Duphaston/Duphaston HRT (dydrogesterone): Efficacy in maintenance of early pregnancy and withdrawal of Marketing Authorisation for commercial reasons

The February issue of Drug Safety Update published today communicates that Duphaston/Duphaston HRT (dydrogesterone) is to be withdrawn from the market from March 2008 for commercial reasons.

Duphaston was licensed for use in several indications, including threatened or recurrent miscarriage, dysfunctional uterine bleeding, and hormone replacement therapy.

A Public Assessment Report available for download below reviews evidence for the efficacy of progesterone and dydrogesterone in the maintenance of pregnancy in women with threatened miscarriage or recurrent miscarriage.

For several decades, progesterone and progestogens (such as dydrogesterone) have been used to maintain early pregnancy. However, this practice seems to have been based on theoretical considerations rather than robust evidence of efficacy. Although the methodological and ethical difficulties associated with conducting efficacy trials in these indications need to be considered, the quality of much of the evidence is generally poor relative to today’s standards.