[Hepatitis observed during a treatment with a drug or tea containing Wild Germander. Evaluation of 26 cases reported to the Regional Centers of Pharmacovigilance].
Twenty-six patients developed acute hepatitis after taking Germander, an herbal medicine used to facilitate weight loss. Hepatitis occurred within 9 weeks of treatment and was characterized by jaundice and a high level of aminotransferases. Recovery was obtained between 1.5 and 6 months after withdrawal. In 12 cases, readministration was followed by prompt recurrence of hepatitis. The causal relationship is probable but the mechanism remains unclear: there was no relationship with the daily intake and the duration of treatment; there are no toxicological data on Germander compounds; contamination by an unidentified product is possible but has not been demonstrated. It should be emphasized that readministration of Germander produced recurrence of the hepatitis whenever it was performed. As a result, the French Ministry of Health recently decided to prohibit national-wide all Germander containing medicinal products.
Castot
A
A
Centre de Pharmacovigilance, Hôpital Fernand-Widal, Paris.
Larrey
D
D
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001628:Beverages; D056486:Chemical and Drug Induced Liver Injury / Q000097:blood / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010946:Plants, Medicinal; D013607:Tablets; D015430:Weight Gain / Q000187:drug effects*
D013607:Tablets; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase
Hépatites observées au cours d'un traitement par un médicament ou une tisane contenant de la Germandrée petit-chêne. Bilan des 26 cas rapportés aux Centres Régionaux de Pharmacovigilance.