Drug withdrawal notice for Makena (hydroxyprogesterone caproate injection)

A physician holds a vial of pills while taking notes at a computer.

To assist you in the care of your patients, we would like to alert you to the market withdrawal of Makena and hydroxyprogesterone caproate injection generics on April 6, 2023.1 We recommend you review your medical records and contact all patients for whom you have prescribed this medication to warn them of the market withdrawal.

Makena and its generics were initially approved to reduce risks of preterm birth in women pregnant with 1 baby who have a spontaneous preterm birth history. The U.S. Food and Drug Administration (FDA) had approved Makena and its generics under the accelerated approval pathway.

As a result of this withdrawal of approval, Makena and its generics are now unapproved products and cannot be lawfully distributed in interstate commerce. Approvals of the medications have been withdrawn because Makena and its generics are no longer shown to be effective, and the FDA believes the benefits do not outweigh the risks for the indication for which they were approved.2

Medications included in this withdrawal
Visit the FDA website for more details on the market withdrawal of Makena and its generics.

Information for providers:1,2

  • We have sent a letter to your Humana-covered patients who have had a claim for brand-name or generic Makena and asked them to contact their physicians or healthcare providers if they have experienced problems that may be related to using these drug products. Healthcare professionals should re-evaluate and discuss the treatment plan with their patients.
  • The FDA acknowledges some healthcare providers might continue to prescribe or administer their limited remaining supply to their patients. However, the FDA recommends prescribers consider its conclusion that these drug products are not shown to be effective for the indication for which they were approved and do not have benefits that outweigh their risks to patients.
  • Patients may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting Program online, by regular mail or by fax.
    • Online: Complete and submit the report.
      • Select “Consumer/Patient (FDA Form 3500B).”
    • Regular mail or fax: Download the form, PDF.
      • Complete and submit “Consumer Voluntary Reporting (Form FDA 3500B)” by mail to the address on the form or by fax to 800-FDA-0178 (332-0178).

References:

  1. “FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena,” U.S. Food and Drug Administration, last accessed April 12, 2023, www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena.
  2. “Makena (hydroxyprogesterone caproate injection) Information,” U.S. Food and Drug Administration, last accessed April 12, 2023, www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information.