FDA Denies Petition to Withdraw Approval for Makena

The FDA denied a petition seeking the withdrawal of the AMAG Pharmaceuticals hormone drug Makena (hydroxyprogesterone caproate), which a patients’ rights group argues has possible links to developmental abnormalities.

The Escher Fund for Autism, a group representing individuals with autism and their families, argued Makena — the only drug product containing 17-alpha hydroxyprogesterone caproate (17-HPC) approved for use in pregnancy — was inappropriately approved by the agency.

The group claimed fetuses are susceptible to the medication and cited 17-HPC’s “hormone signal-disrupting properties.”