Amidst reports of safety concerns involving pimavanserin, a drug approved to treat psychosis symptoms among patients with Parkinson’s disease, the Food and Drug Administration stated it has begun reassessing the safety of the drug. The agency granted pimavanserin (Nuplazid, Acadia Pharmaceuticals) breakthrough therapy designation for the treatment of hallucinations and delusions associated with psychosis in patients with Parkinson’s disease, as well as priority review status. These designations help to expedite the development and review of drugs where preliminary clinical evidence indicates the drug may demonstrate substantial improvement compared with available therapy on a clinically significant endpoint. As previously reported in Caring (FDA approves first drug to treat Parkinson’s psychosis. 2016;17:6 or https://doi.org/10.1016/j.carage.2016.05.010), the FDA’s Psychopharmacologic Drugs Advisory Committee voted 12-2 that the benefits of pimavanserin outweighed the risks, based on the positive results of a single phase 3 study of 199 patients with Parkinson’s disease psychosis. Pimavanserin went on to receive FDA approval in April 2016, making it the first drug available for the treatment of hallucinations and delusions in this patient population. The present safety concerns were brought to light in a CNN report published on April 9, 2018, indicating that between the drug’s launch in June 2016 and March 2017, the FDA received 244 reports of death. The data were culled from an Institute for Safe Medication Practices analysis, which also found 487 reports of hallucinations, 333 reports of ineffectiveness, and 258 reports of a confusional state with the drug. In more recent data, the FDA Adverse Events Reporting System (FAERS) currently has the number of reported death cases with pimavanserin at more than 700. The FDA has … not identified a specific safety issue that is not already adequately described in the product labeling. During a budget hearing in April, FDA Commissioner Scott Gottlieb faced questioning about pimavanserin, with Rosa DeLauro (D-CT) wanting to know why the drug was still on the market after the reports of death associated with the drug surfaced. Mr. Gottlieb responded that he would “take another look” at pimavanserin, according to a CNN report published on April 25, 2018. The FDA commented in the report that it had been conducting an evaluation on pimavanserin for “several weeks,” suggesting its review predated the publishing of the first CNN article. In a statement to the San Diego Union-Tribune, the FDA added that based on FAERS data, “The FDA has, at this time, not identified a specific safety issue that is not already adequately described in the product labeling. … The FDA will continue to monitor adverse events reported with Nuplazid and will update the public as new information becomes available.” Responding in the initial CNN article, Acadia Pharmaceuticals said after analyzing reports, there “is nothing to suggest a causal relationship” with pimavanserin, and that Acadia’s calculated mortality rate for the drug is lower than the rate for the general population of Parkinson’s disease psychosis patients covered by Medicare. The manufacturer is now evaluating the safety and efficacy of pimavanserin in patients with Alzheimer’s disease psychosis. Brian Ellis is a freelance writer and editor based in NJ.