Our Philadelphia Nuplazid drug injury lawyers are evaluating cases involving serious injury or death from use of the drug Nuplazid. Nuplazid is an atypical antipsychotic drug manufactured and marketed by Acadia Pharmaceuticals, Inc.
Nuplazid was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2016, to treat psychosis-related hallucinations and delusions in sufferers of Parkinson’s Disease (PD). As of April 9, 2018, Nuplazid may be linked to more than 700 deaths, according to adverse event reports received since its release in June 2016.
Nuplazid and Parkinson’s Disease
Parkinson’s is a neurological disorder that occurs when dopamine producing brain cells are damaged or die. Approximately 50 percent of Parkinson’s patients experience hallucinations and / or delusions known as Parkinson’s Disease Psychosis (PDP). A patient who is hallucinating will hear or see things that do not really exist, while a patient experiencing delusions will form false beliefs that are not based in reality.
As an antipsychotic, selective serotonin inverse agonist drug, Nuplazid works by blocking PD patients’ 5-HT2A serotonin receptors, which may contribute to PDP. Because Nuplazid was categorized as a “breakthrough therapy,” it was approved following an expedited process for its development and review.
Although approval under the expedited process still requires a showing that a drug’s benefits outweigh its risks, additional adverse event reports revealed that Nuplazid sometimes:
- failed to reduce PD psychosis, or
- caused a worsening of PD psychosis symptoms
Nuplazid’s expedited approval followed a single clinical trial that not only showed a small treatment effect, but also revealed a more than doubled risk of death and other serious adverse events.
According to the Institute for Safe Medicine Practices, 244 deaths were reported as adverse events following use of Nuplazid for the 12-month period ending in March 2017. As of December 31, 2017, the FDA had received 712 death reports associated with Nuplazid.
Although Nuplazid contains an FDA black box warning advising of the increased risk of death in patients with dementia-related psychosis unrelated to Parkinson’s, it does not warn of the increased risk of death in Parkinson’s patients.
Lawsuits filed by Philadelphia Nuplazid drug injury lawyers may allege that Nuplazid manufacturer Acadia Pharmaceuticals, Inc.:
- manufactured and marketed an unreasonably dangerous drug
- released Nuplazid to the marketplace with knowledge of serious Nuplazid side effects, including an increased risk of death
- continued to produce and market Nuplazid after receiving adverse event reports of significant numbers of deaths following Nuplazid use
- failed to adequately warn physicians and the public about the serious risks associated with use of Nuplazid
Contact our Philadelphia Nuplazid Drug Injury Lawyers
If you have been seriously injured or a loved one has died following use of the Parkinson’s Disease drug Nuplazid, you may be entitled to compensation from the manufacturer. Contact our Philadelphia Nuplazid drug injury lawyers, today, for a cost-free evaluation of your case.