00:53 - Source: CNN
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A drug safety watchdog has renewed its criticism of the government’s approval of a Parkinson’s psychosis medication and is calling for stronger warnings on its label for patients and their families.

Deemed a “breakthrough” medication, Nuplazid received an expedited review and was approved by the Food and Drug Administration in 2016. The agency ruled that the potential benefits for a desperate patient population outweighed its risks, making it the only drug on the market approved to combat hallucinations and delusions in Parkinson’s patients.

In the wake of a high number of death reports submitted to the federal government about patients taking Nuplazid, the FDA conducted a safety evaluation last year. It announced in September that it had found no “new or unexpected” risks that weren’t already taken into account at the time of approval and deemed no further action was necessary.

But a report released Wednesday by a team of medical researchers, safety experts and doctors at the nonprofit Institute for Safe Medication Practices, or ISMP, says that the underlying documents from the FDA’s evaluation leave a number of questions about the drug’s safety and efficacy unanswered. As a result, the institute said it does not believe the “reassurance” from the FDA was warranted.

Both the FDA and drugmaker Acadia Pharmaceuticals – which is under investigation by the Department of Justice for its sales and marketing of Nuplazid – have stood by the drug. They have attributed the number of deaths to an already sick population and the company’s distribution system. Acadia distributes Nuplazid through a network of specialty pharmacies that has made it more likely the company would learn of deaths from both patients and caregivers, which it is required to pass along to the FDA. The majority of the death reports reviewed by the FDA were submitted to the agency by Acadia. “If the reporting rate from the specialty pharmacy channel were as low as it was from other channels, the overall mortality reporting rate would be 88% lower,” an FDA official wrote in documents from the agency’s safety evaluation of Nuplazid last year.

The FDA declined to comment on the ISMP report, saying “in general the FDA does not comment on individual studies or reports, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect the public health.”

Acadia disputed the findings of the ISMP report, calling them “severe mischaracterizations and conjecture about the safety and efficacy of NUPLAZID” and said the report did not provide a complete characterization of the “benefit/risk profile” of Nuplazid.

ISMP said it stood by its full report, saying it “is a scientific report that is based on published data, FDA documents, and experience of our expert project team. … The source documents and information we cite provide abundant support for our findings of fact and conclusions about drug risks and benefits.”

Before the FDA launched this most recent safety review, ISMP had issued a report in 2017 about the adverse events being reported to the FDA, noting that the agency’s medical reviewer had recommended against the drug’s approval in 2016.

Now, in the wake of the FDA’s September conclusion that no changes were needed and that Nuplazid’s current label adequately describes its risks, the group is again arguing that Nuplazid was approved by the federal government too quickly, without strong enough evidence that its benefits outweigh its risks.

“The FDA should re-evaluate whether this drug has benefits that outweigh its still poorly defined risks,” the report states. “We continue to agree with the original medical review of [Nuplazid] that recommended against approval.”

Related: New Parkinson’s psychosis drug target of DOJ investigation

In response to the ISMP report, Acadia cited the FDA’s conclusion, including how Nuplazid’s distribution system contributed to the high number of reports of death and other adverse events. The company told CNN it is committed to “rigorous and ongoing safety monitoring and reporting.”

Authors of the ISMP report noted that deaths of patients taking Nuplazid have continued to be reported to the FDA and urged the agency to modernize its reporting system so it is better able to identify whether deaths or adverse events are related to medications patients are taking. In the case of Nuplazid, ISMP said FDA safety reviewers had found that many of the death reports contained too little detail to determine whether Nuplazid had been a contributing factor – a problem ISMP said was not unique to Nuplazid.