An estimated five million pregnancies occur in the U.S. yearly. Women typically take approximately three to five medications. So, knowing if a drug is safe for mother and child during pregnancy and breast feeding is crucial.
Pregnancy Categories outlined by The U.S. Food and Drug Administration (FDA) are as follows – A, B, C, D or X – which is used to denote their safety to a woman and her fetus.
Studies showed no fetal risk. There are very few drugs listed in Category A. Prenatal vitamins are an example.
Studies indicate no fetal risk, but findings are based on animal studies, not human studies. Or effects have been demonstrated in animals, but not in well-controlled human studies.
Category C rating is given to drugs that have been shown to be harmful in animal studies but no studies have been conducted on pregnant humans. Many medications that pregnant women use fall into this category.
There is evidence of fetal risk, but benefits are thought to outweigh risks.
Fetal risks outweigh benefits.
Common Birth Defects
Cleft palate and lip is a treatable birth defect that affects the upper lip and the roof of the mouth (palate). It happens when the tissue that forms in the roof of the mouth and upper lip don’t completely fuse together before birth.
Spina bifida – is a birth defect that afflicts approximately 1 in every 1,000 children born in the United States each year. The condition is characterized by a malformation of one or more vertebrae that surround the spinal cord.
Heart defects – About 35,000 infants (1 out of every 125) are born with heart defects each year in the United States, according to the March of Dimes. In most cases, scientists do not know what makes a baby’s heart develop abnormally. Genetic and environmental factors appear to play roles, as well as certain medications as noted above.
Common Drugs Associated With Birth Defects
Topamax – In March, the FDA warned about an increased risk of oral clefts in infants exposed to Topamax or generic rivals, during the first trimester of pregnancy. Topamax is an anti-seizure medication also approved for migraine treatment which will now be labeled in Category D.
Depakote – In 2004, women were warned not to take Depakote during pregnancy because of an increased risk of birth defects and other problems. Death of the fetus, birth defects, and developmental delays, such as walking and speech delays, occurred in 28% of children whose mothers took Depakote. You can read more on WebMD.
OxyContin / Oxycodone (active ingredient in Oxycontin) – These drugs fall into Category B. They do not appear to increase risk of birth defects. However, OxyContin is a narcotic and should not be used during the end of a pregnancy as it may cause narcotic withdrawal to the infant after delivery.
Clomid – Category X, studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant.
Over-the-counter (OTC) Drugs – Several OTC drugs are also dangerous during pregnancy. Please be sure to read all labels and contact your doctor or local pharmacy if you are unsure.
Significance of When the Drug Was Taken
Before Pregnancy – If you were taking prescription medications before you became pregnant, please consult your health care provider about the safety of continuing these medications during pregnancy.
During 1st Trimester (Months 1-3) Certain drugs taken early in pregnancy may act in an all-or-nothing fashion, killing the fetus or not affecting it at all. It is particularly vulnerable to birth defects between the 3rd and the 8th week after fertilization, when its organs are developing. Topamax, is a drug known to be dangerous when taken in the first trimester.
During 2nd Trimester (Months 4-6) All drugs have different degrees of risk. For instance, Diazepam taken during the 2nd trimester can also increase risk of cleft lip or palate.
During 3rd Trimester (Months 7-9) Non-steroidal anti-inflammatory drugs such as ibuprofen and Naproxen should not be taken during the 3rd trimester.
The FDA has highlighted several resources that can help you find out more about the effects a medication might have when taken during pregnancy.
Other Birth Defects Associated with Medications Taken During Pregnancy
Neural Tube Defects – birth defects of the brain and spinal cord such as spina bifida and Anencephaly.
Craniofacial Defects – include cleft lip and cleft palate, which are among the most common of all birth defects.
Cardiovascular Malformations – another name for heart defect and congenital heart disease.
Hypoplastic Left Heart Syndrome – occurs when parts of the left side of the heart do not develop completely.
Hydrocephaly – abnormal expansion of cavities (ventricles) within the brain.
Gastroschisis – when an infant’s intestines stick out of the body through a defect on one side of the umbilical cord.
Anencephaly – open cranium with the absence of a brain.
Esophageal atresia – closed esophagus.
Omphalocele – protrusion of part of the intestine through the abdominal wall.
Craniosynostosis – premature fusion of the skill bones.
Dandy Walker malformation – defect of the brain
Cloacal extrophy – involves multiple abnormalities of the gastrointestinal and genitourinary tracts.
Autism spectrum disorder – a developmental disorder that appears in the first 3 years of life, and affects the brain’s normal development of social and communication skills.
Penoscrotal hypospadia – Hypospadias refers to a urethral pee-hole which is located along the underside, rather than at the tip of the penis. Distal hypospadias pee-hole may be located on the underside of the penis, in the glands. A male with may have to urinate while sitting down, rather than standing up. He may also be prone to urinary tract infections with this disorder.
Down’s Syndrome – a genetic condition in which a person has 47 chromosomes instead of the usual 46. Symptoms vary from person to person and can display from mild to severe.
Club foot – a congenital deformity involving one foot or both.