I. Psychotropic drug safety levels.
The FDA classifies drugs into five classes based on the magnitude of their effect on fetal safety.
1, pregnancy class A: there are sufficient numbers of well-controlled human studies, showing that the drug in early pregnancy for the fetus no adverse effects (no such signs in late pregnancy).
2. Pregnancy level B: Animal studies have failed to show that the drug has adverse effects on the embryo, but there is a lack of sufficient number of well-controlled human studies to confirm this; or Animal studies have shown that the drug may have adverse effects on the embryo, but there are sufficient number of well-controlled human studies to show that the drug has no adverse effects on the fetus during pregnancy.
3, Pregnancy level C: Although animal experiments have shown that the drug may have adverse effects on the embryo, there are no sufficient number of well-controlled human studies to confirm; however, due to the need for treatment, even if there is such a potential, on balance, the drug should still be used for pregnant women.
4.Pregnancy D level: from the market survey or information feedback “adverse reaction” information, or from human studies, that the drug has the potential for fetal harm; but because of the need for treatment, even if there is such potential, the balance of convenience, the drug should still be used for pregnant women.
5. Pregnancy level X: It is proved from animal or human studies that the drug may cause embryonic malformation, and/or ‘adverse reaction’ information obtained from market survey or information feedback, or from human studies that the drug has the potential to cause harm to the fetus; even if it is necessary for treatment, it is clear that, on balance, the drug should not be used for pregnant women. The drug should not be used for pregnant women.
The relationship between psychotropic drugs and pregnancy and fetal safety.
1. Antipsychotics
Clozapine is pregnancy level B, the rest are pregnancy level C.
2. Anti- Depression
(1) Clomipramine, doxepin, citalopram, fluvoxamine, trazodone, mianserin, mirtazapine, fluoxetine, sertraline are all pregnancy grade C.
(2) nortriptyline, paroxetine as pregnancy level D (Note: Australian standard, classify paroxetine as pregnancy level C).
3.Anxiolytic and sleeping drugs
(1) Zolpidem (Synthroid) is pregnancy level B.
(2) benzodiazepines (Valium class I) such as alprazolam, eszopiclone, clonazepam, lorazepam, etc., are pregnancy level D.
4.Mind-stabilizing drugs
(1) Lamotrigine, which is pregnancy level C.
(2) Lithium carbonate, carbamazepine, sodium valproate, are pregnancy grade D.
5.Dementia treatment drugs
(1) Amritsyn, Esnon, all are pregnancy grade C. According to domestic and foreign expert opinions, it is generally relatively safe to take psychotropic drugs of pregnancy grade C and above (except paroxetine) while pregnant.