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JANUARY 22, 2018

Safety Concerns Raised for 2 Novel Agents

The postmarketing safety record of two recently approved dru gs with novel mechanisms of action has raised concerns, leading investigators to examine how these agents got approved in the first place, according to a report by the Institute for Safe Medication Practices (ISMP).

ISMP issued safety alerts for pimavanserin (Nuplazid, ACADIA Pharmaceuticals) and the combination of sacubitril and valsartan (Entresto, Novartis) following reports of adverse event (AE) data “warranting careful