4

Dydrogesterone and Dienogest are very very helpful medications in treating endometriosis condition, and Dydrogesterone helps many women to become pregnant. They are widely used around the world and help a lot of women.

But in US Dydrogesterone was discontinued a long time ago. In US women have access to only a single type of progesterone - Norethindrone or Depo Provera, which is not good in helping with endometriosis or infertility. Dydrogesterone, Dienogest, Desogestrel - are not FDA approved. Why so? So many women suffer from endometriosis and Depo Provera (which is usually prescribed) has sooooo many side effects and fertility restored up to 2 years! Norethindrone or Depo Provera are the worst options for women, and they are the only option available in US. Why is it the case? Why Dydrogesterone was discontinued?

2

Not sure about the US case, but for UK I found

Dydrogesterone withdrawn for commercial reasons United Kingdom — Dydrogesterone (Duphaston ®) is to be withdrawn from the market from March 2008 for commercial reasons. Dydrogesterone was licensed for use in several indications, including threatened or recurrent miscarriage, dysfunctional uterine bleeding, and hormone replacement therapy. A Public Assessment Report has reviewed 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.

Reference: Medicines and Healthcare products Regulatory Agency (MHRA) information release.

The verbiage provided by the FDA is a bit more obscure

We have carefully reviewed our files for records concerning the withdrawal of GYNOREST (dydrogesterone) oral tablets, 5 mg and 10 mg, from sale. We have also independently evaluated relevant literature and data for possible post-marketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.

What I read into that is "withdrawn for commercial reasons".

| improve this answer | |
  • I see, sure. lol ... as I thought. Prioritizing commercial reasons over women's health. – YohanRoth Dec 3 '17 at 22:35

Your Answer

By clicking “Post Your Answer”, you agree to our terms of service, privacy policy and cookie policy

Not the answer you're looking for? Browse other questions tagged or ask your own question.