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The security guard questions the FDA approval for the Parkinson's psychosis drug



It is considered a "breakthrough" medicine, Nuplazid received an accelerated review and was approved by the Food and Drug Administration in 2016. The Agency ruled that the potential benefits to the desperate patient population are greater than the risks, making it the only drug in a market approved for hallucinations and delusions in Parkinson's patients.

But a report published Wednesday by a team of medical researchers, safety experts and doctors from the non-governmental institute for safe treatment practices, or the ISMP, says the key FDA assessment papers leave a number of questions about drug safety and efficacy without answer. As a result, the institute said it did not believe the FDA's "confidence" was justified. Both the FDA and the drug manufacturer Acadia Pharmaceuticals ̵
1; which are being investigated by the Ministry of Justice for the sale and marketing of Nuplazid – have remained of the drug. They attribute the number of deaths to the already sick population and the distribution system of the company. Acadia distributes Nuplazid through a network of specialized pharmacies that has made the company more likely to learn about the deaths of both patients and caregivers that need to be handed over to the FDA. Most of the death reports reviewed by the FDA were handed over to the agency by Acadia. "If the reporting rate of the specialized pharmacy channel was as low as the other channels, the overall reporting rate for mortality will be 88% lower," an FDA official said in a Nuflazid safety assessment last year .
  It was dangerous to the FDA; now reports of death sparks concern

The FDA refused to comment on the ISMP report, saying: "Overall, the FDA does not comment on individual studies or reports, but evaluates them as part of the evidence for further understanding of a specific issue and to cooperate for our mission to protect public health. "

Acadia challenged the conclusions of the ISMP report, calling them" severe incorrect features and assumptions about the safety and efficacy of NUPLAZID, "and said the report does not provide a full characterization of" benefit / risk office "of Nuplazid.

The ISMP stated that it stood in its full report, saying it was a scientific report based on published data, FDA documents, and the experience of our project expert team. about our facts and conclusions about the risks and benefits of drugs. "

Before the FDA launched this latest safety review, the ISMP issued a report in 2017 on the adverse events reported to the FDA, noting that the agency's medical expert recommended the approval of the drug in 2016 [19659006] following the FDA's September conclusion that there is no need for changes and that the current label of Nuplazid adequately describes the risks, the group once again argues that Nuplazid was approved by the federal government too quickly without strong evidence that its benefits outweigh the risks "The FDA has to reassess whether this drug has benefits that outweigh the still poorly defined risks," the report said, "We continue to agree with the original medical review [Nuplazid] recommended against approval." [19659011] In response to the ISMP report, Acadia cites the FDA's conclusion, including how the distribution system of Nuplazid has contributed to the large number of reports of death and other adverse events. The company told CNN that it is committed to "rigorous and ongoing monitoring and safety reporting."

The authors of the ISMP report note that the deaths of patients taking Nuplazid continue to be reported to the FDA and called on the Agency to modernize its reporting system so that it is better to determine whether the deaths or adverse events are related to the medicines your patients are taking. In the case of Nuplazid, the ISMP has stated that FDA safety experts have found that many of the death reports contain too little detail to determine whether Nuplazid is a contributing factor – a problem that ISMP says is not unique to Nuplazid. The FDA decided that the risks of Nuplazid are already covered by the drug label, which includes a black box warning. But the ISMP said it was worried that this warning – which warns that there is "increased mortality in elderly patients with dementia-related psychosis" – is unclear. Nuplazid is only approved for the treatment of Parkinson's or PDP and is not approved for the treatment of dementia. However, the FDA has confirmed to CNN that this black box warning is intended to apply to patients on PDP, which means they are also at increased risk of death.

"The FDA should review the current – and easily misunderstood – Boxed Warning to make clear what it means: treatment with [Nuplazid] may lead to a significantly increased risk of death – similar to what was observed with other antipsychotics in elderly patients with psychosis, "says the ISMP report and also recommends that the label goes further to warn physicians not to prescribe the drug in combination with other antipsychotics that have been shown to double the risk of death in Parkinson's patients

Aka Diana pointed out a FDA statement in which the agency reminded physicians to be aware of the risks of using Nuplazid with other antipsychotics, saying in the same statement that it noticed "potentially prescriptive patterns." The company previously told CNN that patients , caregivers and doctors should consider the Nuplazid label and the Black Box warning in the context of the "assessed benefit / risk and other factors" of each patient – including the age and severity of their condition.

In addition to safety concerns, the ISMP has stated that it remains unconvinced that Nuplazid helps patients. According to him, the agency may have mistaken when approving Nuplazid on the basis of the efficacy found in a clinical trial – although three previous studies did not show a "statistically significant benefit" as the FDA noted in public papers. Acadia continues to promote the efficacy of the drug, noting that the successful six-week study of about 200 patients "showed clinically robust and highly statistically significant efficacy," and that drug approval is based on this as well as "other supportive research." 19659021] Dr. Daniel Weintraub, Acadia's consultant and Parkinson's disease expert, do not share the same level of concern about Nuplazid as the authors of the ISMP report but suggest that more clinical trials and other studies will be conducted as "there is currently insufficient data. .. to say that Nuplazid is or is not associated with increased mortality or risk of morbidity in patients with Parkinson's disease psychosis. Weintraub, whom CNN has asked to review the ISMP report, also said that in his interpretation, the label states that the black box warning refers only to those with dementia-related psychosis. Therefore, a prescribing drug that reads the label will probably think it is only applied to those PDP patients who also suffer from dementia, he said.

CNN has heard from several family members that the drug has helped hallucinations to their loved ones with several visible side effects and several doctors prescribing the drug have said they have no concerns about the drug and have accepted approved by the FDA. possibility of such a difficult condition. Other people have doubts about whether Nuplazid has contributed to the decline or death of their family member, or has said that the drug is not working.

The company data quoted in the FDA review showed that nearly half of the patients who took the drug after the drug had died or stopped using Nuplazid due to cost, efficacy, side effects or other causes, within the first two months of adoption. the medicine. Acadia said there is a wide variety of reasons why people stop taking medications, including "those that are often not drug-related."

The company pointed to a review of FDA psychiatric department records, which stated that "the rate of reporting deaths in the total number of patients taking [Nuplazid] slightly changed with the duration of exposure [Nuplazid]. these deaths are more likely to occur and reported during the first few weeks or months of use. "

The ISMP report states that its concerns about the efficacy of the drug are" reinforced "by the data of this company – which before olaga that the high rate of discontinuation of patients who have come out of the drug because it works, not necessarily because of death. A FDA previously told CNN that "the most likely reason for stopping is that they do not find it helpful." Do you have any information to share with Nuplazid or other medicines? Send us an email at watchdog@cnn.com.


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