duphaston safety in early pregnancy

What do the experts say?

Duphaston (Dydrogesterone) was developed in the 1950s and first became available in the 1960s. This medication, which mimics the naturally-occurring sex hormone progesterone, has, then, been around for a long time now, which has given researchers ample time to study its safety, efficacy, and side effects.

The medication is, in varying doses, prescribed for numerous different medical conditions caused by a progesterone insufficiency — women who are not having periods and those with irregular periods may be prescribed this drug. Duphaston may be prescribed for three reasons that relate to pregnancy directly:

• You are pregnant and your doctor assesses that you are at risk of having another miscarriage after you have already had multiple miscarriages related to a progesterone deficiency.
• You are pregnant and experiencing the symptoms of a threatened miscarriage right now — Duphaston can sometimes save your pregnancy.
• You are unable to conceive due to luteal insufficiency. This means that the lining of your uterus, which needs to function well for a pregnancy to be possible, isn’t growing tay pregnant. Dydrogesterone is meant to make sure that you have enough progesterone.

Does it work? According to the World Health Organization: “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.”

A recent study, published in 2015, likewise concluded that taking Duphaston does not “lead to a significantly higher rate of live births” in women who have already suffered several unexplained miscarriages. Although it is not clear how well Duphaston works for preventing miscarriage, and any positive effect it has may be small, prescribing doctors have to weigh their options and advise you to take the course of action they consider best.

Some women who were prescribed Duphaston were concerned that the drug may not be safe for their growing fetuses. Considering the fact that Duphaston has been in use for many decades now and the sole known risk is hypospadias, a minor birth defect in which the urethra of a baby boy develops in the wrong place (something that can be corrected with surgery), Duphaston is generally considered very safe in pregnancy. The drug was discontinued in several countries for commercial reasons, rather than safety reasons.

That does not mean that Duphaston doesn’t come with the risk of side effects and adverse reactions, or that everyone can take it. The known side effects of this drug — which some people, and certainly not everyone, will experience — include:

• Migraines
• Dizziness
• Abdominal bloating
• Nausea
• Sore breasts
• Skin rashes
• Bleeding between periods

You should not take Duphaston if:

• It was not prescribed to you by a doctor
• You are known to be allergic to any component of the drug
• You have unexplained bleeding between periods
• You have, or are suspected to have, any progesterone-dependent neoplasm (tumor/growth)

It is not recommended for girls under 18 or for breastfeeding women.

The prescription of Duphaston during early pregnancy — and progesterone therapy in general — is more common in some countries than others. The drug seems to be prescribed quite frequently in India, for example. What drug you will be prescribed depends, in part, on what medications are available in your country.

Women who have questions about this drug after being prescribed it can discuss whether it is safe for them (based on known contraindications), and whether the risks outweigh the benefits, with their doctor. The SteadyHealth team would always encourage anyone who has concerns about a medication they were prescribed to take these worries up with their healthcare provider — any good doctor will answer your questions, including questions about safety, alternative medications, and what will happen if you stop taking your medication. If you do not trust your doctor for whatever reason, the route we’d advise is to seek a second opinion from another doctor. We would strongly discourage you from deciding to stop using a medication you were prescribed on your own or changing the dosage on your own. Severe side effects are an exception — if you experience any (suspected) side effect that has you worried for your life or continued long-term wellbeing, head to the emergency room and do not take any more doses of your medication until you receive further instructions from a doctor. as it should, due to a lack of progesterone.