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Makena Off The Market
This past weekend I had a horrifying conversation. My husband and I were at a garden party in Central Park, New York, enjoying the early evening breeze and chatting with other guests.
A woman we just met mentioned she was a nurse, working in an infertility clinic run by her OB/GYN husband. I mentioned what I do and how happy I was that Makena was now off the market.
Makena, a synthetic progesterone hormone, was given “fast track” approval by the FDA about ten years ago because early studies indicated it might help women carry births to the full term of nine months. However, larger studies later showed no benefit to the pregnancy’s length, and instead put both the mother and child at greater risk from harmful side effects.
She blinked, “Makena is off the market? But it’s a standard part of our protocol.”
I shrugged and said, “The FDA determined it has no benefit. The company has taken it off the market.”
Identical Drug To Makena
She hesitated and then said, “Oh that’s right, now we use an identical drug made for us by a compound pharmacy.” (Compounding pharmacies can create similar or identical drugs to FDA-approved drugs from scratch. Pharmacies can still compound a generic version of Makena because there could be other uses for progesterone, but both Makena and generics are not approved any longer for use in pregnancy).
I snapped to attention and told 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 said, sounding confused.
I said, “Doctors used DES, diethylstilbestrol, on pregnant women for years too, causing harm to millions of people.”
My husband stepped in, as we both knew I was doing my best to contain myself, but it was a losing battle. I was irate, IRATE, that a professional in the field of infertility care did not know that (A) Makena has been pulled off the market by the FDA (which should mean something considering how rarely that happens), and (B) She didn’t seem to believe me.
He said, “Su’s mother was given DES, and it made Su infertile.” The tension in the air changed to sympathy – what my husband said was both true and kind of irritated me. My personal prenatal exposure to DES, an estrogen used for essentially the same reasons as Makena, was not why Makena was off the market.
But I took a breath, realizing I’d given her the information she should have and pushing further would not increase the chance that she’d do her research and agree with me. I backpedaled (hoping that I could catch more flies with honey than vinegar).
“I’m sorry to be so emphatic, you’re just here trying to enjoy the party, like us. I apologize, let me let you go and have a great evening.” (Or something like that, it was hard to hear myself through the frustration buzzing in my brain!)
My husband and I wandered away, me desperately hoping she’d heard how important it was to stop using progesterone on pregnant women.
Preterm birth can have devastating and often life-long effects on the newborn and the parents. Preterm birth is a serious medical risk that deserves a medicine that is proven to work and proven to not harm the fetus. Unfortunately, Makena is not that drug. Makena is an old drug, which was previously known as Delalutin and then Gestiva. Both were removed from the market years ago for the same reason as Makena: they were never proven to work and put both mother and baby at risk for unforeseen side effects (just like DES).
When Makena was approved by the FDA it was with the requirement that within ten years the company would complete follow up studies confirming the benefit giving progesterone to pregnant women. The single study produced by the manufacturer could not show any improvement in preterm births.
Possible Adverse Effects of Makena
Even before Makena was taken off the market, Makena’s prescribing information already listed possible adverse effects including depression, blood clots, gestational diabetes, and injection site reactions, and even notes a possible link to stillbirth. Makena is a high risk drug for the mother. A recent study showed increased risks for cancer in children who were exposed to this synthetic hormone in-utero, echoing what was seen with the use of DES. DES was prescribed to between five and 10 million pregnant women for prevention of miscarriage. It was proven to not work and linked with higher rates of breast cancers in the mothers and daughters exposed and many other adverse effects, sometimes leading to infertility.
If the woman at the garden party is reading this now, let me say again, I’m sorry for spoiling a lovely evening. But I did it because you, and everyone in the prenatal care world, have to protect women, not just “follow protocol.” Women’s health care in pregnancy affects not only the woman and her partner, but her unborn child. We need to protect all of them from unnecessary risk, especially from such long-impacting medications.
I’ve heard and read many healthcare professionals state that “Makena is all they have to give women hope.” Intangible hope turns to everlasting regret when harm is done with no benefit.
There is something tangible that can lower the rates of preterm births and help women have better, healthier birth outcomes: in-home prenatal care. A study in the Journal of the American Medical Association (JAMA) reported in a well-designed study that home-visiting programs improved prenatal and postnatal care, and resulted in lower rates of adverse birth outcomes.
Personal and caring attention to a pregnant woman’s needs goes a lot further than a “magic pill” that, at best, does nothing more than offer false hope, and doctors who don’t read research on the drugs they dispense. Medical experts claim it takes 17 years for new research to be incorporated into clinical practice. If you are considering fertility treatment or if you are pregnant and at risk of preterm birth, protect yourself and your fetus by refusing to take Makena or progesterone if offered. And then find a new doctor who respects the guidelines of the FDA.
