JMCP Research Highlight: Research Finds Overall Increase in Trend of Serious ADE Reports from 2006 to 2014


Alexandria, Va., July 5, 2018 — Research published in the July issue of the Journal of Managed Care & Specialty Pharmacy (JMCP) finds that a 2-fold increase in serious adverse drug events (ADE) reports was observed from 2006 through 2014.

Study: “Serious Adverse Drug Events Reported to the Food and Drug Administration (FDA): Analysis of the FDA Adverse Event Reporting System (FAERS) 2006-2014 Database” (July 2018 JMCP)

What is already known about this subject: Each year more than 770,000 people are injured or die from adverse drug events (ADEs); According to a previous study, from 1998 to 2005, there was a 2.6-fold increase in the reports of serious ADEs.

What this study adds: A 2-fold increase in serious ADE reports was observed from 2006 through 2014, which was similar to a previously reported increasing trend in serious ADE reports from 1998 to 2005; Study found that 13 biologic or specialty drugs were connected with 1,000 reports of serious ADEs in a given year during 2006-2015.

Conclusion: An overall increase in the trend of the number of serious ADE reports was observed from 2006 to 2014. Drugs with an FDA risk evaluation and mitigation strategies (REMS) program, and biologic and specialty drugs, were involved in a significant number of reported serious ADEs. Data on reporting patterns can guide surveillance and pharmacoepidemiological studies to understand the public health burden of serious ADEs.

JMCP is the official journal of the Academy of Manage Care Pharmacy (AMCP). Read article at

About JMCP
The Journal of Managed Care & Specialty Pharmacy publishes peer-reviewed original research manuscripts, subject reviews, and other content intended to advance the use of the scientific method, including the interpretation of research findings in managed care pharmacy. It is dedicated to improving the quality of patient care by providing its readers with the results of scientific investigation and evaluation of clinical, health, service, and economic outcomes of pharmacy services and pharmaceutical interventions, including formulary management.