FDA announces Nuplazid isn’t subject to “new or unexpected safety findings”

Following a safety review, the FDA have announced that the drug Nuplazid isn’t subject to any “new or unexpected safety findings”. However, they did find that there were some potentially problematic practices when it came to prescribing the drug, which is often used to treat psychosis in patients suffering from Parkinson’s disease. After its introduction to the market in 2016, there have been hundreds of reports of deaths, which it was suspected were caused by the medication.

Currently, Nuplazid is the only medication that has been approved by the FDA to treat hallucinations and delusions caused by Parkinson’s disease psychosis. At the time of its release, there were multiple reports of “adverse events”. It was feared that the drug had been approved too quickly and with insufficient evidence on its safety. This prompted calls for further testing, which then led to a review being carried out.

The initial medical review was led by Dr Paul Andreason, who is a physician. He warned that as the drug was approved by the FDA, the clinical trials were showing mixed results, including some serious outcomes, and in some cases, death. He said those taking it had twice the risk than those taking a placebo. But the FDA argued that the benefits of the drug outweighed these risks. There’s a lack of safe alternatives, and the Nuplazid has shown to improve the symptoms of a significant number of patients.

Because Nuplazid was initially hailed as a “breakthrough therapy” and showed “sustanstial improvements” in patients symptoms compared to other treatments, the review was put off by the agency. There were some concerns from patients’ relatives that the drug had contributed to their decline or death; although some said they had seen an improvement in symptoms with very few side effects. The FDA said it believes that most of these deaths were in patients with advanced-stage Parkinson’s, or who suffered from other medical conditions.

Now that the safety review has been completed by the FDA, it says: “Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of Nuplazid for Parkinson’s disease psychosis.” They added that like other antipsychotic drugs, Nuplazid has a “black box” warning. This warns patients of the higher risks of death in elderly patients suffering from dementia.

Additionally, the review found that there could be other concerns over how the drug is prescribed. The FDA said that during the review, it found “potentially concerning prescribing patterns”. For instance, some patients were being prescribed Nuplazid alongside other antipsychotic drugs, or in combination with other drugs that are known to trigger heart problems. Therefore, they said it’s essential for health workers to be aware of the risks, and to take precautions accordingly.

Chief executive of the drug’s manufacturer, Acadia Pharmaceuticals said in a statement: “Nothing is more important to Acadia than the wellbeing of the patients who use Nuplazid. We are very pleased with the FDA’s clear statement reaffirming Nuplazid’s positive benefit-risk profile.”

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