FDA re-examining safety of Nuplazid post reports of spike in adverse event

As per a latest report published on CNN, FDA (Food and Drug Administration) has said that it is re-examining safety of Acadia’s Nuplazid, the only approved drug used to treat hallucinations and delusions associated with Parkinson’s disease.

CNN reported that the drug Nuplazid was approved by the agency even though there were concerns that not enough was known about the drug’s risks. CNN also reported earlier this month that the FDA received a spike in “adverse events reports” among those using the drug, including death, but those reports do not necessarily prove that the drug caused the event.

When asked by CNN about what prompted the FDA’s new evaluation of Nuplazid, the agency said the decision was based on a number of factors but wouldn’t say what those factors were. Instead, it would only comment generally, saying that it identifies “potential signals of serious risk/new safety information” in part by using adverse event data and that the agency is not suggesting physicians stop prescribing the drug or take patients off of it while a safety evaluation is taking place.

The FDA has noted that the death reports citing Nuplazid have typically involved elderly patients with advanced-stage Parkinson’s disease who suffered from numerous medical conditions and often take other medications that can increase the risk of death.

But physicians, researchers and other medical experts told CNN that the high number of reports deserved a closer look to determine whether they were related to the drug. They also recommended further testing of Nuplazid, worrying that the drug had been approved too quickly, based on too little evidence that it was safe or effective.

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News Source: https://edition.cnn.com/2018/04/25/health/fda-nuplazid-safety-evaluation-invs/index.html

Image Source: http://www.mblynchfirm.com/pharmaceutical-litigation/nuplazid/