WHO Pharmaceuticals Newsletter 1999, No. 01&02
(1999; 16 pages)
Table of Contents
Open this folder and view contentsRegulatory actions
Close this folderDrug surveillance
View the documentAcarbose: hepatitis: France, Spain
View the documentCorticosteroid-induced osteoporosis: guidelines available: UK
View the documentHydroxycarbamide: leg ulcers: review: France
View the documentMeasles/mumps/rubella (MMR) vaccine: no evidence of link with inflammatory bowel disease and/or autism: Ireland
View the documentMercury compounds: call for data: USA
View the documentNefazodone: review of adverse reactions: Australia
View the documentOndansetron: chest pain: Australia
View the documentPsorigon skin products: update: further analysis confirms tretinoin content: Germany
Open this folder and view contentsNew developments
Open this folder and view contentsGeneral information
Open this folder and view contentsMedication errors
Open this folder and view contentsVeterinary medicine
 

Acarbose: hepatitis: France, Spain

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.

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