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Introduction
Published in Radhwan Nidal Al-Zidan, Drugs in Pregnancy, 2020
Humans have a long history of using different chemicals and herbs in treating a variety of medical conditions in both genders. The use of such compounds for pregnant women was not an exception. There is a translated Assyrian Script, dating back 3500 years, which describes three different prescriptions to relieve abdominal cramps in pregnant women [1]. However, the concern about the safety of chemical agents (drugs and herbs) given to females during pregnancy was not raised until the tragedy of the thalidomide. In 1957, thalidomide gained marketing approval as a safe over-the-counter (OTC) drug for treating insomnia in pregnant women. Unfortunately, a few years later case reports of phocomelia (malformation of the limbs) began to accumulate. With thousands of children born with tragic limb deformities, the health care providers and the public around the world were shocked by the unforeseen relationship of thalidomide use in pregnant women and the development of serious birth defects in the newborns.
Methodological Issues In Epidemiologic Studies Of Drug Effects
Published in Michele Kiely, Reproductive and Perinatal Epidemiology, 2019
Less than 2 months later, another letter appeared: During the year 1961 — and in fact within a few months — we have encountered in this hospital four infants affected by phocomelia...In 1961 there was no increase in the observed general rate of severe malformations, and we were puzzled by this sudden increase in frequency of what must be a very rare abnormality. Not a single phocomelic infant was born here in the decade 1951—1960, during which period well over 20,000 confinements took place; nor is there any record of an earlier case...26
Reproductive and Developmental Toxicity
Published in Frank A. Barile, Barile’s Clinical Toxicology, 2019
Anirudh J. Chintalapati, A. Barile Frank
The thalidomide disaster of 1961 initiated a significant effort to establish a program for teratogenicity testing. Developed as a sedative/hypnotic with no particular advantage over drugs of the same class, thalidomide was initially shown to lack teratogenic effects in all species tested except rabbits. Soon after its introduction to the European market, the drug was linked to the development of a relatively rare birth defect known as phocomelia. The epidemic proportions of the teratogenic effect of thalidomide prompted the passage of the Harris–Kefauver Amendment in 1962, one of many additions since to the Federal Pure Food and Drug Act. The Amendment requires extensive pharmacological and toxicological preclinical research before a therapeutic compound can be marketed.*
Etonogestrel-releasing contraceptive implant in a patient using thalidomide for the treatment of erythema nodosum leprosum: a case report
Published in Gynecological Endocrinology, 2022
Edson Santos Ferreira-Filho, Luis Bahamondes, Daniele Coelho Duarte, Ana Lúcia Monteiro Guimarães, Patrícia Gonçalves de Almeida, José Maria Soares-Júnior, Edmund Chada Baracat, Isabel Cristina Esposito Sorpreso
The use of thalidomide by women of reproductive age had neonatal and perinatal repercussions and caused severe congenital defects in more than 10,000 children between 1957 and 1962. Impairment was primarily seen in the limbs, face, eyes, ears, genital organs, heart, kidneys, gastrointestinal tract, and spine. Phocomelia remains the most striking deformity brought on by thalidomide as well as the stereotyped image of thalidomide embryopathy. Thalidomide use is carefully monitored through successful strategies for supervising patients to ensure they do not get pregnant during treatment [5]. The Brazilian Ministry of Health states that a thalidomide-based medication may only be prescribed for women of reproductive age after medical evaluation has ruled out pregnancy by a sensitive method and through proof of use of at least 2 (two) effective contraceptive methods for women using thalidomide [6]. However, to the best of our knowledge, there are no studies showing an absence of drug interaction between thalidomide and hormonal contraception.
Phantom Phenomena—An Introduction to “Phantom Penis: Extrapolating Neuroscience and Employing Imagination for Trans Male Sexual Embodiment”
Published in Studies in Gender and Sexuality, 2020
Paul D. McGeoch, V. S. Ramachandran
As almost everyone with xenomelia dates their desire for an amputation to their childhood, this suggests that despite a lifetime of living with the offending limb, it fails to fully incorporate into their body image. We were able to demonstrate the converse of this observation in a 57-year-old woman (RN) with right upper limb phocomelia (McGeoch and Ramachandran, 2012). RN was born with a severely foreshortened right arm and a markedly deformed right hand. In her case it was due to chance and not in utero exposure to thalidomide. She only had the rudiment of a thumb, no index finger, and the middle and ring fingers were shorter than on the left hand and fixed in flexion. Only her right little finger was functional. Unfortunately, at the age of 18 years she was involved in a car crash and her right upper limb was crushed. Her orthopedic surgeons struggled to get it to heal for six months, but eventually it had to be amputated.
A review of translational medicine. The future paradigm: how can we connect the orthopedic dots better?
Published in Current Medical Research and Opinion, 2018
Mohamed Mediouni, Daniel R. Schlatterer, Henning Madry, Magali Cucchiarini, Balwant Rai
From a historical perspective, much can be learned from several examples where the bench-side knowledge progressed too quickly to the bedside. The most glaring example was the use of thalidomide1,2,3. Developed in West Germany in 1957, it was effective in treating pregnant women experiencing morning sickness. What was not known at the time was that thalidomide use could also cause severe birth defects such as phocomelia and amelia4,5. As thousands of cases were reported its use was abruptly discontinued and more stringent rules were written regarding medication development and clinical application. This is an example of two-way bedside to bench-side communication and collaboration ultimately resulting in the development of much safer morning sickness and anti-anxiety medications.