Thalidomide congenital defects. The Lancet 2 (December 16, 1961): 1358.
Thalidomide congenital defects. Thus, clinicians must avoid using thalidomide in pregnant women or women who may become pregnant while taking the drug. Feb 22, 2025 · Introduction: The Thalidomide Disaster is one of the most infamous medical tragedies in history. I have seen 52 malformed infants whose mothers had taken ‘Contergan’ in early pregnancy, and I understand that Aug 6, 2018 · The letter, thought to be the first published suggestion from a doctor of teratogenicity of thalidomide in humans, was brief—only five sentences. 16) describes congenital abnormalities in babies delivered of women who have taken thalidomide. This may not be the complete list of references from this article. How a Commonly Used Drug Caused Birth Defects - Part One by Betty Mekdeci Executive Director Birth Defect Research for Children Environmental causes of birth defects have increasingly been recognized since the mid-20th century. Over half the cases involved absent or partially missing limbs. [PubMed] [Google Scholar] Kajii T. Similar Jan 1, 2022 · Thalidomide is responsible for the biggest medical disaster in history, causing severe birth defects in more than 10,000 children, globally, between 1957 and 1962. Jul 9, 2021 · The world witnessed the catastrophic consequences of the teratogenic drug thalidomide in the late 1950s and early 1960s. In recent months I have observed that the incidence of multiple severe abnormalities in babies delivered of women who were given the drug thalidomide (‘Distaval’) during pregnancy, as an anti-emetic or as a sedative, to be almost 20%. Fetal malformations due to thalidomide occur when the drug is ingested by a pregnant woman between days 35 and 49 after the last menstrual period. Sep 12, 2025 · Thalidomide, compound in medicine initially used as a sedative and an antiemetic until the discovery that it caused severe fetal malformations. Synonyms: congenital malformation caused by cytotoxic Oct 1, 2022 · Most historiographies of the crossroads of environmental and reproductive health in 20th century start and end with the case of thalidomide. History and description of the thalidomide drug, that caused a worldwide wave of birth defects cases in the 60s. Common Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women. Although true phocomelia in the May 8, 2018 · Abstract Thalidomide embryopathy results from the ingestion of thalidomide in the first trimester during pregnancy, causing multiple forms of congenital abnormalities of variable severity that involve all systems. However, its use is limited due to its potent teratogenic activity. There are four main types of congenital anomalies: malformations, disruptions, deformations, and dysplasias. Originally marketed as a sedative, thalidomide gained immense popularity worldwide among pregnant women because of its effective anti-emetic properties in Possible birth defects include phocomelia, dysmelia, amelia, bone hypoplasticity, and other congenital defects affecting the ear, heart, or internal organs. A classification and a pattern of malformation in a group of congenital defects of the limbs. G. Approximately 40% of affected Thalidomide is a sedative that was prescribed to pregnant women in the late 1950s and early 1960s to alleviate morning sickness, but it was later discovered to cause severe birth defects when taken during a critical period of fetal development. In fall 1961, Lenz, noting these congenital malformations in the German population, suggested a possible correla-tion with thalidomide taken during pregnancy. Dec 22, 2020 · The therapeutic was commonly prescribed as a treatment for morning sickness in pregnant women, ultimately leading to congenital deformities in thousands of newborns. It was withdrawn in late 1961 after causing severe birth differences in thousands of children around the world, including the UK, Europe, Japan, Australia and the US. It caused an increase in miscarriage and still birth rates and a 40% increase in infant mortality, and up to 10,000 children around the world were born with severe limb malformations, as well as other much less common congenital defects (1 – 7). We report a case of fetal amelia, ultrasound findings, The thalidomide tragedy of the 1960s resulted in thousands of children being born with severe limb reduction defects (LRD), among other malformations. Thalidomide is a teratogenic drug, meaning that when taken while pregnant, it can have terrible impacts on fetal development and cause irreversible damages. Aug 2, 2018 · It's been nearly six decades since suspicions first arose that a common anti-nausea drug named thalidomide was responsible for shocking deformities in infants. Indeed, many of the present beneficiaries of the Trust have been accepted on the basis