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Makena: Understanding the Rise and Fall of an FDA-Approved Drug for Premature Birth Prevention

The brand name Makena, earlier known to prevent premature birth has now been discontinued in the United States. What could be the reason Let’s delve into this article to understand what Makena is, its role in preventing premature birth, and why, despite initial FDA approval, the drug’s approval was later withdrawn.

What is Makena?

Makena is a form of progestin, which is a manmade or synthetic form of progesterone or the female hormone. Covis Pharma is the drug maker of Makena. This drug has been in use for lowering the risk of premature birth in women who already had one premature baby. However, it should be noted that Makena cannot stop premature labor that has already started. Moreover, it is also not of any use for women who are pregnant with more than one baby (such as twins, triplets, or more).

Note: Hydroxyprogesterone, another compound, can also be used for this purpose, but it is not an ingredient in Makena.

Makena is injected under the skin or can also be injected into a muscle. The injection will be given by a doctor. At first, the injection is generally given during the second trimester of pregnancy. The general dosing schedule for Makena is one injection every week until the 37th week of pregnancy or until childbirth. You should follow the instructions given by your healthcare provider and visit them for regular checkups without missing any scheduled appointments.

Can it Prevent Premature Birth?

Makena at first gained approval from the Food and Drug Administration (FDA) for sale in 2011 and this was largely based on findings from a study conducted in 2003, sponsored by the National Institutes of Health.(1)

This study included 463 pregnant women who had previously had preterm delivery and were thus considered at increased risk for another premature childbirth. These participants were divided into two groups, one of which received progesterone and the other group received a placebo. 

Women in the progesterone group received weekly injections of Makena starting at 16 weeks to 20 weeks of their pregnancy and continuing until 36 weeks. This study found that treating women with progesterone significantly reduced the risk of preterm delivery before 37 weeks of gestation.

It was thought that progesterone could have acted as a uterine muscle relaxant, which seemed to reduce the ability of the uterus to contract, and thus prevent premature birth.

With this study, the medication was fast-tracked through the approval process of the FDA. However, the manufacturer of Makena was required to do a larger follow-up study for confirming the benefits of the medication.

But, this time the findings did not turn out well. The follow-up study, which was published later, found that Makena could not decrease recurrent preterm childbirths.(2)

The advisory panel of the Food and Drug Administration was charged with reviewing all the evidence and concluding whether there are any benefits of Makena in reducing premature childbirth and also whether the benefits of the medicine outweigh any risks.

What Made FDA Withdraw Approval of Makena and its Generics?

The FDA has pulled approval for Makena which was the drug intended to prevent premature births. The results of studies conducted on Makena and its impact on preventing premature births were disappointing. Thus, in 2020, the Food and Drug Administration recommended withdrawing the drug.(3)

Makena and its generics are not found to be effective in reducing the risk of premature births in women with a singleton pregnancy, who earlier had singleton spontaneous preterm childbirth, nor it was proven to be beneficial for women who are at high risk of premature birth. Moreover, there are also some known risks and side effects associated with the use of Makena.

Thus, the FDA withdrew its approval, and Makena and its generics are now considered unapproved products that cannot be lawfully distributed in interstate commerce.

Warnings to Note Down While Using Makena

If you are using Makena or you have been prescribed the drug by your doctor, you should be careful enough since it can cause specific side effects. Do not use the drug if you have diabetes, uncontrolled high blood pressure, unusual vaginal bleeding, jaundice, liver disease or liver cancer, or if you ever have had circulation issues, a stroke, or cancer of the breast, vagina, or uterus.

If you experience sudden numbness or weakness, jaundice, swelling in your hands or feet, problems with speech or vision, confusion, or symptoms of depression, after taking the injection of Makena, you should see your doctor immediately. You should know that many drugs might interact with Makena. Thus, your doctor should know about all medications that you are using.

Moreover, don’t forget to regularly visit your doctor so they can monitor your progress while you are using Makena.

Final Thoughts

Makena might be used for preventing premature births, however, right now it is extremely difficult to make a justified statement regarding its benefit, based on the current evidence. More research in this field is essential to understand this conflicting data in a better manner.


Team PainAssist
Team PainAssist
Written, Edited or Reviewed By: Team PainAssist, Pain Assist Inc. This article does not provide medical advice. See disclaimer
Last Modified On:July 31, 2023

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