In 2020, the Food and Drug Administration approved 53 new drugs for humans. One of these agents, Annovera (segesterone and ethinyl estradiol), is a vaginal ring to prevent pregnancy and is not relevant in this article. A second drug, Asparlas (calaspargase pegol), indicated to treat acute lymphoblastic leukemia, has not yet been released by its manufacturer. Orgovyx (relugolix) is used for prostate cancer and Lampit (nifurtimox) is drug used in children – neither of these two agents will be covered. The remaining 49 are covered below. The agents with molecular weights less than 1,000 probably cross the placenta in the first half of pregnancy, but nearly all, regardless of MW, will cross in the second half of pregnancy.
Gerald G. Briggs
No human pregnancy data for these agents has been found, but there are five drugs included in pregnancy registries. It will take some time before the outcomes of these drugs are published. The routine absence of pregnancy data for most drugs was pointed out in an article that I coauthored, “Should pregnant women be included in phase 4 clinical drug trials?”. The article makes a strong argument for including some pregnant women in these trials.
Anti-infectives
Artesunate (384)
The drug appears low risk when used in the second and third trimesters. There is inadequate information regarding its use in the first trimester, so the safest course for the embryo appears to be avoiding its use during this period. A single intravenous dose given to rats early in gestation resulted in embryolethality.
Ebanga (ansuvimab) (147,000)
Studies on its use in pregnant animals have not been conducted.
Inmazeb (atoltivimab, maftivimab, odesivimab) (144,000-146,000)
Inmazeb is a combination of the three agents. Studies on its use in pregnant animals have not been conducted.
Veklury (remdesivir) (603)
Veklury is indicated for the treatment of pregnant women hospitalized with COVID-19 who are at risk for serious morbidity and mortality. The drug should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
Antineoplastics
Ayvakit (avapritinib) (499)
The drug may cause fetal harm. The drug was teratogenic in animals.
Blenrep (belantamab mafodotin-blmf) (152,000)
A B-cell maturation antigen, it is indicated for the treatment of multiple myeloma. No human or animal pregnancy data have been located.
Danyelza (naxitamab-gqgk) (144,000)
This agent is used for the treatment of neuroblastoma. Based on its mechanism of action it may cause fetal harm if used in pregnancy.
Gavreto (pralsetinib) (534)
Gavreto is indicated for the treatment of small cell lung cancer. It may cause embryo-fetal harm if used in pregnancy.
Inqovi (cedazuridine + decitabine) (268,228)
The drug combination can cause fetal harm in human pregnancy. It is toxic in pregnant animals.
Margenza (margetuximab-cmkb) (149,000)
Although there are no data on the use of this drug in human pregnancy, the findings in animals and mechanism of action suggest that it will cause fetal harm.
Monjuvi (tafasitamab-cxix) (150,000)
This drug is a cytolytic antibody that is indicated in combination with lenalidomide. The combination may cause fetal harm.
Pemazyre (pemigatinib) (488)
It is indicated for the treatment of cholangiocarcinoma. In an animal study, the drug caused fetal defects, fetal growth retardation, and embryo-fetal death at maternal exposures lower than the human exposure.
Qinlock (ripretinib) (510)
This drug is used for the treatment of patients with advanced gastrointestinal stromal tumor. The drug was teratogenic in pregnant animals.
Retevmo (selpercatinib) (526)
This is a kinase inhibitor used for the treatment of small cell lung cancer. The drug is teratogenic in animals.
Sarclisa (isatuximab-irfc) (148,000)This drug is used in combination with pomalidomide and dexamethasone. The combination would probably cause major toxicity in an embryo or fetus.
Tabrecta (capmatinib) (412 – free base)Capmatinib is a kinase inhibitor used for the treatment of metastatic non–small cell lung cancer. It is teratogenic in animals.
Tazverik (tazemetostat) (654)Tazemetostat is indicated for the treatment of epithelioid sarcoma and follicular lymphoma, The drug is teratogenic in animals.
Trodelvy (sacituzumab govitecan-hziy) (1,602)This agent is used for the treatment of breast cancer. The drug has not been tested in pregnant animals. However, according to the manufacturer, there is a high possibility of human teratogenicity if it is given to a pregnant woman.
Tukysa (tucatinib) (481)
Tukysa is a tyrosine kinase inhibitor that is used in combination with trastuzumab and capecitabine for the treatment of breast cancer. The drug is teratogenic in animals.
Zeposia (ozanimod) (441)
Zeposia is indicated for the treatment of multiple sclerosis. The drug takes about 3 months to eliminate from the body. The drug is teratogenic in animals.
Zepzelca (lurbinectedin) (785)
This agent is used for the treatment of metastatic small cell lung cancer. The drug is teratogenic in animals.
Antiemetics
Barhemsys (amisulpride) (369)
This agent is Indicated to prevent nausea and vomiting. Animal data suggest low risk of embryo/fetal birth defects.
Antimigraine
Nurtec (rimegepant) (611)
Nurtec is indicated for acute treatment of migraine. Development toxicity was not observed in animals given doses similar to those used in humans.
Vyepti (eptinezumab-jjmr) (143,000)
A humanized monoclonal antibody that is given every 3 months to prevent migraine. There was no embryo-fetal harm in animals given the drug.
CNS
Byfavo (remimazolam) (493 – free base)
This drug is indicated for procedural sedation in adults undergoing procedures lasting 30 minutes or less. No defects were observed in animals.
Diagnostics
Cerianna (fluoroestradiol F 18) (289)
It is indicated for use with PET for characterization of estrogen receptor status in patients with ER-positive breast cancer. It has the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. There are no data on its use in pregnant women or animals.
Detectnet (copper CU-64 dotatate) (1,497)
All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. There are no pregnancy data in humans or animals