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Chemotherapy in pregnancy
Published in Hung N. Winn, Frank A. Chervenak, Roberto Romero, Clinical Maternal-Fetal Medicine Online, 2021
Gemcitabine is indicated in the treatment of cancers of the ovary, pancreas, bladder, lung, and in sarcomas. There are little data regarding the intrapartum use of gemcitabine in the literature. Studies in mice have demonstrated teratogenicity including decreased fetal weight, cleft palette, and increased mortality (73). Kim et al. reported on a woman with non-small cell lung cancer, treated with palliative docetaxel, gemcitabine, and cisplatin from weeks 9 to 22 of an unrecognized pregnancy. A healthy infant was delivered at 33 weeks with no recognizable anomalies (38). Hematologic toxicity is commonly dose limiting and the compound should be used with caution toward the end of the third trimester. In the absence of more case reports, or perhaps a series of patients, other compounds might be considered prior to choosing gemcitabine during pregnancy.
Laboratory and Clinical Follow-Up
Published in Ayse Serap Karadag, Berna Aksoy, Lawrence Charles Parish, Retinoids in Dermatology, 2019
Nadide Burcu Öztürk, Berna Aksoy
Many risk management programs have been produced to prevent the teratogenic effects of isotretinoin and to control the use of the drug among women. The iPLEDGE program, initiated in 2006 by the FDA, is the most well known. Patients are informed of teratogenicity, and a written record is obtained. As a precaution, women of childbearing potential are required to use two complementary contraceptive methods, have a monthly pregnancy evaluation after starting treatment with isotretinoin, perform at least two pregnancy tests prior to beginning the drug and obtain two negative results, and to start the drug on the second or third day of the next menstrual period (3).
Animal Toxicity Studies
Published in Nicola Loprieno, Alternative Methodologies for the Safety Evaluation of Chemicals in the Cosmetic Industry, 2019
Teratogenicity studies allow the identification of those agents that induce structural malformations, metabolic or physiological dysfunctions, and behavioral alterations in the offspring, either at birth or in a defined postnatal period.
Managing women of childbearing age with chronic myeloid leukemia: safety and treatment considerations
Published in Expert Review of Hematology, 2023
HF Robertson, MJ Buckton, JF Apperley
Imatinib is the oldest and most widely used TKI in CML and accordingly, has the largest wealth of evidence regarding its use in pregnancy. Preclinical studies showed clear evidence of teratogenicity and fetal toxicity (Novartis investigator brochure). It was 6 years after its introduction in 2002 that it was clearly shown to be unsafe for use in the first trimester of pregnancy in humans. Pye et al. investigated 180 women exposed to imatinib at various stages of their pregnancy [9]. Information pertaining to TKI exposure in each trimester was available in 146 patients (103 patients were exposed in the first trimester, 18 received imatinib throughout pregnancy to term, 13 received imatinib until elective or spontaneous termination, 7 received imatinib throughout pregnancy but without available pregnancy outcomes, four patients were exposed after the first trimester and 1 received imatinib before last menstrual period). Of the 125 patients with full outcome data, 63 (50%) delivered normal healthy infants. Eighteen (14%) experienced spontaneous abortion which was reported as comparable to the rate in the normal population. However, 12 (9.6%) infants demonstrated congenital abnormalities. Importantly, three children demonstrated a similar, complex constellation of defects, suggesting that the drug was largely responsible. Of the 12 with congenital malformations, 10 of these are known to have been exposed to imatinib within the first trimester (the remaining 2 did not have available information). Additional studies have provided similar findings (Table 2).
State of the art, new treatment strategies, and emerging drugs for non-hormonal treatment of endometriosis: a systematic review of randomized control trials
Published in Gynecological Endocrinology, 2022
Mislav Mikuš, Salvatore Giovanni Vitale, Mario Ćorić, Vendy Zajec, Michał Ciebiera, Jose Carugno, Maurizio Nicola D’alterio, Mislav Herman, Tomislav Puževski, Stefano Angioni
Following the blockade of angiogenesis in cancer treatment, antiangiogenic agents have been proposed that may be similarly effective in endometriosis, particularly in the early stages when neovascularization is a critical process for disease progression while maintaining the normal menstrual cycle. However, the acceptable safety profile for benign disease differs significantly from potentially life-threatening diseases such as cancer. The major obstacle in developing an antiangiogenic treatment is delineating the antiangiogenic effect on endometriotic lesions while maintaining the physiological angiogenesis necessary for reproduction. In addition, the risk of teratogenicity in case of pregnancy must be evaluated. Considering their mechanism of action, it seems unlikely that antiangiogenic drugs can affect endometriotic lesions in advanced disease stages due to the dominance of inflammation and fibrosis. On the contrary, these agents might play a role in the early and postoperative phases of endometriosis treatment [23].
Pneumocystis jirovecii: a review with a focus on prevention and treatment
Published in Expert Opinion on Pharmacotherapy, 2021
R. Benson Weyant, Dima Kabbani, Karen Doucette, Cecilia Lau, Carlos Cervera
Like in non-pregnant patients, there are alternative treatments available should TMP-SMX ineffective or intolerable. Despite crossing the placenta, dapsone is considered safe in pregnancy. Its use has been established for the treatment of malaria, leprosy, and various dermatological conditions. However, there is a small risk of fetal hemolysis, particularly in G6PD deficiency. Clindamycin has also been shown to cross the placenta, but animal studies have found no increased risk of birth defects when used in the 2nd or 3rd trimesters. Primaquine is generally not used in pregnancy as it carries a risk of hemolysis to both the mother and the fetus, and again the risk is increased in G6PD deficiency. Atovaquone’s post-marketing surveillance has not found any increased risk of birth defects associated with its use. Like dapsone, atovaquone is used with caution as possible fetal harm was demonstrated in animal studies. Lastly, pentamidine has been shown in animal studies to be embryotoxic when given at the 4 mg/kg/day dose. Teratogenicity, however, has not been found when used in rats and rabbits [129].