazid review, prior to market approval. “If nothing is done to bring her back to some semblance of normalcy,” he said, “my children will never remember their grandmother for who she is: a loving, funny, caring woman who has improved the lives of all of the loved ones who surround her.”
In a later interview with CNN, Tyne regretfully recounted an update on his mother’s condition post-Nuplazid treatment. He said,
“She has gone straight downhill to the point she really can’t function at all.” Tyne indicated a correlation of increased Nuplazid induced hallucinations, identical to the findings the ISMP had found.