FDA Wants to Withdraw Pregnancy Drug, Makena

The Food and Drug Administration plans to pull the pregnancy drug Makena, given to reduce the risk of preterm birth, from the market, citing that it does not work. Physicians are divided on the issue and confused about whether to continue administering the drug. Andrew Combs, M.D., senior adviser for maternal-fetal medicine clinical quality for Pediatrix® Medical Group, said the group’s national network of physicians use it only “occasionally for extremely high-risk patients whose prior preterm birth was at a very early gestational age, or for patients who received Makena in a previous pregnancy and had a good outcome.” “But by and large, usage has greatly fallen off,” added Dr. Combs.

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