Which of the following is considered to be a teratogenic drugs?

If a drug is classified as being teratogenic, it means that medication has the potential to cause developmental malformations or birth defects to a fetus when taken by a pregnant woman. It is part of the FDA’s job to study the effects medications may have on fetal development so that they can properly warn doctors and their patients about possible birth defect side effects, allowing them to decide whether different medications may be more appropriate for expecting mothers.

The FDA has created a system to classify teratogenic drugs according to the potential risk to a baby. The five categories used to represent the possible threat of medications when taken by pregnant women are:

Category A

Multiple tests and studies have shown that drugs in this category show no evidence of risk to a baby when taken during the first trimester of pregnancy. This is the safest category of drugs in light of threats to fetal development.

Category B

Medications in Category B have been placed in this class for one of two reasons:

  • No human studies have been conducted, but studies conducted on animals show no risk to a fetus
  • Human studies show no risk to a fetus, but studies performed on animals may indicate a risk

Category C

Doctors are advised by the FDA to prescribe these drugs to pregnant women only when the benefits can be shown to outweigh the risks. The FDA may add a drug to the Category C class if:

  • No studies have been conducted on humans or animals
  • Or animal studies indicate a possible risk to a fetus but no human studies are available to confirm this

Category D

Though the benefits of these drugs to mothers may outweigh the risks, there is evidence that they may harm a fetus. These drugs may be prescribed to pregnant women if no other drugs are available or if they are necessary to treat a life-threatening illness.

Category X

These drugs have been shown in both human and animal studies to pose a serious risk to a fetus, or there is data from actual pregnancies that indicate this risk.

Doctors should not prescribe these drugs to women who are or who may become pregnant, as the substantial risks outweigh any proposed benefits.

A number of women and families with children whose birth defects may be attributed to medications taken during pregnancy have chosen to file personal injury lawsuits in pursuit of compensation for medical bills and other damages. If you believe your child’s birth defect or developmental delay may be linked to a medication taken while the child was developing in the womb, contact the Law Offices of Melinda J. Helbock, A.P.C. to schedule a legal consultation where you can learn more about your rights.

An estimated 890 000 children aged 1–5 years, or 4.4% of the US population in that age range, have elevated blood lead levels. Successful prenatal identification of lead-exposed women would allow for removal of lead, and a lead-free environment for newborns. Once exposed, treatment includes nutritional interventions (iron and calcium supplementation), a reduced-fat diet, and frequent meals. Use of chelating agents, which competitively bind lead and remove it from the body, may be necessary. Timely intervention prevents progression and improves outcome.

A teratogen is any agent that causes an abnormality following fetal exposure during pregnancy. Teratogens are usually discovered after an increased prevalence of a particular birth defect. For example, in the early 1960’s, a drug known as thalidomide was used to treat morning sickness. Exposure of the fetus during this early stage of development resulted in cases of phocomelia, a congenital malformation in which the hands and feet are attached to abbreviated arms and legs.

Teratogens can also be found at home or the workplace. The effect is related to type of agent, dose and duration and time of exposure. The first half of pregnancy is the most vulnerable. Teratogenic agents include infectious agents (rubella, cytomegalovirus, varicella, herpes simplex, toxoplasma, syphilis, etc.); physical agents (ionizing agents, hyperthermia); maternal health factors (diabetes, maternal PKU); environmental chemicals (organic mercury compounds, polychlorinated biphenyl or PCB, herbicides and industrial solvents); and drugs (prescription, over- the-counter, or recreational). In general, if medication is required, the lowest dose possible should be used and combination drug therapies and first trimester exposures should be avoided.

The types or severity of abnormalities caused by a teratogenic agent is also dependent on the genetic susceptibilities carried by the mother and fetus. For example, variation in maternal metabolism of a particular drug will determine what metabolites the fetus is exposed to and the duration of exposure. The genetic susceptibility of the fetus to a particular teratogenic agent will also have an effect on the final outcome.

Two of the leading preventable causes of birth defects and developmental disabilities are alcohol and smoking. Alcohol use in pregnancy has significant effects on the fetus and the baby. Alcohol can pass from the mother’s blood stream through the placenta to the fetus. Since alcohol is broken down more slowly in a fetus than in an adult, alcohol levels tend to remain high and stay in the baby’s body longer. Birth defects associated with prenatal exposure to alcohol can occur in the first three to eight weeks of pregnancy, before a woman even knows that she is pregnant.

Fetal alcohol syndrome is a group of abnormalities in babies born to mothers who consume alcohol during pregnancy. It is the most common known non-genetic (non-inherited) cause of mental retardation in the U.S. Several educational materials in English and Spanish are available from the CDC at http://www.cdc.gov/ncbddd/fas/faspub.htm.

In 2001, the estimated prevalence of smoking during pregnancy for all U.S. women was 11.4%, ranging from 3.9% in DC to 26.2% in West Virginia. Smoking nearly doubles a woman’s risk of having a low birth-weight baby as a result of poor growth before birth, preterm delivery or a combination of both. Premature and low birth-weight babies face an increased risk of serious health problems during the newborn period, chronic lifelong disabilities (e.g., cerebral palsy, mental retardation) and possibly death. More recent studies have suggested a possible link between prenatal smoking exposure and behavioral problems in later childhood and adolescence.

In addition, almost three percent of pregnant women use illicit drugs such as marijuana, cocaine, Ecstasy and other amphetamines, and heroin. These drugs can cause low birth-weight, withdrawal symptoms, birth defects, or learning or behavioral problems.

More information about specific teratogens can be found the following web-sites:

  • Reprotox–an online Information System on Environmental Hazards to Human Reproduction and Development http://reprotox.org/

    Which is considered to be a teratogenic drugs?

    A drug is a teratogen if its administration to the pregnant mother, directly or indirectly, causes a structural or functional change in the fetus or child. Organ formation within the fetus occurs in the first 3 months of pregnancy, teratogenic drugs taken in this period therefore tend to cause structural defects.

    What are the 4 types of teratogens?

    Teratogens are classified into four types: physical agents, metabolic conditions, infection, and finally, drugs and chemicals. The word teratogen originates from the Greek word for monster, teratos.

    Which of the following is true regarding drugs as teratogens mcq?

    Which of the following is true regarding drugs as teratogens? All illegal drugs are teratogens. The FDA will not approve prescription drugs if they are teratogens. If a medical drug is a teratogen, it must be prescribed by a doctor and is not available over the counter.