Desogestrel is a oral contraceptive, marketed in some countries as a single ingredient, whereas it is only used in fixed-dose combination products together with ethinylestradiol in other parts of the world.
Desogestrel achieves its contraceptive effect primarily by the inhibition of ovulation. Other effects include increased viscosity of the cervical mucus and decreased oestradiol levels, to one corresponding to the early follicular phase.
A total 53 individual case safety reports received in vigibase with events of night sweats, vulvovaginal dryness and dry eye for desogestrel. There are 20 desogestrel – night sweats reports with 14 positive dechallenges, 22 desogestrel – vulvovaginal dryness reports with 12 positive dechallenges and 15 desogestrel – dry eye reports with 7 positive dechallenges.
The reports, mostly provided by consumers, involve women 22 to 50 years old, where desogestrel was usually the only drug reported. Few reports provided any other possible explanation for the reactions. Several consumers described a significant negative effect on quality of life and noticeable improvement when discontinuing desogestrel. These three adverse drug reactions are already included in descriptions of some other contraceptives, but not for desogestrel, therefore it was considered as signal.
Source: WHO newsletter
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