The weekend before, I was involved in a terrifying conversation. My husband and I were attending an event at Central Park, New York, enjoying the evening breeze and talking with guests.
A lady we met recently told us that she worked as a nurse employed in an infertility clinic that her OB/GYN husband ran. I explained what I do and how pleased I was when I learned that Makena had been removed from being sold on.
Makena is a synthetic version of the progesterone hormone. It was granted “fast track” approval by the FDA around ten years ago, as preliminary studies suggested it could aid women in carrying births up to nine months. However, later studies found no benefits to the pregnancy’s duration as it put the mother and the child at risk of adverse side effects.
She looked up, “Makena is off the market? But it’s part of our process.”
I sighed and said, “The FDA determined it has no value. The company has pulled this product off of the marketplace.”
She pondered momentarily before saying, “Oh that’s right, now we use an identical drug made for us by a compound pharmacy.” ( Compounding pharmacies can make similar or even identical medications similar to FDA-approved drugs by starting from scratch. Pharmacy pharmacies can still compound generic versions of Makena as there may be other uses for progesterone. However, they can’t compound both Makena and generics aren’t allowed to be used during pregnancy).
I was astonished and explained to her, ” Progesterone has been shown to have no benefit in maintaining a pregnancy and has a possible link to cancer in young adults exposed in utero.”
“But we’ve been using it for years!” she stated in a confused voice.
I told you, “Doctors used DES, diethylstilbestrol, on pregnant women for years too, causing harm to millions of people.”
My husband intervened, and we both realized I was trying my best to control myself; however, the battle was not a win. Fight. I was furious, IRATE, that professionals within the realm of infertility treatment didn’t know about (A) Makena has been taken off its market due to the FDA (which is a sign of something given how often this occurs) as well as (B) she didn’t seem to believe my claims.
He added, “Su’s mother was given DES, and it made Su infertile.” The tension in the air changed to compassion – what my husband said was real and annoyed me. My prior exposure to DES, an estrogen utilized for identical reasons to Makena, did not explain why Makena was removed from the market.
However, I stopped for a moment in the realization that I’d provided her with the correct information and that pushing it further would not increase the chances of her doing her research and finding me to be accurate. I backed off (hoping to get more flies to bite me with honey rather than vinegar).
“I’m sorry for being so eloquent, but you’re trying to have fun at the night, just like us. I’m sorry, but let me take you off and have a wonderful night.” (Or something similar; listening to myself over the rage buzzing through my head was challenging!)
My husband and I walked off, and I hoped she’d been told how crucial it was to stop taking progesterone in pregnant women.
Preterm births can have catastrophic and lifelong consequences on the baby and parents. Preterm birth poses a significant medical risk that requires the use of a medication that has been proven to work, and that has been shown not to cause harm to the embryo. However, Makena is not that drug. Makena is a relic drug that was once called Delalutin and later Gestiva. Both were taken off the market in the past for the same reason, similar to Makena: they were not tested for effectiveness. They placed both the mother and the baby at risk of unanticipated adverse consequences (just as DES).
When the FDA endorsed Makena, it was accompanied by the condition that within ten years, the company should carry out follow-up studies confirming progesterone’s positive effects on pregnant women. The only research done by the manufacturer did not prove any benefits for preterm births.
Before Makena was removed from the market, the prescription information included potential adverse reactions such as depression, blood clots, gestational diabetes, depression, and reactions at the injection site, and also mentions the possibility of stillbirth as a cause. Makena is a high-risk medication for mothers. A recent study found an increase in the risk of cancer in children exposed to this synthetic hormone during the uterus, which was in line with what was observed with the usage of DES. DES was given to between 5 to 10 million women who were pregnant for the prevention of miscarriage. It was found ineffective and associated with higher rates of breast cancer in girls and mothers exposed, as well as numerous other adverse effects that can lead to fertility problems.
If the lady at the garden celebration is reading this and you’re reading this, I’ll repeat that I am sorry for ruining an enjoyable evening. However, I did it as you and everyone involved in prenatal care should be protecting women, not just “follow protocol.” Women’s prenatal health concerns affect not just the mother, her partner, and the unborn child. It is essential to safeguard everyone from unnecessary risk, especially from long-lasting medications.