New meta-analysis reaffirms safety profile of aspirin for pain relief, fever

A new meta-analysis published this week in Drugs in R&D, reaffirms the safety profile of aspirin for short-term treatment of mild to moderate pain, and aches and fever due to colds when used as directed.  The analysis of 67 clinical trials of aspirin for pain relief/fever reduction – the largest conducted to date – encompassed more than 20 years of research and involved mostly single-dose treatment of acute pain.  Patient-reported data showed very few serious gastrointestinal (GI) side effects or other complications associated with aspirin when used in apparently healthy, non-elderly populations without known risk of GI complications.  Findings showed there was only one additional GI adverse event for every 111 patients treated with aspirin compared to placebo (9.9 vs. 9.0 percent, p<0.01).  Findings are consistent with those reported in previous published analyses.  In addition, no significant differences in GI adverse events were seen with aspirin compared to ibuprofen, or with aspirin compared to acetaminophen.

"Aspirin has been life-tested by generations, yet misperceptions regarding its safety when used short-term may be overestimated today.  The results of this new analysis in apparently healthy non-elderly people are reassuring for both healthcare providers and the millions of people who take aspirin, for the most part single-dose, for short-term relief of pain, fever and pain symptoms associated with colds," said Dr. Angel Lanas, University of Zaragoza, and lead author.  "In our extensive meta-analysis, there was a low incidence of patient-reported adverse events, including major GI complications, and a virtual absence of non-GI complications associated with doses and duration of aspirin commonly used for relieving pain, fever or the pain symptoms of colds."

Results of the individual patient-level meta-analysis showed that the overall risk of GI-related adverse events from aspirin, as reported by study participants, was low, with a small, but statistically increased risk of dyspepsia, or upset stomach, when compared to placebo.  Serious GI adverse events were very few (one with aspirin vs. three with placebo), and no differences were found for non-GI adverse events.  Additionally, no cases of cerebral hemorrhage were reported.  

"This extensive analysis reaffirmed the safety profile of single-dose aspirin when used to relieve short-term conditions, such as pain, fever and the pain symptoms of colds," said Wes E. Cetnarowski, M.D., Senior Vice President, Bayer Global Research and Development, Bayer HealthCare.  "With this new information, consumers and healthcare providers can be even more confident that the aspirin they trust is a safe, as well as effective and low-cost way to obtain relief."