A new progesterone medication can help prevent miscarriage in women who experience unexplained bleeding in their first trimester.
The TGA has registered its first medication for reducing the risk of early pregnancy loss for women at high risk of miscarriage.
The micronised progesterone pessary (Utrogestan) is already approved for women who require extra progesterone while undergoing fertility treatment and for prevention of preterm birth in women with a short cervix. It is already listed on the PBS for these indications.
Last month, the TGA extended its indications for the progesterone pessary to be used in the management of women with unexplained first-trimester bleeding and a history of three or more miscarriages.
It is not yet PBS-listed for this indication but GPs can prescribe it on a private prescription for an out-of-pocket cost to the patient of around $9 per day or $90 per box.
Around one in three women who experience unexplained bleeding in early pregnancy will have a miscarriage, and women who have lost two or more pregnancies are at much higher risk of subsequent miscarriage.
The regulator also said its use may be warranted for women with a history of fewer than three miscarriages but a reduced chance of future pregnancy.
Treatment with the medication can commence at the first sign of bleeding during the first trimester and continue through to week 16.
Contraindications included severe hepatic dysfunction and missed ectopic pregnancy.
No significant adverse effects were noted during clinical trials.
