title: [Hepatic cytolysis caused by tocolytic treatment using micronized natural progesterone].
abstract: Micronized natural progesterone is often prescribed alone or in association with beta-agonists in the treatment of preterm labor in France. We observed drug-induced hepatitis in 4 such patients. The main manifestation of liver disease was pruritus. After drug withdrawal, elevated transaminase levels continued to rise for one week then normalized within 10 to 30 days. The imputability of this undesirable effect was assessed and considered to be likely. The effectiveness of micronized natural progesterone in the prevention of premature delivery and in decreasing perinatal mortality and morbidity has not yet been proven. This drug should therefore be used with care, keeping in mind the risk of hepatitis, particularly in patients presenting with pruritus.
authors: Service de Gynecologie-Obstetrique, Service de Pharmacovigilance, CHU de Poitiers.
authors: G
authors: G
authors: Magnin
authors: J B
authors: JB
authors: de Meeus
authors: R
authors: R
authors: Sarfati
authors: O
authors: O
authors: Chaouchi
authors: A
authors: A
authors: Paillat
mesh_terms: D000328:Adult; D056486:Chemical and Drug Induced Liver Injury / Q000201:enzymology / Q000209:etiology*; D005260:Female; D006801:Humans; D011247:Pregnancy; D011272:Pregnancy, Multiple; D011374:Progesterone / Q000009:adverse effects* / Q000627:therapeutic use; D013997:Time Factors; D015149:Tocolytic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000637:Transaminases / Q000032:analysis
chemical_list: D015149:Tocolytic Agents; D011374:Progesterone; D000637:Transaminases
vernacular_title: Cytolyse hépatique lors d'un traitment tocolytique par la progestérone naturelle micronisée.