NSAID and Opioid Adverse Event Reports from MedWatch Save

One-third of adults in the USA experience chronic pain and take prescription nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or opioids. This report from the MedWatch system shows that 20% of reports were associated with death, with near equal contribution by NSAIDs, opioids and combination (NSAIDs plus opioids).

With growing concern over the safety of these agents, investigators reviewed data collected between 2015 and 2016 from the FDA’s Adverse Events Reporting System (FAERS or MedWatch) to analyze the comparative frequencies and demographics of those reporting painkiller-related AEs.

Over 2 million adverse event (AE) reports were submitted to FAERS during this period and nearly 3% (64,354) were were associated with painkillers.

Opioid-associated AEs were more likely to be from males or younger patients (mean age 47.6 years). The

The most frequent AEs were from drug ineffectiveness, administration issues, abuse, and overdose associated with NSAID and opioid use.

Death was reported in 20.0% of the reports, and serious adverse reactions (SAE), including death, were reported in two-thirds.

Death and SAEs highest among patients using opioids or combinations users.

Given the great focus on opioid hazards, these data suggest that NSAIDs and combination painkillers may be as hazardous as opioids when looking at FAERS reports.