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Liver damage from low-dose oral contraceptives
1Medical Clinic, Sahlgrenska University Hospital, Göteborg, Sweden.
Objective:
To study whether the decrease in the content of oestrogen and gestagen in modern low-dose oral contraceptives (OC) has yielded a lower incidence of adverse liver reactions, and to describe the biochemical pattern of the adverse liver reactions from low-dose OC.
Design:
We surveyed all liver reactions from OC reported to SADRAC (Swedish Adverse Drug Reactions Advisory Committee) from 1966 to 1989.
Main Outcome Measure:
Incidence of reported adverse liver reactions (number of reported adverse reactions/OC sales in defined daily dose [DDD]).
Results:
There was a sharp decline in the number of reports during the studied period, suggesting changes in reporting habits. However, there was also a significantly lower incidence of reports for medium-compared to high-oestrogen dose OC, and a further decrease, albeit non-significant, in incidence with low-oestrogen dose OC. Furthermore, in three comparisons of pairs of OC that differed only in the gestagen dose, there was a strong trend towards a higher reporting rate with higher gestagen dose. Cholestatic and hepatocellular liver enzyme patterns were equally frequent in patients with adverse reactions from low-dose oestrogen OC. There was no report of liver tumours related to use of low-oestrogen dose OC.
Conclusion:
There seems to be a decrease in the incidence of adverse liver reactions related to lower contents of both oestrogen and gestagens in OC of the combined-preparation type.
Insights
Lower doses of estrogen and gestagen in oral contraceptives (OC) are linked to fewer adverse liver reactions. This study analyzed liver issues reported with OC use over time.
Area of Science:
- Pharmacology
- Hepatology
- Drug Safety
Background:
- Oral contraceptives (OC) have evolved with reduced hormone content.
- Adverse liver reactions have been associated with older, higher-dose formulations.
- Understanding the safety profile of low-dose OC regarding liver health is crucial.
Purpose of the Study:
- To determine if decreased estrogen and gestagen in modern low-dose oral contraceptives (OC) correlate with a lower incidence of adverse liver reactions.
- To characterize the biochemical patterns of liver injury associated with low-dose OC use.
Main Methods:
- A retrospective survey of all OC-related liver adverse events reported to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC) between 1966 and 1989.
- Calculation of the incidence of reported adverse liver reactions based on OC sales (defined daily dose [DDD]).
Main Results:
- A significant decrease in the incidence of reported liver reactions was observed with medium-dose estrogen OC compared to high-dose formulations.
- Low-dose estrogen OC showed a further, though not statistically significant, decrease in reported liver reactions.
- Higher gestagen doses in OC were associated with a trend towards increased reporting rates of liver adverse events.
- Cholestatic and hepatocellular patterns were equally common in low-dose OC users experiencing liver reactions; no liver tumors were reported.
Conclusions:
- The reduction in both estrogen and gestagen content in combined-preparation oral contraceptives (OC) appears to be associated with a decreased incidence of adverse liver reactions.
- Low-dose OC formulations demonstrate an improved liver safety profile compared to older, higher-dose versions.