The safety guard asks for FDA's permission for drugs psychosis Parkinson


Considered as a "advanced" treatment, Nuplazid was reviewed quickly and approved by the Food and Drug Administration in 2016. The management of the campaign meant that the potential benefits could be t emergency patients have been increasing the take-up of intelligence and disorders events in Parkinson's.

But a report released by a team of medical researchers, safety experts and doctors at the Non-profit Institute of Safety Safety Practices, or ISMP, says that the core documents from the FDA assessment leave a number of questions about safety and effectiveness. unwanted drugs. As a result, the institution said it did not think the FDA had a qualification.

The FDA and drugmaker Acadia Pharmaceuticals – which is overseen by the Justice Department for sale and marketing of Nuplazid – have stood with the drug. They have delivered the number of deaths to the already ill population and the company's distribution system. Acadia distributes Nuplazid through a network of special treatments which makes it more likely that the company will learn deaths from all patients and carers, and must be handed over to the FDA. Most of the fatal reports made by the FDA were reviewed by Acadia. "Had the level of reporting by the specialist pharmacy channel been as low as it was from other channels, the overall level of fatality would be 88% lower," FDA officer wrote in documents from the organisation's safety assessment Nuplazid last year.
A dangerous FDA drug was dangerous; now reports of deaths have been causing concern

The FDA declined to comment on the ISMP report, saying "generally FDA does not refer to individual investigations or reports, but assessing them as part of evidence evidence to our understanding." to take forward a specific issue and to assist with our public health protection mission. ” t

Academia discussed the findings of the ISMP report, saying it was a "bad and perceptual mistake of the safety and effectiveness of NUPLAZID" and said the report did not contain a full "benefit / risk" report of Nuplazid. .

The ISMP said that the report is full, saying “a scientific report is based on published data, FDA documents, and knowledge of our famous project team. Our findings are well supported by the source documents and the information we provide. Truth and decisions about the risks and benefits of drugs. "

Before launching this latest safety audit by FDA, ISMP had issued a report in 2017 on the serious incidents being reported to the FDA, saying the organisation's medical reviewer had recommended a recommendation. drugs were licensed in 2016.

Now, after the FDA's decision in September that changes were not necessary, and the Nuplazid presence defines their hazards clearly, the group are relying on Nuplazid's allows the federal government prematurely, without strong evidence to suggest that the benefits far outweigh its benefits. dangers.

“The FDA should reconsider the existence of this drug which is a bigger risk than those which are still clearly explained,” the report states. “We agree with the first t medical examination [Nuplazid] recommended against an agreement. "

Related: Sweet target Psychosis new Parkinson's for DOJ examination

In response to the ISMP report, Acadia nominated the FDA's decision, including how the Nuplazid transmission system contributed to the increased number of deaths and other adverse incidents. The company told CNN that it promises to "report and report tight and safe to safety".

The authors of the ISMP report identified that the death of patients taking Nuplazid has continued to report to the FDA and urged the group to update their reporting system to make it more efficient. finding bad deaths or bad incidents. On Nuplazid, ISMP said that the FDA safety inspectors had found that in many of the death statements there was too little information to find out if Nuplazid had been influential – no problem Specific ISMP for Nuplazid.

The FDA concluded that the Nuplazid risks are already captured by the drug slab, which includes a black box warning. But ISMP said it is worrying that this warning – which is warning that there is “greater mortality in elderly patients with dementia-related illnesses” – is clear.

Nuplazid is only allowed to treat Psychosis of Parkinson's, or PDP, and being treated with dementia is not allowed. However, the FDA confirmed to CNN that this black box warning should also apply to PDP patients – meaning they are also at an increased risk of death.

“The FDA should review the current situation – and which is easy to understand – so that it can clearly define what it means: medicine with [Nuplazid] "This may lead to an increased risk of death – similar to what was seen when using other antipsychotics in the population of elderly people with psychosis," said the ISMP report.

He also recommended that the bed go further to warn doctors of the drug not being given in conjunction with other antipsychotics, which had been shown to double the risk of death in Parkinson's patients.

Acadia drew attention to the FDA recital which the group reminded doctors that they knew about the dangers of using Nuplazid with other anti-antiotics, saying in the same statement that he was aware of the dangers of using Nuplazid. that it could be patterned. ' The previous company told CNN that patients, carers and prescribers need to consider a Nuplazid leaflet and a black box warning in the context of "all benefits / assessed risks and other issues" of all patients – including: t their age and condition.

In addition to the safety guarder's concerns, ISMP said it is not clear that Nuplazid is helping patients. She said the group was "lost" when she agreed Nuplazid which was based on the effectiveness of one clinical trial – although there was no "statistical standardized benefit" in the t shown in three previous studies, how the FDA has recognized in public documents. Acadia continues to deliver drug efficiency, saying that the successful six-week survey of around 200 patients "in terms of clinical and statistically significant difficulties", indicated that the drug's license was based on this and " t other supporting surveys. "

Dr Daniel Weintraub, an Acadian consultant and Parkinson's disease specialist, did not share the same concerns about Nuplazid as authors of the ISMP report, but suggested more clinical trials and other research could be carried out because "data to At present, Nuplazid is associated with mortality greater than the risk of death in patients with Parkinson's disease. "Weintraub, who asked CNN to review the ISMP report, said:" In addition, in its interpretation, the bed says that the black box warning only covers people with dementia linked to dementia. So it seems that an orderer would read the leaflet affecting those PDP patients who are also suffering from dementia, he said.

CNN has heard from several members of the family that the drug has helped people who could be surrounded by very little impact, and a number of appointed doctors said they don't care about the drug and t welcomes any option agreed with FDA for such a difficult scenario. Others have questioned Nuplazid to reduce or death the family member or say the drug was not working.

Company data cited in the FDA review revealed that almost half of all patients who took drugs had stopped the market, or stopped Nuplazid, at least through cost, efficiency. , undercurrent or other purposes, within the first two months of the acquisition of the substance. Acadia has said that there is a wide range of reasons why people stop taking medicines, including “those that aren't often associated with the drug.”

The company said it was reviewing documents from the FDA's Department of Shopping Studies, which said "there is a mortality rate compared to the total number of patients who are receiving [Nuplazid] it does not change much with the exposure. If so [Nuplazid] leading to several deaths, these deaths were more likely to occur and were reported within a few weeks or months of use. "

The ISMP report stated that their concerns about the effectiveness of the drug "have been ratified" by this company data – suggesting the high completion rate was due to patients recovering from the drug as it did not work, like about death. And the FDA previously told CNN that “the most likely reason to stop them is that they didn't find it's useful. "

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