Terfenadine and risk of acute liver disease.
OBJECTIVE
To estimate the risk of idiopathic acute liver disease among users of terfenadine.


METHODS
We conducted a population-based cohort study based on the General Practice Research Database (GPRD) in the U.K. All persons who received at least one prescription for terfenadine during the period 1991 through 1995 were eligible for the study. Among these patients we identified all those with a diagnosis of a liver disorder requiring hospitalization or referral to a consultant within 60 days of a prior prescription for terfenadine. We obtained clinical records, including hospital discharge summaries, consultant reports and relevant laboratory results in order to identify a potentially drug-inducible liver illness.


RESULTS
From a cohort of 210683 recipients of terfenadine, we found only three cases of acute liver disease where a causal connection to terfenadine could not be ruled out, yielding a risk estimate of 1.4/100000 users (95% CI 0.5, 4.2) and 0.5/100000 prescriptions (95% CI 0.2, 1.4). All cases were receiving a concomitant hepatotoxic drug and all had a full recovery.


CONCLUSIONS
The use of terfenadine is rarely associated with idiopathic acute liver disease.
The Boston Collaborative Drug Surveillance Program, Boston University Medical Center, Lexington, MA 02173, USA.
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D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D056486:Chemical and Drug Induced Liver Injury; D015331:Cohort Studies; D019992:Databases as Topic; D005260:Female; D006634:Histamine H1 Antagonists / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012042:Registries; D012307:Risk Factors; D016593:Terfenadine / Q000009:adverse effects*
D006634:Histamine H1 Antagonists; D016593:Terfenadine