When the FDA approved Nuplazid in April 2016, it included a boxed warning on the drug’s label stating that it may increase chances of death in elderly patients with dementia-related psychosis. Concerns have been raised that any potential benefits of the drug do not appear to outweigh the risks.
Motley Rice medical attorneys are reviewing these concerns and claims of harm suffered by Parkinson’s patients due to Nuplazid.
Contact a Nuplazid attorney
If you suffered a heart attack or a loved one tragically died after taking Nuplazid to treat Parkinson’s-related symptoms, contact medical attorney Carmen Scott by email or call1.800.768.4026 for more information or to discuss your potential claim.
If you believe that you may have a claim, consider contacting an attorney as soon as possible. A statute of limitations (SOL) may limit the time you have to file a claim. If you do not file your claim within the SOL, you may lose it forever.
Nuplazid (pimavanserin) Background
Roughly one million people suffer from Parkinson’s disease in the U.S., half of whom may experience hallucinations or delusions over the course of their illness, according to the FDA. Prior to Nuplazid’s approval in 2016, no remedy was available for patients in the U.S. who suffered from these advanced stage symptoms.
Nuplazid, manufactured by Acadia Pharmaceuticals Inc., was approved under an FDA program designated “Breakthrough Therapy” designed to expedite the development and review of drugs that are found to offer a substantial improvement over available treatments for serious conditions.
The FDA approved Nuplazid largely based on the results of a six-week clinical trial that involved 199 participants and claimed a decrease in “frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease.”
According to the FDA, the most common side effects reported during the clinical trial were:
Swelling of the ankles, legs and feet
Abnormal or confused state of mind
A study by the Institute for Safe Medication Practices, however, questioned the safety and efficacy of Nuplazid, claiming the FDA approved the drug based on the results of a single clinical trial, despite three previous trials that failed to show a benefit of the drug.