May 4, 2023
The FDA announced the decision to withdraw the approval of Makena and Hydroxyprogesterone caproate injections on April 6, 2023.
Makena and its generics are not shown to be effective for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. In addition, the drugs are not shown to improve the health of the babies born to this population.
Patients have been asked to speak to their physician on alternative healthcare treatment options.
For questions about this withdrawal, visit www.fda.gov/drugs.