Pregnancy Class C: Acthar has been shown to have an embryocidal
effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
However, the drug is teratogenic and embryocidal
in animals at low doses, and mutagenic in some assays.
C: Either animal studies have revealed adverse effects on the fetus (teratogenic or embryocidal
or other) and there are no controlled studies in women, or studies in women and animals are not available.
Labeled as pregnancy category X because of significant teratogenic and/or embryocidal
effects of Rebetol in animal species.
The following may be associated with Acthar: increased susceptibility to infections, hypothalamic-pituitary-axis suppression and adrenal insufficiency, Cushing's Syndrome, elevated blood pressure, salt and water retention and hypokalemia, masking of symptoms of other disorders, gastrointestinal perforation and bleeding, behavioral and mood disturbances, worsening of comorbid diseases, ophthalmic effects, immunogenicity potential, negative effects on growth and physical development, decrease in bone density and embryocidal
The drugs previously were classified as category C, meaning that a drug had been shown to be teratogenic or to have embryocidal
effects in animals, but that there are no human data.
It is not teratogenic in rats and rabbits, but is embryocidal
The combination agent imipenem-cilastatin (Primaxin), rated C, is not teratogenic in animals but was embryocidal
and lethal in pregnant monkeys at about three times the recommended human dose.
Nalidixic acid is still used to treat urinary tract infections but not widely It is teratogenic and embryocidal
in rats when given at about six times the human dose.