March 16, 2015
Re: Citizen Petition to Withdraw Approval for 17α-Hydroxyprogesterone Caproate (“17-OHPC,” Including Brand “Makena”) as a Drug Used in Pregnancy, Pending Fetal Germline Impact Assessment
To the Commissioner of the Food and Drug Administration:
The undersigned (or “Petitioner”) respectfully submits this petition in accordance with 21 C.F.R. 10.30 to request that the Commissioner of Food and Drugs withdraw approval for the drug 17-alpha hydroxyprogesterone caproate (“17-OHPC,” including brand “Makena”) as a drug used in pregnancy, pending assessment of potential deleterious impacts to the fetal germline.
The undersigned was prenatally exposed to this drug in 1965, believes she has suffered injury as a result, and has located numerous similarly exposed individuals suffering similar unforeseen and grievous injury. The injuries are consistent with research demonstrating adverse epigenetic effects (“epimutation”) of hormone signal-disrupting compounds on the delicate process of fetal germline synthesis, with temporal associations between the introduction of the drug and the unexpected deleterious effects, and with mounting evidence that autism and related neurodevelopmental abnormalities are at least in part caused by de novo perturbations of the germline.
The FDA may hesitate to re-evaluate a drug so long and so pervasively used. However, 17-OHPC was initially approved at a time before fetal germline vulnerability came to be broadly appreciated in biology and toxicology, and before generational effects of synthetic hormone signal disruption1 came to be appreciated. As when the thalidomide tragedy belatedly shattered the false belief in placental impermeability and shone a light on the particularly horrific nature of derangements occurring during critical developmental windows, and as when the diethylstilbestrol (DES) catastrophe upended conventional wisdom by revealing time-delayed or invisible effects of prenatal exposure, we now face a third wave of most unfortunate revelation: that pregnancy medications can, however inadvertently, “drug the DNA” of grandoffspring, a biological phenomenon that, once again, requires an urgent response by regulators....
Please read the entire Petition (PDF) here.