This article is more than 5 years old. Information may no longer be current.
Amoxicillin-Associated Diarrhea, Candidiasis may be Underreported
Click Here to Manage Email Alerts
Diarrhea and candidiasis were associated with amoxicillin, but incidence was poorly reported, indicating a higher true rate of adverse events linked to the common antibiotic, according to recent study data.
Christopher Del Mar
“The root cause of antibiotic resistance is the overuse of antibiotics, and therefore these drugs should not be prescribed when the benefits do not outweigh the harms,” Christopher Del Mar, MD, from the Center for Research in Evidence-Based Practice at Bond University, Australia, said in a press release. “The important consequence of underreporting of harms is the tilting of the balance of benefits and harms toward amoxicillin.”
Aiming to quantify the common adverse events associated with the most commonly prescribed antibiotic, Del Mar and colleagues performed a systematic review of placebo-controlled trials of amoxicillin or amoxicillin-clavulanic acid prescribed for a variety of indications published between 1977 to 2013. Forty-five trials involving 10,519 children and adults met inclusion criteria for qualitative analysis (27 involving amoxicillin, 17 involving amoxicillin-clavulanic acid and one involving both). However, only 56% of the studies reported adverse events sufficiently enough for meta-analysis.
Diarrhea was associated with amoxicillin-clavulanic acid (OR=3.3; 95% CI, 2.23-4.87) and candidiasis was associated with amoxicillin (OR=7.77; 95% CI, 2.23-27.11). The numbers needed to harm was 10 (95% CI, 6-17) courses of amoxicillin-clavulanic acid for diarrhea and 27 (95% CI, 24-42) courses of amoxicillin with or without clavulanic acid for candidiasis.
“Reported harms were fewer than we expected from clinical anecdotal experience and observationally derived data, which have primarily reported common harms as rashes (at rates of 5% [to] 8% of those treated and even higher, up to 20% among those with mononucleosis treated with amoxicillin) and gastrointestinal disturbance,” the researchers concluded. This study “highlights that the ability of clinicians and patients to make fully informed decisions about using amoxicillin and amoxicillin-clavulanic acid is hampered by poor measurement and reporting,” they added.
Yoon Kong Loke
In a related editorial, Yoon Kong Loke, MD, MBBS, and Katharina Mattishent, MBBS, both from Norwich Medical School, University of East Anglia, United Kingdom, wrote that, “Intriguingly, amoxicillin monotherapy was not associated with significant harm (such as diarrhea, rash or nausea), whereas amoxicillin-clavulanic acid was associated with a significant increase in the risk of diarrhea.
“The analyses … highlight the contentious matter of reporting adverse events, which is in need of considerable improvement,” they wrote, adding that it “lends weight to the growing call for full transparency, rather than restricted access and selective release of trial data.”
For more information:
Gillies M. CMAJ. 2014;doi:10.1503/cmaj.140848.
Loke YK. CMAJ. 2014;doi:10.1503/cmaj.141344.
Disclosure: See the study for a full list of relevant financial disclosures. Loke and Mattishent report no relevant financial disclosures.