This Relatively New Parkinson’s Disease Drug Already Been Implicated In Hundreds Of Death Cases, While Only Being On Market Since 2016

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Two years ago the FDA approved Nuplazid (pimaveanserin) as a new kind of antipsychotic drug which is intended to treat hallucinations, delusions, and other symptoms of psychosis among patients with Parkinson’s disease. Reportedly, for this particular medical condition there is a patient population numbering in the hundreds of thousands with a typical onset around age 65.

A report about Nuplazid published in the November 1, 2017 edition of the Institute for Safe Medication Practices (ISMP) QuarterWatch, however, has raised some serious concerns about the safety of this still relatively new Parkinson’s disease drug.

Building upon that 2017 ISMP QuarterWatch report, more recently CNN covered this emerging drug safety issue in this April 2018 news story, “FDA worried drug was risky; now reports of deaths spark concern“.

An FDA Advisory Committee considered whether to recommend approval of Nuplazid in March 2016. In more detail, according to the April 2018 CNN Investigates story:

The committee voted 12-2 and recommended that the FDA approve Nuplazid for the treatment of Parkinson’s disease psychosis based on a six-week study of about 200 patients. Three previous studies of the drug did not show that it was effective, [the physician who led the FDA’s medical review, Dr. Paul Andreason] said in his medical review, though they showed similar risk.

Even some committee members who voted in favor of the drug expressed reservations, according to the hearing transcript. “I guess I’m hoping that the risks are going to be small, and I think the benefits for some of these people who are very sick and whose families are affected by this, I think they’re probably willing to take that risk,” one physician stated. Another committee member said she wouldn’t have voted for the drug’s approval if there had been a safe and effective alternative on the market. A third made a “plea” to the FDA to “consider a large observational study so we can ensure that, once it goes into real-world use, that the benefits will outweigh the risks.”

Nuplazid was thereafter approved by the FDA in April 2016, and became available to US patients in June 2016.

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Returning to the April 2018 CNN news story about Nuplazid:

Shortly after the drug’s release, patients’ family members, doctors and other health care professionals started reporting “adverse events” possibly linked to the medication — including deaths, life-threatening incidents, falls, insomnia, nausea and fatigue. In more than 1,000 reports, patients continued to experience hallucinations while on Nuplazid.

In November, an analysis released by a nonprofit health care organization, the Institute for Safe Medication Practices, warned that 244 deaths had been reported to the FDA between the drug’s launch and March 2017. The organization also noted that hundreds of reports suggested the drug was “not providing the expected benefit” or potentially worsening the condition….

Since the institute released its analysis, FDA data shows that the number of reported deaths has risen to more than 700. As of last June, Nuplazid was the only medication listed as “suspect” in at least 500 of the death reports.

We point out the current Prescribing Information for Nuplazid (accessed 4/9/18) does have a so-called “black-box warning” which relates to death, as follows:

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WARNING:  INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
• NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis [see Warnings and Precautions 5.1)].

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Nonetheless, Nuplazid is drawing increased scrutiny, as demonstrated by these two excerpts from the April 2018 CNN news story which focuses on patient deaths:

1. “This is almost unheard of, to have this many deaths reported,” said Diana Zuckerman, founder and president of the nonprofit thinktank the National Center for Health Research, adding that because reports are voluntary, potential problems may be underreported. “You just don’t see this with most new drugs — you don’t see all these reports — so you have to take it seriously.”
2. Geriatric psychiatrist and former FDA medical officer Susan Molchan said that the number of deaths is alarming and questioned whether patients and their families are aware of the risks associated with the drug.

We will continue to watch developments concerning the safety profile of Nuplazid, including possible regulatory action by the FDA.

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