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PP01-12: Sound the Alarm: Identifying Drug Characteristics Leading to FDA Label Changes

Poster Presenter

      Yoselin Ordonez Suarez

      • Clinical Research Pharmacist
      • VA Cooperative Studies Program
        United States


To analyze drug characteristics that lead to regulatory changes in drug labeling.


FDA Adverse Event Reporting System (FAERS) events were analyzed from 2015-2019. A total of 292 safety signals of adverse events were collected. Drugs@FDA database was used to identify drug approval dates while Advera Health Analytics software was used to determine the number of FAERS cases.


A retrospective analysis was conducted by reviewing FDA Adverse Event Reporting System (FAERS) from 2015-2019. A total of 292 safety signals of adverse events were collected, of which 72 lead to modifications in package labeling. Reported safety signals on medication errors, fetal death, and device malfunction were excluded. Further analysis on events leading to label modification was executed by categorizing label changes, identifying body systems affected by drugs, and determining the diseases affected by drug therapy. Evaluating the 292 safety signals from FAERS, 65% of outcomes are classified as gathering additional data to characterized risk, 24% of signals led to modification of package labeling, and less than 10% of events were labeled as market supervision and no action required. The most common modifications in package inserts as a result of safety data was under the warnings and precautions section followed by adverse reactions and contraindications. The body systems most affected by the reported adverse events include the immune system with (37%), cardiovascular (11%), and integumentary, renal, and nervous systems (8% each). The drugs that raise safety signals in the FAERS system mainly target cancer, diabetes, seizures, hepatitis C and hypercholesterolemia. More than half of the drugs targeting such diseases have been approved from 2012-2015. A total of two boxed warnings were identified that included drugs alemtuzumab for stroke and tramadol for respiratory depression. Alemtuzumab stroke cases included 73 patients and tramadol respiratory depression included 359 cases reported to date. Total number of cases leading to a safety signal varied for each disease and drug.


The safety signals identified by spontaneous reporting and released in the quarterly FDA report of (FAERS) data is a useful tool for clinicians and researchers alike to understand novel safety issues surrounding marketed drugs in the United States. The length of time from safety signal to regulatory action can vary greatly, and thus, it is important that the information contained in such reports be evaluated with all other available data when making clinical decisions. This study identified key indicators of safety signals that are most likely to result in regulatory action. Using an informed decision-making process when reviewing safety signals can allow clinicians to better utilize FDA reports in real time when treating patients with newly identified potential safety risks.

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