Key result
SSRI use increased the risk of upper gastrointestinal haemorrhage (OR 2.36; 95% CI 1.44-3.85), which further increased with concomitant NSAID use (OR 6.33; 95% CI 3.40-11.8).
Why the study?
Does the use of SSRIs, alone or in combination with NSAIDs, increase the risk of upper gastrointestinal haemorrhage?
Meta-Analysis (n=153,000)
Does the use of SSRIs, alone or in combination with NSAIDs, increase the risk of upper gastrointestinal haemorrhage?
Odds Ratio: 2.36 (95% CI 1.44–3.85)
p-value: p=0.0006
SSRI use significantly increases the risk of upper gastrointestinal bleeding, an effect that is markedly amplified when combined with NSAIDs.
BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs) have been associated with upper gastrointestinal haemorrhage (UGIH) but the magnitude and characteristics of this reaction and possible interaction with concurrent Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy are unknown. AIM: To evaluate systematically the risk of UGIH with SSRIs, including interaction with NSAIDs. METHODS: We searched PubMED, Science Citation Index, and trial registries for data on SSRIs, NSAIDs and UGIH. We evaluated spontaneous case reports from pharmacovigilance databases. RESULTS: Random effects meta-analysis of four observational studies involving 153 000 patients showed an odds ratio of 2.36 (95% CI: 1.44-3.85; P = 0.0006) for SSRI associated UGIH. The odds ratio increased to 6.33 (95% CI: 3.40-11.8; P < 0.00001) with concomitant NSAIDs. In patients aged above 50 years with no UGIH risk factors, the Number-Needed-to-Harm per year is 411 for SSRIs alone, and 106 with concomitant NSAIDs. Analysis of 101 spontaneous reports showed that UGIH occurred after a median of 25 weeks with SSRIs. Around 67% of these patients were on NSAIDs. CONCLUSIONS: Selective serotonin reuptake inhibitor use, alone and in combination with NSAIDs, substantially increases the risk of UGIH. Clinicians should consider this when managing patients at risk of, or presenting with UGIH.
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Loke et al. (2007) conducted a meta-analysis in upper gastrointestinal haemorrhage (UGIH) (n=153,000). Selective serotonin reuptake inhibitors (SSRIs) vs. No SSRI use was evaluated on upper gastrointestinal haemorrhage (UGIH) (OR 2.36, 95% CI 1.44-3.85, p=0.0006). SSRI use increased the risk of upper gastrointestinal haemorrhage (OR 2.36; 95% CI 1.44-3.85), which further increased with concomitant NSAID use (OR 6.33; 95% CI 3.40-11.8).
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