Nuplazid Patient Deaths - Consumer Justice Foundation

Nuplazid Patient Deaths

Written by Faith Anderson on April 14, 2018

Reports of Deaths Linked to Parkinson’s Disease Psychosis Drug Spark Safety Concerns

Hundreds of patients have died while taking Nuplazid, a drug manufactured by San Diego-based Acadia Pharmaceuticals to control psychosis related to Parkinson’s disease, a debilitating movement disorder that affects hundreds of thousands of individuals and has a typical onset around age 65. If a family member of yours suffering from Parkinson’s disease took Nuplazid to control the hallucinations and delusions that sometimes accompany the disease, and that family member has since died or experienced devastating side effects, contact our consumer advocates at the Consumer Justice Foundation today. We can help put you in touch with a product liability lawyer who has experience representing individuals harmed by defective pharmaceutical drugs.

What is Nuplazid?

Nuplazid (pimavanserin) belongs to the antipsychotic family of medications used to treat mental health issues like bipolar disorder and schizophrenia. The drug works by blocking normal signaling with the serotonin receptors that mediate memory, leaning, cognition and other body functions. Nuplazid doesn’t slow the progression of Parkinson’s itself, but it has been shown to temporarily reduce mental disturbances associated with the disease. Nuplazid’s approval in April 2016 was expedited because the drug had been labeled a “breakthrough therapy,” a designation created by Congress in 2012 to fast-track medications that demonstrate a “substantial improvement” in patients with serious or life-threatening diseases that don’t have adequate existing treatments. Considered an experimental drug at the time it was approved, Nuplazid was the first treatment for Parkinson’s-related psychosis, a complication that causes hallucinations and delusions and occurs in approximately 40% of patients with the disease.

Reports of Patient Deaths from Nuplazid

In November 2017, the Institute for Safe Medication Practices (ISMP) reported in its QuarterWatch publication that Nuplazid’s FDA approval was based on limited scientific evidence that the benefits of the medication outweighed its risks. So limited in fact, that it was just one six-week study of about 200 patients showing a minimal treatment effect that resulted in Nuplazid’s approval, even though that trial followed three previous trials that failed to demonstrate any treatment benefit at all. The physician who led the FDA’s medical review of Nuplazid, Dr. Paul Andreason, advised against approving the Parkinson’s psychosis drug, but the committee ultimately voted 12-2 in favor of its approval. According to Andreason, patients taking Nuplazid during clinical trials experienced devastating side effects, including death, at more than double the rate of those taking the placebo.

Even some FDA committee members who voted in favor of approving the medication expressed concerns about the effects of the treatment in real-world situations. According to the hearing transcript, one physician said she wouldn’t have voted for Nuplazid if there was a safe and effective alternative treatment on the market. Another 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.” Still another said, “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.”

In the short time it has been on the market, Nuplazid has not only not provided the expected benefit for patients experiencing psychosis associated with Parkinson’s disease, it has worsened the condition in some. According to the 2017 QuarterWatch report, further analysis of the effects of Nuplazid on Parkinson’s disease patients experiencing hallucinations suggested that the drug was likely making the hallucinations worse, not better, or in other cases, was not providing the expected benefit. When confronted with preliminary results indicating a lack of benefit in regard to Nuplazid treatment, Acadia Pharmaceuticals claimed that the large amount of adverse event reports associated with the medication was likely due to its extensive contact with patients and healthcare providers through a specialty pharmacy network that distributed the drug. The company also said the reports of hallucinations in patients taking Nuplazid may have occurred before the drug became fully effective.

FDA Fails to Issue Updated Nuplazid Warning

Despite these new concerns about Nuplazid treatment risks, the FDA has not issued an updated safety communication warning the public about the potential for Nuplazid to cause serious or life-threatening side effects. Even after the shocking report linking Nuplazid to hundreds of patient deaths, the FDA indicated that it has received no new information about the potential risk of Nuplazid side effects that merits changing the existing drug warnings. The report in question, published by CNN, quoted medical experts and observers who indicated that the drug has been approved without an adequate regard for the risk it may pose for patients. In response to the report, federal regulators said in a statement issued on April 10, “Based on these data, the FDA has, at this time, not identified a specific safety issue that is not already adequately described in the product labeling.”

Contact a Nuplazid Injury Lawyer Today for Help

Since the ISMP issued its report in November 2017, FDA data shows that the number of deaths among patients taking Nuplazid has risen to 700, while other patients have suffered other adverse events possibly linked to the drug, including falls, life-threatening incidents, insomnia, fatigue and nausea. In more than 1,000 incident reports, patients taking Nuplazid continued to experienced hallucinations. But caregivers and family members of those with Parkinson’s may be desperate enough, as the FDA medical reviewer suggested, to look past the risks, in hopes that the drug brings their loved ones some semblance of peace. If you or your loved one has suffered serious side effects you believe to be related to the psychosis drug Nuplazid, contact a knowledgeable drug injury lawyer as soon as possible to discuss your legal options.

Posted Under: Dangerous Drugs, FDA - Food and Drug Administration, News, Nuplazid
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