According to the FDA, category C can mean 2 different things.
It can meant that animal studies showed harm to a fetus, but no human studies have been conducted.
From http://www.accessdata.fda.gov/script....cfm?fr=201.57
BUT, if no studies have been conducted at all... this would also be category C.
IMO, the FDA should have a seperate category for "no studies done" instead of lumping it into C. But they don't.
A drug that is category C because they just don't know could be as safe as an A... on the other hand, it could be as harmful as an X
It can meant that animal studies showed harm to a fetus, but no human studies have been conducted.
From http://www.accessdata.fda.gov/script....cfm?fr=201.57
Quote:
| If animal reproduction studies have shown an adverse effect on the fetus, if there are no adequate and well-controlled studies in humans, and if the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks, the labeling must state: "Pregnancy Category C. (Name of drug ) has been shown to be teratogenic (or to have an embryocidal effect or other adverse effect) in (name(s) of species ) when given in doses (x) times the human dose. There are no adequate and well-controlled studies in pregnant women. (Name of drug ) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." |
Quote:
| If there are no animal reproduction studies and no adequate and well-controlled studies in humans, the labeling must state: "Pregnancy Category C. Animal reproduction studies have not been conducted with (name of drug ). It is also not known whether (name of drug ) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. (Name of drug ) should be given to a pregnant woman only if clearly needed." |
A drug that is category C because they just don't know could be as safe as an A... on the other hand, it could be as harmful as an X
