Washington, D.C.—The following is a statement from the American College of Obstetricians and Gynecologists (ACOG):
“ACOG is aware of the decision by the manufacturer of Makena to voluntarily withdraw the product—currently the only FDA-approved medication to help prevent recurrent spontaneous preterm birth—from the market in the coming months. ACOG is still uncertain as to whether that timeline will be implemented as we await a potential final decision by the FDA. Until further information is available, ACOG’s current guidance, ‘Prediction and Prevention of Spontaneous Preterm Birth,’ will remain in effect.
“ACOG understands that its members who provide care to patients with prior preterm birth will soon lose access to a treatment option that was previously available to them. It is critical that other effective interventions be identified to prevent recurrent preterm birth for the health and well-being of our patients and their families.”