- What Is THALOMID REMS?
- Other Teratogenic Drugs
- Grading System
- Causes of Teratogenic Effects
- Diagnosing Birth Defects
- Thalidomide is the earliest known drug that causes severe life-threatening birth defects.
- Earlier in the 1950s and 1960s, thalidomide was used to cure morning sickness in pregnant women. It was prescribed for pneumonia and cold-like symptoms.
- Later, it was revealed that women who were on thalidomide during pregnancy gave birth to children with severe disabilities, most commonly limb deformations, blindness, heart defects, deafness, and brain damage. Thalidomide even caused the death of the unborn child.
What is THALOMID REMS?
The U.S. Food and Drug Administration has approved a program called THALOMID (thalidomide) Risk Evaluation and Mitigation Strategy (REMS) which was earlier known as the System for Thalidomide Education and Prescribing Safety (STEPS). This program aims to ensure that pregnant women do not use thalidomide, and women should not become pregnant while on thalidomide.
The guidelines for THALOMID REMS are as follows:
- All men and women who are on prescription thalidomide and who find it difficult to get pregnant must be registered with THALOMID REMS.
- Thalidomide should be prescribed only by a doctor who is registered with THALOMID REMS.
- Prescription thalidomide should be refilled by a pharmacy that is registered with THALOMID REMS.
What are the other potential teratogenic drugs?
Apart from thalidomide, many drugs were found to be teratogenic, such as:
- Anticonvulsant medications such as:
- Benzodiazepines (anti-anxiety medications) such as:
- Anti-thyroid medications such as:
- Over-the-counter nonsteroidal anti-inflammatory drugs such as:
- Hormone diethylstilbestrol or des (a synthetic form of estrogen that was given to prevent miscarriage or premature labor in pregnancy between 1940 and1971)
- Angiotensin-converting enzyme inhibitors (treats high blood pressure)
- Angiotensin II antagonist (treats blood pressure and heart failure)
- Certain antibiotics such as:
- Sulfa drugs
- Statins such as:
- High doses of vitamin A
- Lithium (antidepressant)
- Isotretinoin (treats acne)
- Male hormones
- Chemotherapy drugs
- Warfarin (blood-thinning drug)
All the drugs mentioned above are useful to treat various serious medical conditions. These drugs should be taken cautiously in women who are planning for pregnancy or who are pregnant. Some medications for chronic diseases such as asthma, high blood pressure, or epilepsy may not be avoidable during pregnancy, so close observation by a doctor while taking these medications during pregnancy is highly recommended.
The list of teratogenic drugs is not confined to this. Many other drugs are known to cause birth defects.
Evidence-based grading system for teratogenic drugs
The U.S. Food and Drug Administration uses an evidence-based grading system as part of product labeling to grade drugs based on their potential for teratogenic risk. Drugs in group A have no demonstrated danger, whereas those in categories D and X have a definite risk and positive evidence of fetal harm.
- A: Prescription drugs that have been used by a large number of pregnant women with no evidence of an increased risk of birth abnormality.
- B: Drugs that have only been used by a small number of pregnant women. There is a shortage of human data; hence, they are further classified based on existing data from animal studies.
- B1: Animal studies have reported no increased risk.
- B2: Although animal studies are limited, there does not appear to be an elevated risk.
- B3: Animal studies report an increased risk although it is unclear whether these drugs are dangerous to humans.
- C: These drugs may harm the fetus while not causing birth abnormalities. These effects could be reversed.
- D: Drugs that have caused or are likely to cause birth abnormalities; however, the health benefits may outweigh the risks.
- X: Drugs that are associated with a high risk of birth abnormalities and should not be used during pregnancy.
Drugs that come under category D must be used only if:
- The mother is at high risk in the absence of the drug.
- The advantage of drugs is higher than the risk it poses.
Drugs that come under category X must be avoided completely in a pregnant mother because they cause severe birth defects.
A safer medicine can be substituted with harmful drugs to treat certain medical conditions during pregnancy such as:
Latest Pregnancy News
Daily Health News
How teratogenic effects are caused by drugs in the fetus?
Most of these drugs taken by the pregnant mother cross the placenta and produce harmful effects on the fetus. Although some drugs may not cross the placenta, they still harm the fetus by affecting the placenta or uterus.
- They can have an immediate effect on the fetus, causing harm, which results in birth abnormalities or death.
- They can affect the function of the placenta, mainly by causing blood vessels to narrow (constrict) and limiting the delivery of oxygen and nutrients from the mother to the fetus. As a result, the newborn may be underweight and undeveloped.
- They can cause the uterine muscles to contract violently, harming the fetus indirectly by limiting its blood supply or prompting premature labor and delivery.
- They can have an indirect effect on the fetus. Drugs that lower the mother's blood pressure may restrict blood flow to the placenta, reducing the fetus's availability of oxygen and nutrients.
The teratogenic effect of a drug depends on various factors such as:
- The developmental stage of the fetus
- The drug's potency and dosage
- The extent to which the drug can cross the placenta
- The mother's genetic makeup influences how much of the medicine is active and available
Are birth defects diagnosed before birth?
