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Ibuprofen most frequent drug-induced liver injury agent in Spain

Ibuprofen is one of the most frequent causative agents listed in the Spanish and Latin-American registries of the Drug-Induced Liver Injury Network, according to a recently published study.

“The risk of developing ibuprofen-induced liver injury is low considering the extensive use of this drug worldwide, but should not be overlooked as it can have life-threatening consequences,” the researchers wrote.

The researchers compared 21 ibuprofen-induced idiosyncratic hepatoxicity cases from the Spanish registry and five from the Latin-American registry with 76 cases caused by other nonsteroidal anti-inflammatory drugs (NSAIDs) and 844 cases caused by non-NSAIDs.

Among the 76 NSAID cases in the Spanish registry, ibuprofen was the causative agent in 29% and diclofenac was the causative agent in 18%. The most common causative agents in the NSAID cases from the Latin-American registry were nimesulide (38%), diclofenac (34%) and ibuprofen (17%).

Additionally, diabetes was more frequent (27% vs. 7-12%; P = .04) among the ibuprofen cases compared with the other NSAIDs and non-NSAIDs. Hypertension was less prevalent (10% vs. 20-29%), though this did not reach significance.

There was no characteristic drug signature for ibuprofen DILI compared with other causative agents and the characteristics of ibuprofen hepatotoxicity varied between patients. According to the researchers, this likely reflects the contribution of host and environmental factors.

“The absence of a distinct drug signature highlights the contribution of individual host and environmental factors in ibuprofen DILI,” the researchers wrote. As over-the-counter ibuprofen is available up to 400 mg in Spain, compared with the maximum OTC dose of 200 mg in the U.S., the researchers question if higher frequency of ibuprofen-related DILI in Spain could be related to dosage. “Nevertheless, genetic differences and variations in pattern of drug use may also contribute to differential ibuprofen frequencies.” – by Talitha Bennett

Disclosure: The researchers report no relevant financial disclosures.