Table 1.
Candidate anti-ZIKV drugs and considerations for use in pregnancy.
| Drug name | Pregnancy categoryi |
Other considerations and notes |
|---|---|---|
| Auranofin | C | • Inform women of childbearing potential of the potential risk of therapy during pregnancy. |
| Azathioprine | D | •Contraindicated for use in pregnant women with Rheumatoid Arthritis |
| Bortezomib | D | • Women of reproductive potential should avoid becoming pregnant while on therapy. |
| Clofazimine | C | • Some animal studies have failed to reveal evidence of teratogenicity, but studies done at high doses have demonstrated fetotoxicity. There are no controlled data in human pregnancy. |
| Cyclosporine A | C | • Advise of the potential risks if used during pregnancy |
| Dactinomycin | D | |
| Daptomycin | B | |
| Deferasirox | C | |
| Digoxin | C | • Concentrations with anti-ZIKV activity may be toxic. |
| Fingolimod | C | • A pregnancy registry has been established to collect information about the effect of this drug during pregnancy. |
| Gemcitabine·HCl | D | |
| Ivermectin | C | |
| Mebendazole | C | • Inform of potential risk to fetus if taken during pregnancy, especially during first trimester. |
| Mefloquine·HCl | B | |
| Mercaptopurine Hydrate |
D | |
| Methoxsalen | C | • Usually given in combination with ultraviolet (UV) radiation therapy. |
| Micafungin | C | |
| Mycophenolate Mofetil | D | • Boxed warning: Use during pregnancy is associated w/ increased risks of 1st trimester pregnancy loss and congenital malformations; counsel females of reproductive potential regarding pregnancy prevention and planning. |
| Mycophenolic Acid | D | • Boxed warning: Use during pregnancy is associated w/ increased risks of pregnancy loss and congenital malformations; counsel females of reproductive potential regarding pregnancy prevention and planning. |
| Palonosetron·HCl | B | • Drug interaction with SSRIs (Sertraline) causing serotonin syndrome |
| Pyrimethamine | C | • Women of reproductive potential should avoid becoming pregnant while on therapy. |
| Sertraline·HCl | C | • Boxed warning: Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. • Consider tapering dose during third trimester of pregnancy. |
| Sorafenib Tosylate | D | • Inform that the drug may cause birth defects or fetal loss during pregnancy; instruct both males and females to use effective birth control during treatment and for at least 2 weeks after stopping therapy. Instruct to notify physician if patient becomes pregnant while on therapy. |
| Thioguanine | D | • May cause fetal harm. |
FDA Pregnancy Categories are defined as follows (modified from www.drugs.com):
Category A: Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
It should be noted from that effective 30 June 2015 the FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, “Pregnancy and Lactation Labeling Rule” (PLLR or final rule). The PLLR removes pregnancy letter categories from drug labels, however, these, categories remain useful as general guidelines for clinicians and investigators.