In 2016, a cadre of family members stood in front of the U.S. Food and Drug Administration to urge the agency to approve a new drug called Nuplazid that could help those suffering from psychosis associated with Parkinson’s disease.
Within two years of the FDA approving the drug for use in patients with Parkinson’s disease, Nuplazid was connected with more than 700 reports of deaths.
The antipsychotic drug was approved under the FDA’s Breakthrough Therapy designation, which allows a drug to be approved in expedited fashion if it shows substantial improvement over existing therapies.
However, the increasing number of deaths and weak evidence suggests that the benefits of Nuplazid do not outweigh the risks. Now, scientists are wondering whether Nuplazid should be taken at all while those whose family members died while taking the drug start exploring the possibility of lawsuits.