of clinical judgements, without direct evidence of thalidomide exposure. [2] Occurrence in an individual results in various abnormalities to the face, limbs, ears Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women. The tragedy now serves as an infamous reminder of the importance of clinical testing and strict drug regulation. But what is thalidomide, and what exactly did Dr Congenital dysmelia can also affect all the limbs and can present as very similar to thalidomide impairments. , Kida M. Thalidomide and Congenital Abnormalities Letter By: W. [1][2] A prominent cause of phocomelia is the mother being prescribed the use of the drug thalidomide during pregnancy; however, the causes of most cases are to be determined. Fetal exposure to thalidomide occurred primarily from 1957 to 1961, when it was used as a treatment for A teratogen that can cause intercalary limb deficiencies is thalidomide. When taken during the first trimester of pregnancy, thalidomide prevented the proper growth of the fetus resulting in horrific birth defects ("thalidomide embryopathy") in thousands of children around the world. Feb 20, 2020 · In addition to easily recognizable limb anomalies, other effects attributed to thalidomide use include congenital heart disease, malformations of the inner and outer ear, and ocular abnormalities. Among clinicians and researchers who have contributed … Perhaps no other drug in modern medicine rivals the dramatic revitalization of thalidomide. There are several types of birth defects, with causes that range from genetic changes to environmental factors. By 1962 Genetic syndromes caused by pathogenic variants of the SALL4 gene phenocopy thalidomide embryopathy with congenital malformations ranging from phocomelia, reduced radial ray, to defects of the heart, kidneys, ear, eye, and possibly cerebral midline and pituitary. Nevertheless, the nature and pattern of the defects are, in most cases, characteristic enough to be recognizable to an experienced eye. Letters to the Editor Volume 279, Issue 7219 p45-46 January 06, 1962 May 28, 2025 · A newly published review in Birth Defects Research helps unlock the 65-year-old puzzle of devastating limb malformations associated with thalidomide exposure. Though the use of thalidomide was banned in most countries at that time, thalidomide proved to be a useful treatment for leprosy and later, multiple myeloma. Henkel L. Thalidomide ingestion was known to have occurred in 9 cases, but may well have been causative in a larger The reports of congenital malformation kept coming in. Mar 15, 2010 · How thalidomide deforms limbs has continued to baffle scientists. The thalidomide molecule occurs naturally in two forms, (R)- thalidomide and (S)- thalidomide, which are enantiomers, or mirror image molecules, of each other. Dec 15, 2010 · The classic thalidomide embryopathy (sometimes known as fetal thalidomide syndrome) shows a pattern of major malformations, variably consisting of phocomelia or amelia, anotia and other ear abnormalities, congenital heart defects, duodenal atresia, aplasia of thumbs, and triphalangism. Neural Tube Defects: Valproic acid exposure during pregnancy can cause neural tube defects, including spina bifida and anencephaly. Apr 19, 2011 · It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children. Additional injuries were sometimes present in the kidneys, heart, gastrointestinal tract, reproductive organs, ears and Mar 7, 2014 · In early 1961 doctors noticed an extraordinary increase in documented cases of children with a verity of birth defects, and they soon hypothesized that maternal exposure to Thalidomide during pregnancy caused these often-severe congenital abnormalities. "Thalidomide and Congenital Abnormalities. Selected References These references are in PubMed. Sep 1, 2012 · Dec 16, 1961, became one of the most important dates in the calendar of modern therapeutics when The Lancet published a letter from W G McBride, an Australian obstetrician, describing the tragedy of congenital abnormalities caused by use of thalidomide in pregnancy. Then in 1972, the company got a shock. 