The FDA has issued a Questions and Answers document to clarify its June 15, 2012 statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena; Ther-Rx Corporation) for the reduction of preterm birth risk.

The FDA’s Questions and Answers document recommends that healthcare providers prescribe FDA-approved Makena first-line for clinically indicated patients and provides guidance on how patients can know if they are receiving Makena. In addition, the FDA recommends the use of Makena rather than compounded drug formulations of hydroxyprogesterone caproate in pregnant women at high risk for recurrent preterm birth. At this time, some women at high risk, covered under Medicaid, may not be eligible to receive coverage for Makena as first-line treatment. During this period, K-V has reduced the pricing of Makena for both commercial and Medicaid payers.

The agency also describes its enforcement policy towards compounded formulations of hydroxyprogesterone caproate.  The FDA reiterated that it does not consider compounding large volumes of copies of any approved commercially-available drug to fall within the scope of traditional pharmacy practice. Further, the FDA may take enforcement action against pharmacies that essentially copy commercially available products “for which there does not appear to be a medical need for individual patients to whom the drug is dispensed.”

Makena, a progestin, is the only FDA-approved medication indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. 

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Do you agree with the FDA’s recommendations that Makena should be prescribed as first-line therapy for women at high risk for preterm birth?