FDA panel says preterm birth drug should be withdrawn

Volume 400, Issue 10362

29 October 2022 

WORLD REPORT  Makena has been given to hundreds of thousands of patients over the past 11 years. Susan Jaffe reports from Washington, DC.  

The only treatment in the USA to prevent premature births is ineffective and should be withdrawn from the market, according to the Food and Drug Administration’s (FDA) Obstetrics, Reproductive and Urologic Drug Advisory Committee. The recommendation has renewed scrutiny of a special drug approval process that raises patients’ hopes by allowing them to take medications that have not been fully tested for efficacy and safety [Continued here.]