55 per 1,000. Teratogens are environmental agents that can disrupt normal development and cause birth defects when a pregnant woman is exposed. Thalidomide, a sedative whose ingestion by pregnant women led to the birth of abnormal babies in the late 1950s and early 1960s, is one of the more publicized examples of a chemical teratogen Mar 15, 2023 · Birth Defects Birth defects are differences in the way your child’s body develops. [37] Jul 1, 2020 · It has been established that thalidomide administration during the early stage of pregnancy significantly increases the incidence of miscarriage and the birth of malformed newborns with limb reduction anomalies and other defects, including congenital heart disease, ear and eye damage, and internal organ damage [1, 2]. J Bone Joint Surg Br. It was officially banned in 1961. Yet, to some this drug is a lifesaver, as it now enjoys renai Apr 3, 2019 · Background Between 1957 and 1961 the substance Thalidomide was sold in West Germany and taken by many women as a sedative during pregnancy. In Brazil, there are still babies born with thalidomide embryopathy (TE) because of leprosy Aug 1, 2018 · Strikingly, heterozygous loss of function mutations in SALL4 result in a human developmental condition that phenocopies thalidomide-induced birth defects such as absence of thumbs, phocomelia, defects in ear and eye development, and congenital heart disease. The Lancet 2 (December 16, 1961): 1358. 5% of babies. Thalidomide was used by pregnant women across 46 countries to manage symptoms of morning sickness. It examines the causes, mechanisms, and patterns of abnormal development. Understanding the problems thalidomide survivors face as they age can allow surgeons to support their unique healthcare issues and translate these principles of care to other congenital upper limb differences. Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did. " Letter to the Editor. The most stereotypical defect is symmetrical limb malformations such as phocomelia, although ear, eye and internal organ defects are also observed. What followed was the biggest man‐made medical disaster ever, where over 10,000 children were born with a range of severe and debilitating malformations. Increasingly, several gen-etic disorders with similar birth defects have been Aug 3, 2018 · More than 60 years after the drug thalidomide caused birth defects in thousands of children whose mothers took the drug while pregnant, Harvard Medical School scientists at Dana-Farber Cancer Institute have solved a mystery that has lingered ever since the dangers of the drug first became apparent: How did it produce such severe fetal harm? Sep 1, 1986 · The thalidomide experience produced a historically unique epidemic of previously and subsequently rare to extremely rare congenital malformations. Sir,—Congenital abnormalities are present in approximately 1. Phocomelia is a congenital condition that involves malformations of human arms and legs which result in a flipper-like appendage. Most of the babies were born with deformities of the arms and/or legs (phocomelia). Indeed a detailed Apr 19, 2011 · It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children. May 27, 2025 · Thus, impaired transitionings of the embryonic arteries appear to be responsible for a whole range of congenital long bone deficiencies. Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women. Despite this, the drug is now used successfully to treat a range of adult conditions, including multiple myeloma and complications of leprosy Sir,—Congenital abnormalities are present in approximately 1. 123. McBride brought the link between the drug thalidomide and birth defects to the Jun 2, 2012 · This year is the 50(th) anniversary of the discovery that the drug thalidomide causes birth defects and should therefore be considered as a teratogen. The compound produced a wide variety of congenital malformations in humans, which were initially detected by an association with a relatively rare limb defect labeled phocomelia. S. Some reports go even further and suggest it would be surprising if any embryo exposed to thalidomide during the time-sensitive window was unharmed (Newman, 1985; Stromland and Miller, 1992; Smithells and Newman, 1992). Merrell dismissed this unusual skewing toward limb defects as an increased tendancy to report any limb malformation after the thalidomide episode. A single pill is sufficient to produce teratogenic effects. Jun 1, 2025 · Today, we recognize that thalidomide exposure during specific gestational windows causes a range of congenital anomalies, including limb reduction defects (phocomelia), esophageal and duodenal atresia, facial hemangiomas, renal agenesis, cardiac defects like tetralogy of Fallot, cranial nerve abnormalities, and characteristic external ear From observations of the recent cases of congenital limb deformities attributed to thalidomide administered during the early weeks of pregnancy (that is, fifth and Teratology is the study of abnormal development and birth defects. The (R)-form has remedial properties, while the (S)-form is a teratogen, an agent that can cause birth defects. Amelia is an extremely rare birth defect marked by the complete absence of one or more limbs. 