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Drug safety evaluation of desogestrel.

Expert opinion on drug safety (2013-04-09)
Carolina Scala, Umberto Leone Roberti Maggiore, Valentino Remorgida, Pier Luigi Venturini, Simone Ferrero
ABSTRACT

Desogestrel (DSG) is a third-generation progestin. It is commonly used in various formulations for hormonal contraception including combinations with ethinyl estradiol (EE), progestin-only pill and subdermal implants. DSG is also used in menopausal patients for hormone replacement therapy (HRT). The current manuscript aims to review the available data on safety and tolerability of DSG in oral contraception and HRT. The material included in the manuscript was searched and obtained via Medline, PubMed and EMBASE up to September 2012 using the search terms 'adverse events, side effects, tolerability' in combination with 'desogestrel and progestins'. DSG is frequently used as contraceptive and it shows good contraceptive efficacy as demonstrated by the Pearl indexes reported in the studies reviewed in this manuscript. It is a versatile compound; in fact, it can be used either as progestin-only contraceptive or in combination with EE, and different formulations are available (such as the subdermal implant). In contraception, DSG is generally well tolerated but its use is associated with doubled risk of venous thromboembolism compared to second-generation progestins. Although DSG is efficacious in HRT, it may not represent the best choice due to the potential higher risk of breast cancer compared with progesterone or dydrogesterone.

MATERIALS
Product Number
Brand
Product Description

Desogestrel for system suitability, European Pharmacopoeia (EP) Reference Standard
Desogestrel, European Pharmacopoeia (EP) Reference Standard