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[Hepatic cytolysis caused by tocolytic treatment using micronized natural progesterone]
G Magnin1, J B de Meeus, R Sarfati
1Service de Gynecologie-Obstetrique, Service de Pharmacovigilance, CHU de Poitiers.
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.
Insights
Micronized natural progesterone, used for preterm labor, may cause drug-induced hepatitis, primarily presenting as pruritus. Healthcare providers should exercise caution due to potential liver risks and unproven effectiveness.
Area of Science:
- Hepatology
- Pharmacology
- Obstetrics
Background:
- Micronized natural progesterone is frequently used in France for preterm labor, often combined with beta-agonists.
- Its efficacy in preventing premature delivery and reducing perinatal complications remains unproven.
Observation:
- Four cases of drug-induced hepatitis were observed in patients receiving micronized natural progesterone.
- Pruritus was the predominant symptom of liver injury.
Findings:
- Hepatitis symptoms, including elevated transaminases, persisted for a week post-discontinuation before resolving within 10-30 days.
- The causal link between micronized natural progesterone and hepatitis was deemed likely.
Implications:
- Clinicians should be aware of the potential hepatotoxicity of micronized natural progesterone.
- Careful monitoring is advised, especially in patients experiencing pruritus, given the drug's unproven benefits.