Reported Adverse Events with Painkillers: Data Mining of the US Food and Drug Administration Adverse Events Reporting System
One-third of adults in the USA experience chronic pain and use a variety of painkillers, such as nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and opioids. However, some serious adverse events (AEs), such as cardiovascular incidents, overdose, and death, have been found to be related to painkillers.
We used 2015 and 2016 AE reports from the US FDA’s Adverse Events Reporting System (FAERS) to conduct exploratory analysis on the demographics of those who reported painkiller-related AEs, examine the AEs most commonly associated with different types of painkillers, and identify potential safety signals. Summary descriptive statistics and proportional reporting ratios (PRRs) were performed.
Out of over 2 million reports submitted to FAERS in 2015 and 2016, a total of 64,354 AE reports were associated with painkillers. Reports of opioid-associated AEs were more likely to be from males or younger patients (mean age 47.6 years). The highest numbers of AEs were reported for NSAID and opioid use, and the most commonly found AEs were related to drug ineffectiveness, administration issues, abuse, and overdose. Death was reported in 20.0% of the reports, and serious adverse reactions, including death, were reported in 67.0%; both adverse outcomes were highest among patients using opioids or combinations of painkillers and were associated with PRRs of 2.12 and 1.87, respectively.
This study examined the AEs most commonly associated with varying classes of painkillers by mining the FAERS database. Our results and methods are relevant for future secondary analyses of big data and for understanding adverse outcomes related to painkillers.
The authors thank the patients, healthcare providers, and others who contribute to the FAERS database and the FDA for making these data publicly available.
Compliance with ethical standards
No sources of funding were used to assist in the preparation of this study.
Conflicts of interest
Jae Min, Vicki Osborne, Allison Kowalski, and Mattia Prosperi have no conflicts of interest that are directly relevant to the content of this study.
- 1.Institute of Medicine. Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington, DC, National Academies Press; 2011. http://www.nap.edu/catalog/13172. Accessed 13 Mar 2017.
- 2.Center for Health Statistics N. National hospital ambulatory medical care survey: 2013 Emergency Department Summary Tables. 2013. https://www.cdc.gov/nchs/data/ahcd/nhamcs_emergency/2013_ed_web_tables.pdf. Accessed 13 Mar 2017.
- 9.Jozwiak-Bebenista M, Nowak JZ. Paracetamol: mechanism of action, applications and safety concern. Acta Pol Pharm Drug Res. 2014;71:11–23.Google Scholar
- 16.US Food and Drug Administration. Reporting serious problems to FDA—what is a serious adverse event? Office of the Commissioner; 2016. https://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm. Accessed 27 Jun 2017.
- 17.US Food and Drug Administration. FDA adverse events reporting system (FAERS)—Reports received and reports entered into FAERS by year. Center for Drug Evaluation and Research. 2014. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm. Accessed 13 Mar 2017.
- 20.Duggirala HJ, Tonning JM, Smith E, Bright R a., Baker JD, Ball R, et al. Data mining at FDA. 2015;1–24. http://www.fda.gov/downloads/scienceresearch/dataminingatfda/ucm443675.pdf. Accessed 27 Jun 2017.
- 22.Hoffman KB, Dimbil M, Erdman CB, Tatonetti NP, Overstreet BM. The weber effect and the united states food and drug administration’s adverse event reporting system (FAERS): Analysis of sixty-two drugs approved from 2006 to 2010. Drug Saf. 2014;37:283–94. https://doi.org/10.1007/s40264-014-0150-2.CrossRefPubMedPubMedCentralGoogle Scholar