Nonselective nonsteroidal anti-inflammatory drug (NSAID) users are at increased risk of gastrointestinal bleeding.
Dr Richard Hunt and colleagues from Canada assessed the pattern and extent of fecal blood loss with ibuprofen.
Ibuprofen in this context is considered to have a favorable gastrointestinal safety profile.
The investigative team conducted a post hoc analysis of 2 separate randomized, parallel-group, double-blind studies.
In these studies, ibuprofen was used as a positive control.
Fecal blood loss was measured by radioactive analysis of chromium-51 labeled red cells in stools during baseline.
The investigators then randomized 68 healthy volunteers to 4 weeks of treatment with ibuprofen 800 mg 3 times daily or placebo.
|Daily mean blood loss was about 4-fold greater with ibuprofen than placebo|
|Clinical Gastroenterology & Hepatology|
Fecal blood loss was considered significant when blood loss was more than 2 mL daily.
The investigators noted that the baseline period was identical for all subjects, with an average fecal blood loss of 0.4 mL per day.
During the study period, all subjects receiving ibuprofen had a daily mean fecal blood loss of more than 2 mL.
The team observed that the group daily mean loss was about 4-fold greater than in the placebo group.
In the ibuprofen group, 26 of 31 subjects had between 1 and 7 random episodes of microbleeding with fecal blood loss more than 3 mL.
The investigators found that 9 had a maximum fecal blood loss of more than 10 mL.
The team noted that in 2 subjects blood loss reached 73 mL and 66 mL, respectively.
Dr Hunt's team commented, “Treatment with a therapeutic dose of ibuprofen, a commonly used nonselective NSAID, in healthy subjects is associated with significant fecal blood loss.”
“This occurs randomly with spikes of bleeding, sometimes exceeding 66 mL in a single day.”
“Chronic anemia or gastrointestinal bleeding in patients taking nonselective NSAIDs should be thoroughly investigated.”