The United States Food and Drug Administration (FDA) has decided to re-evaluate the safety of Acadia Pharmaceuticals’ Parkinson’s disease drug Nuplazid. The review of the drug comes amid reports linking it to hundreds of deaths among Parkinson’s patients who use the only medication approved for the treatment of psychiatric manifestations like hallucinations and delusions. 

CNN reported Wednesday that FDA Commissioner Scott Gottlieb revealed to Congress members last week that he would like to “take another look” at Acadia’s Nuplazid after it has been cited as the “suspect” of multiple deaths reported by caregivers, doctors and other medical professionals. The re-evaluation of the drug actually begun several weeks ago because of the growing concerns over its safety. 

“The FDA is conducting an evaluation of available information about Nuplazid,” and FDA spokesperson was quoted as saying by Business Insider. “The review has been going on for several weeks. We have nothing more to share at this time.”

Experts are skeptical about the use of Acadia’s new drug due to the fact that it got the approval of the FDA on an expedited basis. The FDA even labeled Nuplazid as a “breakthrough therapy” that showed “substantial improvement” in Parkinson’s patients and people with life threatening illnesses. Since the drug was approved at such a quick pace, experts fear that its vital safety information was not examined thoroughly.

News Medical has explained the steps involved in the re-evaluation of the drug. The FDA is expected to first look at the previous safety data submitted by the pharmaceutical company. Once the review of the reported cases is done, the FDA may change the approval status of the drug. 

Should the drug be deemed unsafe for human use because of its adverse effects, the FDA could ban its circulation on the market. If there isn’t enough evidence to show it is completely safe, the FDA could impose some restrictions and specify the instances when the drug can be used. This could also lead to label changes and inclusion of more warnings on its packaging. 

For now the Nuplazid is still available and the FDA says doctors can still prescribe it to their patients. Once the final verdict is out, that’s when physicians will be notified if they should stop prescribing the Parkinson’s drug to their patients or not.