It is not always possible to detect all birth abnormalities while the baby is still in the womb. Many birth defects, however, may be diagnosed through various tests including high-resolution ultrasounds and genetic tests.
The only preventive measure is to avoid teratogenic drugs before or during pregnancy and quit consumption of alcohol, tobacco, and other illicit drugs.
Health Solutions From Our Sponsors
Teratology and Drug Use During Pregnancy: https://emedicine.medscape.com/article/260725-overview#a2
Birth Defects: https://my.clevelandclinic.org/health/diseases/12230-birth-defects
Top What Drug Causes Severe Birth Defects Related Articles
Birth DefectsBirth defects have many causes and currently, are the leading cause of death for infants in the first year of life. Some of the causes of birth defects include genetic or chromosome problems. Exposure of the mother to rubella or German measles during pregnancy, or using drugs or alcohol during pregnancy. The treatment for birth defects depends upon the condition of the effected child.
Pregnancy Discomforts: Common CausesDuring pregnancy, most women will experience discomforts during the 1st, 2nd, and 3rd trimesters. Common causes of discomforts during pregnancy include nausea and vomiting (morning sickness), fatigue, breast swelling and pain, hemorrhoids, stretch marks, mood swings, dizziness, migraines, tooth pain and bleeding gums, and pica.
Common causes of pregnancy discomforts include constipation, heartburn, indigestion, reflux, varicose veins, abdominal pain, problems sleeping, congested or bloody nose, and flu like body aches.
16 Early Signs & Symptoms of Pregnancy: Could You Be Pregnant?What are the early signs and symptoms of pregnancy? Can you know before your missed period? Read about nausea and vomiting (morning sickness), bloating, tender breasts, and more. Explore first trimester symptoms of pregnancy and learn what week pregnancy symptoms start.
Am I Pregnant QuizWhat are early pregnancy symptoms? In some women, symptoms range from a missed period to feeling lightheaded. Others may experience typical "morning sickness" and food cravings. Could you be pregnant? Take the quiz!
Exercise & PregnancyPregnancy exercises and workouts for moms-to-be include Kegel exercises and prenatal yoga. A prenatal workout is an important part of healthy living. Try these safe exercises for pregnancy.
How Does Pregnancy Affect Mental Health?Pregnancy can be a time of great joy and happiness. Different women respond to pregnancy differently, but pregnancy can affect some womens' mental health negatively.
Pregnancy: Multiple Births, Twins, Triplets, and MoreMultiple births occur when a woman bears twins, triplets, or even more babies during pregnancy. More multiples are born today thanks to assisted reproductive technology (ART), including in vitro fertilization using fertility drugs. Women carrying multiples often give birth via C-section.
Pregnancy Flu Shot Side Effects and SafetyThe flu shot is safe for pregnant women and protects both mother and unborn baby from illness. Pregnant women should not, however, receive the nasal-spray flu vaccine.
Pregnancy Myths and Facts QuizBeing pregnant is a delicate time for both mother and baby. Take this pregnancy myths and facts quiz to separate the myths and facts about being pregnant, and learn the truth behind healthy pregnancies!
Pregnancy TestThere are two types of pregnancy tests. One is done in the doctor's office, and tests the blood for the pregnancy hormone, hCG. The other type of pregnancy test can be bought over-the-counter and checks the urine for this hormone. There are many types of home pregnancy tests to choose from. Accuracy of home pregnancy tests depend on how, when, and who uses them, and the brand. It is possible to have a false-negative with a home pregnancy test.
Pregnancy: Birthing, Breastfeeding, and Parenting ClassesPreparing for a baby is an important step in parents' lives. Choosing the right birthing class and method (Lamaze, Bradley, etc.) is important for the mother, baby, and father or support giver. Parenting classes are also information for first time parents. Information is provided about diapering, feeding, and bathing your baby as well as the different stages of child development.
Pregnancy: Prenatal Care and TestsPrenatal care is important for the health of both mother and baby. Common prenatal tests include ultrasound, amniocentesis, screening for group B strep and chronic villus sampling. Prenatal care also helps detect health conditions related to pregnancy, such as preeclampsia and gestational diabetes.
What Foods Should I Eat During My First Trimester of Pregnancy?What to know about diet during the first trimester. Learn more about how to protect and fuel your body and baby during this exciting time.
Pregnancy: 7 Common Third Trimester TestsTesting is often recommended during the third trimester of pregnancy. These tests are designed to ensure the health and safety of both the child and mother. Common tests during the third trimester of a woman's pregnancy include:
- group B streptococcus screening,
- electronic fetal heart monitoring,
- nonstress test,
- contraction stress test, and
- a biophysical profile.
Tubal Pregnancy PictureA pregnancy that is not in the usual place within the uterus but is located in the Fallopian tube. See a picture of Tubal Pregnancy and learn more about the health topic.
What Vitamins and Supplements Should I Avoid During Pregnancy?You should always clear it with your obstetrician before taking any vitamins or supplements while pregnant.
What Are the Most Common Birth Defects?A birth defect is a health condition that is present since birth. Birth defects may change the shape or function of one or more parts of the body. They can cause problems in overall health.