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Introduction to Drugs and Pregnancy
Published in “Bert” Bertis Britt Little, Drugs and Pregnancy, 2022
Known human teratogens were identified through careful interpretation of data from case reports, clinical series, and epidemiologic studies. A recurrent pattern of anomalies in babies who sustained similar well-defined exposures at similar points during embryogenesis is suggestive that the agent in question may be teratogenic. Case reports are important in raising causal hypotheses. However, most hypotheses from case reports are subsequently proven incorrect. For example, a high incidence of environmental exposure to spermicides by pregnant women and congenital anomalies in offspring is a coincidental occurrence, despite what the legal outcome was. The law and case decisions are not a true reflection of truth, but usually the confluence of political and economic concerns used to beguile a jury. Dr. Robert Brent remarked after a huge failure in judgment found incorrectly found that spermicides caused birth defects that such substances were litogens, substances that cause lawsuits, not birth defects. For the record, nonoxynols in spermicides are NOT associated with an increased risk of birth defects.
Genetics
Published in Karl H. Pang, Nadir I. Osman, James W.F. Catto, Christopher R. Chapple, Basic Urological Sciences, 2021
Risk factors:Maternal age.Teratogens (e.g., tobacco smoking, alcohol, medical/recreational drugs, radiation).
Preconceptual Health
Published in Michelle Tollefson, Nancy Eriksen, Neha Pathak, Improving Women's Health Across the Lifespan, 2021
Nancy L. Eriksen, Kristi R. VanWinden, John McHugh
Teratogens may cause a spectrum of APOs, including fetal loss, major or minor fetal structural defects, impaired growth, preterm birth, or altered neurologic development. Many recognized teratogens are pharmaceutical agents, but they can also come in the form of recreational substances, maternal illness, infections, or environmental exposures. The effect of a teratogen on a given fetus is strongly influenced by the type, dose, route, and timing of the exposure; genetic factors; and concurrent exposures or environmental influences.
Comparative analysis of the use and control of thalidomide in Brazil and different countries: is it possible to say there is safety?
Published in Expert Opinion on Drug Safety, 2022
Soraya Machado de Jesus, Rafael Santos Santana, Silvana Nair Leite
Due to the benefits resulting from anti-inflammatory, immunomodulatory, and antiangiogenic properties the thalidomide has been tested in several clinical trials with promising results. It is mainly used in dermatological, chronic-degenerative conditions, related to HIV-AIDS and in oncological diseases [1,4,13]. Quickly this drug returned to use in some countries under restricted conditions of use. Since the disaster occurred, governments have instituted stricter regulations for drug approval, ensuring that safety and efficacy standards are met [1,3,4,13–15]. Such regulations have evolved into tools for monitoring birth defects, product labeling, pharmacovigilance, clinical guidelines. Furthermore, the countries also developed control monitoring to minimize the risks of exposure to teratogenic effects. However, there is a concern that emerges from the recent studies on the use of thalidomide for the treatment of COVID-19. Aside from the obvious historical facts surrounding the control of use, the clinical results are limited and questionable [16].
Ixekizumab: an IL-17A inhibitor for the treatment of axial Spondylarthritis
Published in Expert Review of Clinical Immunology, 2021
Stephanie R Harrison, Helena Marzo-Ortega
Ixekizumab has been studied in the over 65s and children aged 6–18 years in human studies which suggest the drug can be safely administered at age-appropriate doses with no significant differences in drug clearance. Studies in cynomolgus monkey revealed no demonstrable impact of reproductive organs, menstrual cycle length or sperm count though fertility was not evaluated specifically, nor pregnancy or lactation. The manufacturer therefore advises that females should be using reliable contraception whilst on treatment, avoid taking ixekizumab pregnancy and lactation and allow a minimum 10 week washout period between last drug dose and conception [79,81]. No specific advice is given with regards to discontinuing treatment in male patients attempting to conceive with their partner. Finally, no specific case reports of teratogenic effects have yet been published in patients who have conceived without interruption of treatment [79].
Genotoxic and mutagenic studies of teratogens in developing rat and mouse
Published in Drug and Chemical Toxicology, 2019
Eyyüp Rencüzoğulları, Muhsin Aydın
Teratogens are defined as agents that cause congenital defects. The effects of these agents depend on the time of exposure of the pregnant women, the dose of the medicine, the duration of the drug exposure, and the genetic susceptibility of the person. In Environment and Birth Defects book, which was published by James G. Wilson in 1973, it was stated that chemicals kill the embryo when taken in the early embryonic period and causes structural abnormalities in the embryogenesis period (Wilson, 1973). In the same book, Wilson stated that all mutagens could not be teratogenic, but the mechanisms of teratogenesis was listed as follows: (a) mutation, (b) chromosomal breaks or nondisjunction, (c) miotic interference, (d) altered nucleic acid integrity or function, (e) lack of precursors, (f) altered energy sources, (g) enzyme inhibition, (h) fluid-osmolyte imbalance, and (i) changed membrane characteristics. This suggests that genotoxic and mutagenic agents may also be teratogenic (el-Ashmawy et al. 2011, Shreder et al. 2011, Murkunde et al. 2012, El-Shershaby et al. 2014, Carvalho et al. 2016). Similarly, Wedebye et al. (2015) reported that the germline mutations were reproductive toxic.