The drug, Primavanserin (Nuplazid), is a relatively new antipsychotic drug. It is prescribed for the treatment of hallucinations, delusions and other symptoms of psychosis among patients with Parkinson’s disease.
Prior to its approval, family members of Parkinson’s patients were clamoring to get their hands on it. Hopes were high that Nuplazid would perform better than other antipsychotic medications.
Like many Americans, as much as you may have come to accept the inevitability of getting older, you probably don’t like noticing signs of aging such as wrinkles, vision loss, aching joints, fatigue and more.
But what most people — doctors included — don’t realize is these seemingly innocuous symptoms stem from a simple hidden cause that can easily be corrected.
But are the results living up to the hype?
Nuplazid Approval Based on Study That Showed Double the Risk of Death
The FDA approved Nuplazid using a single six week trial. It involved a meager 199 Parkinson’s patients…and only 95 of those patients received the drug. The remainder received a placebo.
At the end of the trial, the study concluded that yes, indeed Nuplazid reduced the frequency and severity of hallucinations and delusions.
The makers of Nuplazid must have been ecstatic. After three previously failed trials, they finally had one that showed a benefit. And it was enough get the FDA’s approval for the drug.
However, the study also showed something much more alarming. The trial revealed that treatment with Nuplazid more than doubled the risk of death and serious adverse events. Because of this, the FDA’s medical reviewer actually recommended against approving the drug. But he was overruled.
Despite these concerns, the FDA approved Nuplazid. It hit the market in 2016, complete with a black box warning indicating an increased risk of death.
Recently, CNN followed up on the performance and adverse events associated with the drug. And what they learned is quite disturbing. They discovered that data from the FDA shows there are more than 700 patient deaths linked to Nuplazid.
Additionally, a November 2017 analysis from The Institute for Safe Medication Practices (ISMP) QuarterWatch scoured all adverse events associated with the drug. Not only was Nuplazid linked to patient deaths, it also appeared to be associated with worsening psychosis — an increased frequency of hallucinations and confusion. In other cases, the drug appeared to be ineffective altogether.
Weighing the Risks Against the Benefits
CNN reports that physicians, medical researchers and other experts told them they worried that the drug had been approved too quickly, based on too little evidence that it was safe or effective. The FDA, on the other hand, defends their position.
According to CNN, the agency notes that “…the cases reported so far typically involved elderly patients with advanced-stage Parkinson’s disease who suffer from numerous medical conditions and often take other medications that can increase the risk of death.”
The bottom line is that many pharmaceutical drugs are released to the public well before their long-term side effects are known. Many of these drugs are frantically recalled years later…when we finally learn that they come with a load of potentially deadly adverse events.
In the case of Nuplazid, an increased risk of death was revealed prior to the release of the drug. At the same time, it doesn’t slow down the progression of Parkinson’s. In some cases, it may even add to Parkinson’s related psychosis.
These are all items to take into consideration prior to choosing a pharmaceutical drug like Nuplaza, or any other form of medication. The more knowledge you have beforehand, the more equipped you will be to make an informed decision.
Cummings J, et al. Pimavanserin for patients with Parkinson’s disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014 Feb 8;383(9916):533-40.
Safety Signals for Two Novel Drugs. The Institute for Safe Medication Practices (ISMP) QuarterWatch. Nov 2017
Dana Nicholas is a freelance writer and researcher in the field of natural and alternative healing. She has over 20 years of experience working with many noted health authors and anti-aging professionals, including James Balch, M.D., Dr. Linda Page, “Amazon” John Easterling and Al Sears M.D. Dana’s goal is to keep you up-to-date on information, news and breakthroughs that can have a direct impact on your health, your quality of life… and your lifespan. “I’m absolutely convinced that America’s misguided trust in mainstream medicine – including reliance on the government to regulate our food and medicine supply – is killing us, slowly but surely,” she cautions. “By sharing what I’ve learned throughout the years I hope I can empower others to take control over their own health.”