1 Before this, Widukind Lenz, a German paediatrician, had written to Chemie Grünenthal, the manufacturer of thalidomide Congenital heart disease is the leading cause of death in the first year of life. Apr 1, 2014 · Thalidomide, a drug capable of causing fetal abnormalities (teratogen), has caused greater than ten thousand birth defects worldwide since its introduction to the market as a pharmaceutical agent. What followed was the biggest man-made medical disaster ever, where over 10,000 children were born with a range of severe and debilitating malformations. Dysmelia. Although true phocomelia in the most severe Jan 1, 2022 · One of the consequences of the thalidomide-related epidemic of congenital defects was the need to expand rehabilitation and support services for those affected children and their families. [14][15][22][23] The U. Despite claims that the drug was safe during pregnancy, it was Mar 14, 2025 · Thalidomide is a drug that was used to treat morning sickness and sleeping problems in pregnant women in the 1950's and early 1960's. Aug 2, 2018 · Thalidomide’s harms, though well documented, have never been completely understood at the molecular level. Phocomelia, a limb atrophy, is the most common malformation linked to thalidomide, but all phocomelia cases aren’t caused by thalidomide. doi: 10. Tragically, the drug was at the heart of a pharmaceutical and political scandal when it turned out to cause severe birth defects. It caused an epidemic of severe birth defects that left children severely disabled. McBride Date: December 16, 1961 Source: McBride, W. Jan 15, 2016 · Thalidomide is a teratogenic drug that caused horrific birth defects when prescribed as an antiemetic to pregnant women in the 1960s. Understanding how thalidomide caused birth defects has remained a challenge for many years. Children with such defects are still being born Sep 23, 2025 · Thalidomide embryopathy refers to a syndrome resulting from in utero exposure to thalidomide, and is characterized by multiple fetal anomalies. The most common form of birth defects from thalidomide is shortened limbs, with the arms being more frequently affected. THE THALIDOMIDE Disaster in Germany In November 1961, German citizens were shocked to learn about thousands of babies born with severe birth defects in their country linked to a popular drug. Children with phocomelia present with their hands or feet directly attached to the trunk. "The most common form of birth defects from thalidomide is shortened limbs, with the arms being more frequently affected. The most stereotypical effect of thalidomide Thalidomide remains one of the world’s most notorious drugs due to the severe birth defects it induced in children between 1957 and 1962. This syndrome is the presence of deformities of the long bones of the limbs resulting in shortening and other abnormalities. Aug 1, 2018 · The medical community was slow to discover the danger of thalidomide because the drug gave rise to birth defects only when taken between the fourth and eighth weeks of pregnancy. Maternal pregestational diabetes has been associated with femoral hypoplasia-unusual facies syndrome (now more commonly called femoral-facial syndrome). The skeletal findings most frequently affect the limbs, particularly the upper limbs and hands. Thalidomide was later found to have therapeutic effects in several diseases, although the molecular Jun 9, 2025 · Examples of Congenital Abnormalities Caused by Teratogenesis Limb Abnormalities: Thalidomide exposure during pregnancy can cause severe limb abnormalities, including phocomelia and amelia. Possible birth defects include phocomelia, dysmelia, amelia, bone hypoplasticity, and other congenital defects affecting the ear, heart, or internal organs. This lead to miscarriages and infants been born with several severe malformations. However, despite the existence of several other drugs that are also human teratogens, thalidomide continues to cause concern among health professiona … May 26, 2009 · Half a century ago, thalidomide was used for its antiemetic properties by pregnant women worldwide. Yet thalidomide is now used around the world to successfully treat a wide range of conditions, including leprosy, Crohn's disease, multiple Jul 1, 2025 · Phocomelia is a rare condition that affects limb development. About the Author: Born in Sydney, Australia, in 1927, gynecologist and obstetrician William G. In the 1960s, developmental biologists began to inject thalidomide into animal embryos to trigger phocomelia. , Willert H. Nov 9, 2022 · The birth defects caused by the drug thalidomide can range from moderate malformation to more severe forms. Examples include congenital heart conditions, a cleft lip and Down syndrome. Thalidomide can get into semen, often at levels higher than found in blood. Jun 12, 2023 · Phocomelia is a rare congenital defect defined by the absence of intermediate segments of the extremity. Thalidomide as well as non-thalidomide limb deficiencies, as described recently for the 2022 Gerber Baby, are all the result of embryonic vascular dysgenesis. Fetal malformations