Tennessee Nuplazid Lawyer
Approximately 1 million people in the United States suffer from Parkinson’s Disease, a complex neurodegenerative disorder that has no known cure. Although Parkinson’s itself is not fatal, its complications are. And in recent years, a number of pharmaceutical companies have offered treatments designed to alleviate some of the more serious symptoms of Parkinson’s Disease.
One such treatment is pimavanserin, a drug marketed by Acadia Pharmaceuticals under the name Nuplazid. Specifically, Nuplazid is intended to work as an anti-psychotic medication. Many Parkinson’s victims suffer from psychosis–that is to say, they frequently experience delusions and hallucinations. Acadia claims Nuplazid can help in balancing abnormal chemical levels in the brain, thereby reducing the frequency of psychotic episodes.
But there are serious questions about the safety and effectiveness of Nuplazid. The FDA has received a significant number of “adverse event reports” related to Nuplazid, which suggests the drug may cause serious side effects including death. If you have a family member taking Nuplazid and have concerns the drug may be doing more harm than good, you should speak with the Tennessee Nuplazid lawyers at Fox & Farley today.
FDA Fast Tracked Nuplazid Approval Despite Warning Signs
Nuplazid was fast-tracked through the FDA approval process. In 2012, Congress authorized the so-called “breakthrough therapy” designation. This allows drugs to obtain faster approval, provided an FDA advisory committee determines there is sufficient evidence that a proposed drug’s benefits outweigh the potential risks.
Nuplazid received the breakthrough therapy designation following intense pressure from families of Parkinson’s patients, who were desperate for some relief from their relative’s psychotic episodes. Given the lack of alternative treatments, many FDA officials decided Nuplazid was worth the risk. Only 2 members of the 14-person advisory committee voted against Nuplazid’s early approval.
Yet according to an April 2018 CNN report, even some of the committee members who voted in favor of the breakthrough therapy designation “expressed reservations” about the risks. Indeed, during the limited clinical trials of Nuplazid, FDA officials acknowledged that “experienced serious outcomes, including death, at more than double the rate of those taking [a] placebo.” Nevertheless, Acadia quickly sold hundreds of millions of dollars in Nuplazid prescriptions to families willing to try anything.
The result, according to a November 2017 report by the Institute for Safe Medication Practices, were “numerous reports that the drug was ineffective” in controlling hallucinations and the death of 244 patients as of March 2017. And that proved to be the tip of the proverbial iceberg: As of April 2018, the FDA’s own adverse events reporting system says there are more than 700 fatalities connected to Nuplazid.
Standing Up for Parkinson’s Patients
Acadia continues to defend the safety and effectiveness of Nuplazid. This should come as a surprise to nobody. Few drug manufacturers are willing to give up a lucrative new product, even one that has not been subject to the normal rigors of FDA clinical testing. This is why it is critical for the families of Parkinson’s patients to take action. If your loved one has died or suffered serious complications from using this drug, contact the experienced Tennessee Nuplazid lawyers at Fox & Farley today to schedule a free consultation.