FDA Withdrawal of Makena®

Date: April 10, 2023

Attention: All Providers

Effective Date: April 06, 2023

Call to action: Effective April 6, 2023, the U.S. Food and Drug Administration (FDA) announced the final decision to withdraw the approval of Makena and its generics, which was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. Makena and its generics are no longer FDA approved and cannot be lawfully distributed. This is in result due to recent data showing that Makena is no longer effective and its benefits do not outweigh the risk for the indication for which they were previously approved.

How this impacts providers: Makena and its generic hydroxyprogesterone caproate will no longer be manufactured, and current available inventory will no longer be distributed.  Navitus has also removed Makena and its generics from the formulary. Navitus will not provide reimbursement for any Makena or hydroxyprogesterone caproate prescription(s) after the effective withdrawal date.

Next steps for providers: Prescribers should share this communication with their staff and patients who are currently on Makena or the generic versions of Makena. As a healthcare provider, we understand that this news may be concerning for your patients; we encourage you to proactively reach out to your patients to discuss alternative treatment options.  

Note: Please find FDA News Release at: www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena.

If you have any questions, please email TCHP Pharmacy at: tchppharmacy@texaschildrens.org.

For access to all provider alerts,log into:
www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers.