Researchers from Dundee and Edinburgh, Scotland, investigated the association between gastrointestinal hemorrhage and over the counter (OTC) ibuprofen use.
They presented their research at the British Society of Gastroenterology Annual Meeting, held in Birmingham, England.
The excess number of upper gastrointestinal complications (UGIC) requiring hospitalization, which may be expected from the amount of ibuprofen sold for OTC use in 2000 in the UK, was calculated.
Those who had redeemed a prescription for ibuprofen (≤ 1200mg/day, equivalent to the maximum daily dose available OTC) between January 1989 and December 1995 in Tayside, Scotland, and were at low-risk of GI events, were included in the study.
Hospitalization for UGIC was recorded for patients both exposed and not exposed to ibuprofen.
IMS Health (UK) supplied data on the total weight of ibuprofen sold in the UK in 2000.
Assuming the UGIC risk in Tayside was the same as the entire UK, the excess number of UGIC for the estimated OTC use in 2000 was calculated.
|1.3 excess GI events per 1,000,000 population attributable to OTC ibuprofen exposure.
| BSG |
The risk of UGIC whilst exposed to the OTC maximum daily dose of ibuprofen was found to be 1.62 events per 1000 patient years. The risk in those unexposed was 0.85 events per 1000 patient years. Thus, the excess risk was 0.75 events per 1000 patient years.
The team discovered that 46,000 kg of ibuprofen was sold OTC in 2000.
Assuming all usage at the maximum daily dose, 81 UGIC would be attributable to OTC ibuprofen exposure - equivalent to 1.3 events per 1,000,000 population.
Author C. L. Sheen, of the Medicines Monitoring Unit at the Ninewells Hospital & Medical School, Dundee, said on behalf of colleagues, "There is a small estimated excess risk of serious GI events associated with ibuprofen at doses available OTC."
"Ibuprofen, when used at recommended OTC dosages in a low risk population, must be considered very safe," it was concluded.