include absence of ears and arms, deafness, phocomelia, defects in the face and palate, and malformations of the gastrointestinal system. Birth defects (congenital anomalies, congenital malformations) are a group of clinically If a male takes thalidomide, could it affect fertility (ability to get partner pregnant) or increase the chance of birth defects? Studies have not been done to see if thalidomide could affect male fertility or increase the chance of birth defects above the background risk. The teratogenic effects of maternal infections such as rubella and therapeutic drugs such as thalidomide were first reported by alert clinicians. As the Thalidomide is a potent teratogen that induces a range of birth defects, most commonly of the developing limbs. Learn what causes it, the signs to look for, and how it's managed. Jun 28, 2018 · The death of Australian doctor William McBride, who helped expose thalidomide as a drug that caused birth defects, hit the headlines on Thursday. The aim of this study was to describe the current situation of women impaired by Thalidomide induced embryopahty in North Rhine-Westphalia (Nordrhein-Westfalen), Germany, in Congenital defects due to thalidomideBr Med J. , Takahashi K. In this series of 61 patients with radial clubbed hands 8 had proven heart disease, with a wide variety of congenital cardiac defects. 8 is a billable diagnosis code used to specify oth congen malform syndromes due to known exogenous causes. It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children. Multiple Jul 30, 2021 · Sir,—Dr. The drug is now used in the treatment of leprosy and multiple myeloma. Jun 6, 2023 · Thalidomide, one of the most infamous drugs of all, caused severe birth defects in the children of pregnant women who took the drug for nausea in the 1950s. [37] Sep 25, 2018 · Abstract Thalidomide embryopathy results from the ingestion of thalidomide in the first trimester during pregnancy, causing multiple forms of congenital abnormalities of variable severity that involve all systems. Here we demonstrate that loss of immature blood vessels Abstract Historically, thalidomide-induced congenital malformations have served as an important example of the enhanced susceptibility of developing embryos to chemical perturbation. Food and Drug Administration (FDA) and other regulatory agencies have approved marketing of the drug only with an auditable risk evaluation and mitigation strategy that ensures that people using the drug are aware of the risks and avoid pregnancy; this applies to both men and women, as the drug can be transmitted in semen. Despite a general lack of satisfactory epidemiology, figures for incidence and a surprisingly finite yet wide-ranging pattern of malformations could be related to the timing of exposure to the drug in early pregnancy. Thalidomide-induced teratogenesis: History and mechanisms 2015, Birth Defects Research Part C Embryo Today Reviews. Thalidomide was developed in West Germany in the mid-1950s and was found to induce drowsiness and sleep. It occurred in the late 1950s and early 1960s when the drug thalidomide was widely prescribed to pregnant women to relieve morning sickness, leading to severe birth defects in thousands of newborns worldwide. 1136/bmj. The effect of thalidomide intake during Dec 11, 2019 · Thalidomide is a compound that was developed in the 1950s by the West German pharmaceutical company Chemie Grünenthal GmbH. Does the Thalidomide Society support people with similar impairments? Abstract Fifty years ago, prescription of the sedative thalidomide caused a worldwide epidemic of multiple birth defects. Mutations only in few genes have been linked to some cases of CHD. Thalidomide was used by pregnant women for morning sickness but was removed from the market because Jun 4, 2015 · Reports indicate that a single 50 mg tablet of thalidomide during the time-sensitive window is sufficient to cause birth defects in up to 50% of pregnancies. McBride (Dec. Here's why. 1963 Jan 12;1 (5323):123. In Aug 1, 2018 · More than 60 years after the drug thalidomide caused birth defects in thousands of children whose mothers took the drug while pregnant, scientists have solved a mystery that has lingered ever Thalidomide and other teratogens SIGNIFICANCE: Teratogenesis is the development of defects in the embryo or fetus caused by exposure to chemicals, radiation, or other environmental conditions. 5323. Abstract Even though a non-negligible portion of congenital eye anomalies has a clear genetic origin, an etiology is not found for most patients. Abstract Nearly 60 years ago thalidomide was prescribed to treat morning sickness in pregnant women. [22][failed This is where the concept of enantiomers comes in. May 8, 2017 · By November of 1961, physicians in Germany and Australia had independently discovered birth defects in infants whose mothers had taken thalidomide during early pregnancy. 