Doctor speaking to woman during medical appointment

Makena® Pulled Off the Market

Makena® , the injection used to reduce the risk of recurrent preterm delivery, has been pulled off the market by the U.S. Food and Drug Administration (FDA). The injection was given weekly to lessen the chance of preterm birth in women who had already experienced a spontaneous preterm birth.

Makena® can no longer be obtained from pharmacies including home health companies. But the medication itself is safe to use if you have it already or if your home health provider has a supply on hand. And there is no cause for concern if you have already been receiving injections. The reason it was removed from the market was that the FDA felt the makers of the medication did not prove it worked well enough to keep it on the market. Preterm babies can have serious problems related to being born early, and initial testing showed the drug did work.

“We have seen many patients benefit from the use of Makena® ,” says Dr. Cathy Larrimore, who is disappointed in the decision. “Patients who delivered early in the past, then used Makena® during a second pregnancy and delivered at full term are likely to be upset that they can no longer use this medication.”

Vaginal progesterone, which is recommended to treat a short cervix during pregnancy, may be offered to some patients who have a short cervix or who do not feel comfortable going without any treatment at all to help prevent spontaneous preterm birth.

“Although the vaginal progesterone is available, it is not approved by the FDA to prevent recurrent preterm birth unless the cervix is found to be shortened,” Dr. Larrimore says. “But it is a progesterone and has not been shown to be harmful. Each patient will have to discuss medication use with her own physician.”

Your health during pregnancy and preventing preterm delivery when we can are important, which is why Covington Women’s Health Specialists is here to support you. To discuss your concerns during pregnancy with a member of our caring team, make an appointment online or call us at 770-385-8954.