FDA to re-evaluate the safety of Nuplazid

The FDA have announced that they will be re-assessing the safety of the drug Nuplazid. Nuplazid is currently the only drug that has been approved in the US to treat the hallucinations and delusions associated with Parkinson’s disease psychosis. Medical campaigners have been calling for the drug to be looked at for some time, claiming that it was approved by the agency despite not enough being known about the potential risks.

In light of these concerns, FDA Commissioner Scott Gottlieb has now told members of Congress that the agency would “take another look” at the safety of the drug. The FDA said it won’t disclose the exact reasons for the investigation, however it hinted that there were  “potential signals of serious risk/new safety information”.

According to doctors, carers and other medical professionals, Nuplazid is the suspected cause of hundreds of deaths. Although the FDA has acknowledged these deaths, it noted that they were typically seen in elderly patients who were in the advanced stages of Parkinson’s disease. They also argue that most of the patients suffered from other medical conditions, and were taking other medications that could increase the risk of death.

The initial review of Nuplazid was expedited by the FDA. This was because the agency has designated it as a “breakthrough therapy” which can show “substantial improvement” in the symptoms of patients with life threatening diseases when compared to alternative treatment options. But medical experts have urged that the high number of deaths should be investigated to ensure it’s safe to use.

It’s also been recommended that Nuplazid should be retested, based of the fast speed at which it was first approved. US Rep. Rosa DeLauro commented: “How many more adverse events do we have to have reported? How many people, quite frankly, have to die? Why does the industry always take precedence over public health and safety?”

Following the recent hearing, the FDA has agreed to re-assess the safety of the drug, and has already started the safety evaluation process. Once this is complete, they will use the information to assess the potential risk of harm to patients. They say that appropriate action will then be taken, which could include measure like changing the labelling, restricting its use or taking it off the market altogether.