1. Nov 27, 2020 · The most frequent congenital anomalies seen with amelia are other types of musculoskeletal defects, as well as intestinal, renal and genital defects; oral clefts; cardiac septal defects; and anencephaly. He reported his observations at meetings and in the medi-cal literature (Lenz,’61a,b,’62; Lenz and Knapp, ’62). Dr William McBride, who had first linked thalidomide to limb defects, reported to the Although some drugs are clearly recognized to cause birth defects (thalidomide being a notorious example), and others are generally recognized as safe, surprisingly little is known about most drugs' level of risk. Thalidomide is a sedative that was prescribed to pregnant women in the late 1950s and early 1960s to alleviate morning sickness, but it was later discovered to cause severe birth defects when taken during a critical period of fetal development. The mechanism by which thalidomide causes limb malformations and other developmental defects is a long-standing question. You can’t prevent most birth defects but you can reduce your risk by maintaining good health. Despite its global scope, thalidomide today stands for sharp contrasts: in the numbers of victims, in institutional responses to the disaster, and also—more generally—in regulatory approaches to potential risks and national cultures of reproductive Congenital limb defects are rare fetal anomalies with a birth prevalence of 0. May 24, 2023 · Recent work identifying thalidomide analogues that retain clinical benefits yet without the harmful effects are showing great promise. Abstract A study has been made of children born with radial clubbed hands, with reference to the incidence of coexisting congenital heart malformations. Syndromes are uncommon in amelia, but do occur, including Roberts syndrome and thalidomide embryopathy. Thalidomide was sold as a miracle drug to relieve nausea in pregnant women in the late 50s and early 60s. Prenatal medication exposure is recognized to be involved in fetal malformations and several medications are specifically known to alter eye morphogenesis during embryonic development leading to congenital eye defects. But the mechanisms behind Apr 8, 2025 · Historically, thalidomide-induced congenital malformations have served as an important example of the enhanced susceptibility of developing embryos to chemical perturbation. McBride’s concerns about thalidomide were subsequently confirmed by researchers in Europe, and the drug was banned around the world, saving countless infants from being born with birth defects. The mechanisms underpinning the teratogenic effects of thalidomide are unclear. [14] If administered to a pregnant patient, thalidomide can cause severe congenital defects or death. The drug was associated with serious deformities, including limb malformations, affecting an estimated 5,000 to 10,000 newborns worldwide, primarily in Thalidomide causes birth defects. The drug appeared to be unusually safe, with few Mar 15, 2023 · Skip to: What is Thalidomide? Thalidomide and Congenital Mutations Contemporary Uses of Thalidomide Thalidomide as a Treatment for Multiple Myeloma Thalidomide as a Treatment for Leprosy Phocomelia is a congenital disorder that presents with a reduction in length of the long bones of the legs and / or arms. Now, more than 60 years after thalidomide caused birth defects in thousands of children In the early 1960s an increasing number of infants were born with hypoplastic limb defects (Lenz,’85). Oct 9, 2015 · One challenge of modeling studies is that each exposure is examined in the absence of other known teratogens; the impact of addressing all these birth defects risk factors simultaneously is still unknown. Thalidomide was sold worldwide as a sedative over 60 years ago, but it was quickly withdrawn from the market due to its teratogenic effects. Its story has been repeated over and over – mostly wrong. Phocomelia is famously a teratogenic side effect of the drug "thalidomide," a drug first marketed to treat anxiety and morning sickness. Thalidomide caused a wide variety of birth defects, not one of which was unique to that drug. Although knowledge of birth defects risk factors has increased, the causes of the majority of birth defects remain unknown. It was originally intended as a sedative or tranquiliser but was soon used for treating a wide range of other conditions, including colds, flu, nausea and morning sickness in pregnant people. 1969 Aug;51 (3):399–414. We explored and reviewed the Q86. " Nearly 60 years ago thalidomide was prescribed to treat morning sickness in pregnant women. In Jun 12, 2023 · In particular, the FDA Black Box Warning involves embryo-fetal toxicity. vhufufiowsoajzl6ooj3tgoy13dxuczpmfxhc2gtbxvv2k9ve5a