Prescription Acetaminophen Ingestions Associated with Hepatic Injury and Death

Richard M. Martinez, Sean Patrick Nordt, F. Lee Cantrell

The U.S. Food and Drug Administration has formally requested that pharmaceutical manufacturers limit the amount of acetaminophen (APAP) in prescription products. The goal of this study was to describe a state-wide poison control system's experience with prescription APAP ingestions that resulted in hepatic injury or death. Retrospective analysis of statewide California Poison Control System electronic database for cases from the years 2000 through 2009. Inclusion criteria: adults ≥18 years of age following therapeutic use of an acetaminophen-containing prescription with laboratory evidence of liver injury. Forty cases met the inclusion criteria. All cases involved at least two concurrent acetaminophen-containing products. Prescription APAP strengths of 500 mg per tablet or greater were involved in 32 of 40 cases (80 %). Thirty patients survived, three died, one underwent liver transplantation and seven cases were lost to follow up. The ingestion of concentrated prescription APAP-containing medications in combination with other sources of APAP can result in severe liver injury and death. Limiting the amount of APAP from prescription medications in conjunction with enhanced prescriber and patient education regarding the hazards of ingesting multiple APAP-containing products may assist in decreasing the overall incidence of unintentional APAP poisonings in the United States. Future prospective studies are required to determine if these measures will have a significant impact on both the morbidity and mortality associated with APAP administration.