France, Spain. Six cases of severe cytolytic hepatitis have been reported in the literature in association with the use of the alfa-glucosidase inhibitor, acarbose (Glucobay: Bayer), indicated in diabetes as an adjunct to dietary control. All these cases occurred in women receiving recommended doses of acarbose (150 to 300 mg per day) for durations ranging from 2 to 8 months.

Icterus was present in 4 patients and hepatomegaly was observed in 5 cases. Raised liver enzymes resolved during the months following withdrawal of acarbose. In two patients, reintroduction of acarbose resulted in an increase in liver enzymes after a few days. The data sheet was modified to state that a few rare cases of raised liver enzymes have been observed, as well as isolated cases of icterus and/or hepatitis, which were reversible on withdrawal of the treatment.

[See also Pharmaceuticals Newsletter No. 3, March 1992]

References:

1) La Revue Prescrire Vol. 18, No. 190, p.841, December 1998.
2) Butlletí Groc, Vol. 11, No. 5, p.23 October-December 1998.