On April 6, 2023, the U.S. Food and Drug Administration (FDA) formally rescinded its approval for Makena® (hydroxyprogesterone caproate) injection and its generic equivalents. It was the only drug indicated to prevent subsequent preterm deliveries for women who were pregnant with one child and who previously had given birth at less than 37 weeks of gestation. After Makena was given Accelerated Approval in 2011, its manufacturer was required to conduct ongoing clinical trials to prove its value. However, it has not been shown to be effective and its possible harm to the mother makes it unsafe to use. Potential risks to the mother include blood clots, reduced glucose tolerance, fluid retention, and depression. Additionally, no evidence from clinical trials shows that hydroxyprogesterone caproate provides any advantage for babies whose mothers used it while pregnant. Shipping between states is no longer legal. The FDA is preparing guidance on how existing supplies of hydroxyprogesterone caproate will be handled and whether pharmacies will be allowed to compound and dispense products containing it for the purpose of delaying birth. Those decisions and more information will be posted here.
At a Glance
- Brand (Generic) Name: Makena(hydroxyprogesterone caproate) and generics
- Manufacturer: Covis Pharma and others
- Date Withdrawn: April 6, 2023
- Indication: to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth
- In the U.S., the Centers for Disease Control and Prevention (CDC) estimate that about 10% of babies are born before their mothers have been pregnant for at least 37 weeks. Internal organs, including the brain, liver, and lungs do not develop fully until about 39 weeks.
- Approximately 16% of babies who die before they are one year old were born prematurely. They also are more likely than full-term babies (delivered at about 40 weeks) to have issues with breathing, eating, hearing, and seeing.
- Although any pregnancy can result in an early delivery, some factors raise the odds. African-American mothers have 1.5 times the risk compared to women in other ethnic groups. Preterm birth is more likely for women in their teens and for women over the age of 35. Those who smoke, drink alcohol, or misuse drugs also are at higher risk.