A study of over 90,000 women.
Lhe EPI-PHARE Scientific Interest Group (GIS) recently published an epidemiological study [1, 2] in the scientific journal Journal of the American Medical Association (JAMA) [3]. The objective was to assess the possible relationship between the dosage of intrauterine devices (IUDs) with levonorgestrel (19.5 mg or 52 mg – cf. framed) and the use of psychotropic drugs (antidepressants, anxiolytics and hypnotics).
This French work, carried out using health insurance reimbursement data, shows a slightly increased, but significant, use of antidepressants in women wearing an intrauterine device (IUD) dosed at 52 mg of levonorgestrel compared with those wearing a 19.5 mg IUD, within 2 years of contraceptive insertion.
Box – List of levonorgestrel IUDs marketed in France
A study of more than 90,000 French women
To conduct this study, the authors included more than 90,000 women aged 13 to 40 with no history of psychotropic use and newly fitted with a levonorgestrel IUD. They were divided into 2 groups:
- 45,736 women who received a levonorgestrel 52 mg IUD (mean age: 32.3 years);
- 45,736 women who received an IUD containing levonorgestrel 19.5 mg (mean age: 31.8 years), corresponding to the control group.
In order to assess the possible relationship between depressive disorders and levonorgestrel dosage, the consumption of psychotropic drugs (antidepressants, anxiolytics and hypnotics) was collected in each group, in the 2 years following the insertion of the IUD.
Conclusions that call for further studies
The authors point out that the risk of depression or the risk of mood disorders (depressed mood) are known adverse effects of hormonal contraception, including the levonorgestrel IUD. These psychiatric adverse effects are mentioned in the information documents (SPC and package leaflet).
As part of their study, they hypothesized that the dose of levonorgestrel might represent a factor influencing the incidence of use of psychotropic drugs, “because low-dose devices may cause low serum progestin levels”.
At the end of this work, of all the psychotropic drugs analysed, only the incidence of antidepressant consumption seems to increase in women carrying an IUD with a higher dose of levonorgestrel (52 mg). On the other hand, the EPI-PHARE study did not show an increase in the use of anxiolytics or hypnotics, whereas other studies suggest this relationship.
Although this study is the first to show a risk of depressive disorders depending on the dose of levonorgestrel contained in an IUD, these new data should be interpreted with caution. “Differences in absolute percentages of antidepressant use are small and unlikely to be clinically relevant at the individual level, but this finding is nonetheless important to consider at the population level and requires further study”conclude the authors.
