Following the hundreds of death reports in which Nuplazid (pimavanserin) was cited as a so-called “suspect” medication, the U.S. Food and Drug Administration (FDA) has announced that it is conducting a new evaluation of the drug’s safety, CNN disclosed.
Manufactured by Acadia Pharmaceuticals, Nuplazid was approved in 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis and is the only medication on the market to address this class of patients.
The FDA approved Nuplazid as a “breakthrough therapy,” a designation that indicates a drug has demonstrated “substantial improvement” in patients with serious or life-threatening diseases compared to treatments already on the market. This designation is meant to expedite the approval of drugs intended for serious conditions and which have been green-lighted by a preliminary clinical trial.
However, despite past criticisms of the FDA’s slow drug approval process, there have been concerns regarding Nuplazid’s safety. These concerns state that, in this particular case, the agency may have been too quick to approve a medication for which the risks had not been thoroughly assessed.
According to CNN, an evaluation of Acadia’s drug has been underway for several weeks. Yet the announcement of the FDA re-examination regarding the Parkinson’s psychosis medication was only made last week, during a congressional hearing.
When questioned about the agency’s response to the safety concerns surrounding Nuplazid, FDA Commissioner Scott Gottlieb revealed that he would “take another look” at the risks associated with Acadia’s drug.
— Dr. Liz Samander (@DrLizSamander) April 25, 2018
“How many more adverse events do we have to have reported? How many people, quite frankly, have to die? Why does the industry always take precedence over public health and safety?” U.S. Rep. Rosa DeLauro asked at the hearing.
DeLauro, who is a member and former chair of the congressional subcommittee responsible for funding and overseeing the FDA, said that the “staggering” and “unprecedented” number of reports in which Nuplazid was cited as a suspect medication should be enough to take the drug off the market.
“I don’t know why it should stay on the market, especially when the FDA has not determined it to be safe and while the number of adverse events continues to soar,” DeLauro told Gottlieb.
The U.S. rep. also voiced her concern that Acadia may be trying to get Nuplazid approved for the treatment of dementia-related psychosis, in which case it would be prescribed to a larger population.
To clarify, the adverse event reports citing Nuplazid as a suspect medication do not mean that the drug has been officially established to be the cause of harm. These reports don’t usually stem from official investigations but are in fact voluntarily filed by caregivers, doctors, and other medical professionals. However, the FDA does take them into account when monitoring the potential issues of medications and updates the drugs’ labels or restricts their use if necessary.
The agency stated that, although Nuplazid was continuously monitored since its approval, it had “not identified a specific safety issue” that wasn’t already reflected on the drug’s label.
The initial medical review of Nuplazid already stated that patients taking pimavanserin during the drug trial had a double rate of serious outcomes, including death, compared with those taking the placebo, CNN notes.
In 2016, an FDA advisory committee concluded that Nuplazid’s potential benefits outweighed the risks, pointing out the drug doesn’t have any other safe alternatives.