A recent CNN report has highlighted concerning information about Nuplazid (pimavanserin), including that studies regarding Nuplazid Parkinson’s medication suggest a shocking increase in the risk of adverse events.
Patients who were desperate for a treatment for Parkinson’s-related hallucinations, delusions, and other psychosis symptoms turned to Nuplazid after it was approved, but experts say there’s little evidence the drug actually has any benefits.
Attorneys at Cutter Law are investigating claims against the Nuplazid drug on behalf of patients who were harmed by the medication.
Our attorneys are highly experienced at handling complex pharmaceutical litigation and have successfully handled cases against Boston Scientific, Guidant, and Medtronic, among other medical device manufacturers.
Nuplazid Parkinson’s Treatment
In June 2016, Nuplazid was released on the market as a treatment for hallucinations, delusions, and other psychosis symptoms linked to Parkinson’s disease, symptoms that can be devastating for patients.
According to the CNN report, however, the U.S. Food and Drug Administration (FDA) approved the Nuplazid drug despite the lead reviewer recommending against its approval.
The agency also reportedly approved the drug based on only one scientific study, even though three prior studies found no Nuplazid benefits.
Nuplazid Approval
The reason Nuplazid was approved so quickly was that it is considered a breakthrough therapy in that it showed a substantial improvement in patients who have a serious disease when compared with already available treatments.
Dr. Paul Andreason was the lead reviewer for Nuplazid, which is known generically as pimavanserin. He cautioned against approving the drug, noting that clinical trials showed patients taking the drug suffered serious outcomes more than twice as often as patients taking a placebo.
Furthermore, he argued, three other studies did not show any significant benefit to the drug. The FDA dismissed the concerns and voted 12-2 to approve Nuplazid for Parkinson’s hallucinations and other side effects.
Patients, however, are reportedly suffering severe Nuplazid side effects.
Nuplazid Medication Side Effects
In its November 2017 report on Nuplazid, the Institute for Safe Medicine Practices (ISMP) found an astonishing number of reports of adverse events linked to the Nuplazid drug. According to its quarterly report, from the time Nuplazid was approved in June 2016 to March 2017, there were 2,236 reports of adverse events related to Nuplazid. The four most common reports were for:
Hallucinations (487 reports)
Ineffective drug (333 reports)
Confusional state (258 reports)
Death (244 reports)
The ISMP noted that the adverse Nuplazid reports support the clinical trial reports that found hallucinations and confusional states occurred more frequently in patients treated with Nuplazid medication than those given a placebo.
“The overall message in these adverse event reports is that hundreds of health professionals are trying this new drug with their patients and reporting that either it is not providing the expected benefit or making some psychosis worse,” the ISMP wrote. “The large number of deaths also remains a concern in a setting where increased mortality was at least suspected if not proven in the clinical trials.
The FDA and manufacturer should consider additional warnings and other measures to deal with inappropriate combination therapy with antipsychotic drugs.”
Nuplazid Lawsuit
Attorneys at Cutter Law are investigating Nuplazid lawsuits on behalf of patients who were treated with the Parkinson’s medication and suffered serious side effects, or their surviving family members.
Those affected by the medication’s adverse events may be entitled to compensation for medical bills, wrongful death, and pain and suffering.
If you or someone you love was affected by Nuplazid Parkinson’s treatment, contact a Nuplazid attorney at Cutter Law. Our attorneys are available to discuss your circumstances and explain your legal options.