Most Safety Signals Reported to FDA Lead to Regulatory Action

THURSDAY, Oct. 6, 2022 (HealthDay News) -- Most potential safety signals identified from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) led to FDA regulatory action, according to a study published online Oct. 5 in The BMJ.

Meera M. Dhodapkar, from Yale University in New Haven, Connecticut, and colleagues identified safety signals from the FAERS reported between 2008 and 2019 and reviewed relevant literature published before and after safety signals were reported in 2014 to 2015.

The researchers identified 603 potential safety signals from the FAERS from 2008 to 2019; 68.5 percent were resolved as of December 2021. Of the resolved safety signals, 22.0 and 78.0 percent led to no regulatory action and resulted in regulatory action, respectively, including 77.2 and 14.3 percent with changes to drug labeling and drug safety communications or other public communications from the FDA, respectively. For a subset of 82 potential safety signals reported in 2014 to 2015, 1,712 relevant publications were identified in a literature search. Overall, 76 of the 82 safety signals were resolved; relevant published research and relevant Sentinel Initiative assessments were available for 57 and four signals, respectively. For 17 of the 57 resolved safety signals, regulatory actions by the FDA were corroborated by at least one relevant published research study; FDA regulatory action did not corroborate any of the relevant Sentinel Initiative assessments.

"These findings suggest that either the FDA is taking regulatory actions based on evidence not made publicly available or that more comprehensive safety evaluations might be needed when potential safety signals are identified," the authors write.

Several authors disclosed financial ties to law firms, including one involved in a qui tam suit against Biogen.

Abstract/Full Text

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