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Safety Watchdog questions the approval of Parkinson's disease by the FDA



Nuplazide was called a "breakthrough" and received an accelerated review approved by the Food and Drug Administration in 2016. The agency ruled that the potential benefit to a desperate patient population outweighed their risks and thus the market's only drug market was approved to combat hallucinations and delusions in Parkinson's patients.

However, a report released Wednesday by a team of medical researchers, security experts and physicians from the Non-Profit Institute for Safe Treatment Methods (ISMP) said the FDA's underlying documents raised a number of questions about drug safety and safety on the effects of the drug raise effectiveness unanswered. Therefore, the institute said it does not believe the FDA's "reinsurance" is warranted.
Both the FDA and drug maker Acadia Pharmaceuticals ̵
1; currently under investigation by the Department of Justice for its distribution and commercialization of nuplazide – have joined the drug. They attributed the number of deaths to an already ill population and the company's distribution system. Acadia sells Nuplazid through a network of specialty pharmacies, which makes it more likely that the company will suffer deaths from both patients and caregivers, which must be passed on to the FDA. The majority of FDA-approved death reports were submitted to the Acadia Agency. "If the reporting rate from the specialty pharmacy channel was as low as it was from other channels, the mortality rate would be 88% lower overall," an FDA official wrote in Nuplazid Agency's safety assessment documents last year.
 The FDA-feared drug was risky; reports of deaths now trigger concern

The FDA declined to comment on the ISMP report, saying: "In general, the FDA does not comment on individual studies or reports, but rather evaluates them as part of the evidence to find a better one Understanding of a particular problem and support in our mission to protect public health. "

Acadia denied the findings of the ISMP report and called them" serious misstatements and guesses about the safety and efficacy of NUPLAZID. " The report did not allow a complete characterization of Nuplazid's benefit-risk profile.

ISMP said it stood by its full report and said it was "a scientific report based on published data, FDA documents and the experience of our team of experts … The source documents and information we provide provide ample support for our findings of fact and conclusions about the risks and benefits of drugs. "

Prior to the FDA launching this most recent security review, ISMP published a report on the FDA-related adverse events in 2017, stating that the agency's medical examiner was banned from doing so Year 2016 against the approval of the drug had recommended.

Following the September FDA's conclusion that no changes were needed and that Nuplazid's current label adequately describes the risks, the group reiterates that Nuplazid was over-approved by the federal government without sufficient evidence that its benefits outweigh the risks.

"The FDA should reassess whether this drug has benefits that outweigh its still poorly defined risks," the report said. "We continue to agree with the original medical review of [Nuplazid] recommended against approval."

Related: New Parkinson's Psychotherapy Approved for DOJ Examinations

In response to the ISMP report, Acadia cited the FDA's conclusion, including how the Nuplazid distribution system contributes to the high number of reports of death and others contributed to adverse events. The company told CNN that it should commit to "strict and continuous monitoring and reporting of safety".

Authors of the ISMP report found that deaths from non-nasal acid patients continued to be reported to the FDA and urged the agency to modernize its reporting system to better identify if deaths or adverse events are related to medications In the case of Nuplazid, ISMP said that the FDA security reviewers found that many of the death reports contained too little detail to determine if nubercidol was a factor – a problem that, according to the ISMP, is not just for nuplazide.

The FDA noted that the risks of nuplazide are already covered by the label of the drug, which contains a black box warning. However, the ISMP said it was concerned that this warning – which indicates "increased mortality in elderly patients with dementia-related psychosis" – is not clear.

Nuplazide is approved for the treatment of Parkinson's disease (PDP) only and is not approved for the treatment of dementia. However, the FDA has confirmed to CNN that this black box warning also applies to PDP patients, which means that they also have an increased risk of death.

"The FDA should revise the current – and misunderstood – Boxed Warning to clarify what it means: Treatment with [Nuplazid] could lead to a significantly increased risk of death – similar to other antipsychotic drugs in elderly patient populations used with psychosis, "says the ISMP report.

It was also recommended to go ahead with the label to specifically warn doctors not to prescribe the drug in combination with other antipsychotics that have been shown to double the risk of death in Parkinson's patients.

Acadia referred to an FDA statement in which the agency reminded physicians to be aware of the risks of using Nuplazide with other antipsychotics, and said in the same statement that they had "potentially prescribing patterns." , The company previously told CNN that patients, caregivers and prescribers must consider the label and black box warning of nuplazide in the context of each patient's "assessed benefit / risk and other factors" – including their age and severity ,

In addition to the guard dog's safety concerns, ISMP said it was not convinced that Nuplazid helped patients. It said the agency may have made a mistake by allowing Nuplazide because of the efficacy found in a clinical trial – although no "statistically significant benefit" had been shown in three previous studies, as the FDA has stated in public documents. Acadia continues to promote the efficacy of the drug, pointing out that the successful six-week study of approximately 200 patients was "clinically robust and statistically significant in efficacy" and that it was based on its approval and on other supporting studies. 19659021] Dr. med. Daniel Weintraub, an Acadia consultant and Parkinson's expert, was not as concerned about Nuplazid as the authors of the ISMP report, but suggested that further clinical trials and other investigations be carried out as "there is currently insufficient data available …" that nubercid is or is not associated with an increased mortality or morbidity risk in patients with Parkinson's disease psychosis. "Weintraub, who was asked by CNN to review the ISMP report, also said that in its interpretation, the label states that the black box warning only applies to people with dementia, so a prescribing doctor would use the label he reads, probably believing that he only applies to those PDP patients who also suffer from dementia, he said.

CNN has been heard by several family members who said the drug helped ease their relatives' hallucinations To curb obvious side effects, and several prescribers said they had no concerns about the drug and welcomed FDA-approved treatment option for such a difficult condition, others wondered if Nuplazid contributed to the demise or death of their family member or said the drug did not work.

The company cited in the FDA study Data showed that nearly half of the patients taking the drug since it was on the market had died or had discontinued Nuplazid, whether due to cost, efficacy, side effects, or other reasons within the first two months after taking it Medicines Acadia said that there are a variety of reasons why people sell a drug, including "those who are often unrelated to the drug."

The company noted that it is reviewing documents from the FDA's Department of Psychiatry Products, which states that "the death reporting rate relative to the total number of patients taking [Nuplazid] changes little with exposure time If [Nuplazid] a significant number of deaths, these deaths are more likely to occur and reported within the first weeks or months of use. "

The ISMP report said that its concerns over the effectiveness of the drug by this company data" strengthened "were. This indicates that the high dropout rate is due to patients who have left the drug because it did not work, not necessarily due to death. And the FDA previously told CNN that "the most likely reason for stopping was that they did not find it helpful."

Do you have information about Nuplazid or other drugs? Send us an email to watchdog@cnn.com.


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