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A recent regulatory review of a controversial Parkinson’s drug may not have found any new or unexpected safety findings, but a nonprofit watchdog argues the assessment was insufficient and the Food and Drug Administration should reconsider its approval.

In its report, the Institute for Safe Medicine Practices maintained that an FDA review issued last fall “provides no new reassurance that the benefits of (Nuplazid) outweigh its risks. Instead, the post-market data and new study warrant increased concern.” At the very least, the nonprofit argues the FDA should issue a warning that the drug may “substantially increase patient deaths.”

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