Victor R. Claveau, MJ
“Teratogen” is a term that refers to any drug or other substance with the potential of interfering with the development of a fetus causing birth defects. Teratogens are thought to have the ability to affect the baby about 10 to 14 days after conception.
Teratology (from the Greek, meaning monster, or marvel) is the study of these malformations or serious deviations from the norm.
“Birth defect” is a widely-used term for a congenital (existing or dating from birth) malformation, i.e., a congenital, physical anomaly which is recognizable at birth, and which is significant enough to be considered a problem. These abnormalities lead to mental or physical disabilities or are fatal. A typical combination of malformations affecting more than one body part is referred to as a malformation syndrome.
According to the Centers for Disease Control, there are more than 4,000 different known birth defects ranging from minor to serious, and although many of them can be treated or cured, they are the leading cause of death in the first year of life, accounting for more than 20% of all infant deaths. In the United States about 3% of babies or one of every 33 is born with a birth defect.[i] Babies born with birth defects have a greater chance of illness and long term disability than babies without birth defects.[ii] Seven to ten percent of all children will require extensive medical care to diagnose or treat a birth defect.[iii]
According to the March of Dimes Global Report on Birth Defects, every year an estimated 8 million children—6 percent of total births worldwide—are born with a serious birth defect of genetic or partially genetic origin. Additionally, hundreds of thousands more are born with serious birth defects of post-conception origin due to maternal exposure to environmental agents. At least 3.3 million children less than 5 years of age die annually because of serious birth defects and the majority of those who survive may be mentally and physically disabled for life.[iv] According to the CDC, about 70% of birth defects have unknown causes.[v]
Little research has been done to evaluate the birth control pill’s potential for causing birth defects. Most birth defects happen in the first 3 months of pregnancy, when the organs of the baby are forming; the most important stage of development. Hormonal changes during pregnancy can also have very serious negative effects on a developing baby. Few manufacturers of birth control pills are willing to publicly recognize these dangers, and warn their consumers.
One such birth defect is Camptomelic Syndrome: “The camptomelic syndrome is a severe malformation disorder with abnormal cartilage and bone formation. The most intriguing feature of camptomelic syndrome is sex reversal observed in a significant proportion of phenotypic girls” (physically female but genetically male), report researchers in the American Journal of Obstetrics and Gynecology. These researchers suspect that this syndrome may be caused by the negative effects of oral contraceptives on male preborn children, since they have identified two cases where the syndrome occurred and the mothers were taking birth control pills after the pregnancy had begun”[vi] (emphasis mine).
Planned Parenthood claims, “It is unlikely that taking the pill during early pregnancy will increase the risk of birth defects.” [vii] Further, PP states, “There is no evidence that the pill puts women at risk of having a child with birth defects—either while she is using it or after she stops using it.”[viii]
In 1975, the Food and Drug Administration created guidelines for drug companies to follow in regards to labeling medications about their effects on reproduction and pregnancy.
Five categories were established:
Category A – Controlled studies show no risk
Category B – No evidence of risk in humans
Category C – Risk can not be ruled out
Category D – Positive evidence of Risk
Category X – Contraindicated in Pregnancy
Category D includes drugs which, studies in humans, or investigational or post marketing data, have demonstrated fetal risk. Nevertheless, potential benefits from the use of the drug may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.
Category D drugs include progesterone, tetracycline, aspirin, cortisone, tretinoin (Retin-A), and lithium.
Category X drugs include oral contraceptives and estrogens as well as medroxyprogesterone, simvastatin, trazolam, and warfarin.
Pregnancy Category X drugs are contraindicated in pregnancy as they have been proven to cause birth defects: “Studies in animals or humans have demonstrated fetal abnormalities and/or there ispositive evidence of human fetal riskbased on adverse reaction data from investigational or marketing experience, andthe risks involved in use of the drug in pregnant women clearly outweigh potential benefits”[ix](emphasis mine).
Sixty percent of drugs in the Physician’s Desk Reference have not been assigned FDA pregnancy categories.[x]
The FDA fails in its civic responsibility when it neglects to require manufactures of oral contraceptives to warn an unsuspecting public that birth control pills can certainly cause birth defects in an unborn baby.
The Physician’s Desk Reference (2008) lists the following combination oral contraceptives in the Category X classification:
LYBREL™ (Wyeth)
(90 mcg levonorgestrel and 20 mcg ethinyl estradiol)
MIRCETTE® (Duramed)
(desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets
ORTHO TRI-CYCLEN® LO TABLETS (Ortho Women’s)
(norgestimate/ethinyl estradiol)
ORTHO TRI-CYCLEN® TABLETS (Ortho Women’s)
(norgestimate/ethinyl estradiol)
ORTHO EVRA® (Ortho Women’s)
(NORELGESTROMIN / ETHINYL ESTRADIOL TRANSDERMAL SYSTEM)
SEASONIQUETM (Duramed)
(levonorgestrel / ethinyl estradiol tablets)
0.15 mg / 0.03 mg and (ethinyl estradiol tablets) 0.01 mg
YASMIN® 28 TABLETS (Bayer HealthCare Pharmaceuticals)
(drospirenone and ethinyl estradiol)
YAZ® (Bayer HealthCare Pharmaceuticals)
(drospirenone and ethinyl estradiol) Tablets
Additionally, the MIRENA® IUD (Bayer HealthCare Pharmaceuticals) (levonorgestrel-releasing intrauterine system) is also listed in Category X.
[i] http://www.cdc.gov/ncbddd/bd/faq1.htm#chanceofBD
[ii] Ibid.
[iii] Dicke JM (1989). “Teratology: principles and practice”. Med. Clin. North Am. 73 (3): 567-82. PMID 2468064
[iv] The March of Dimes Global Report on Birth Defects, http://www.marchofdimes.com/professionals/871_18587.asp
[v] Centers for Disease Control and Prevention (CDC). “Birth Defects: Frequently Asked Questions.” March 21, 2006.
[vi] Myungduk Roger Kim, M.D., M.P.H., et al., “A Genetic Male Infant With Female Phenotype in Camptomelic Syndrome: A Possible Relationship to Exposure to Oral Contraceptives During Pregnancy,” American Journal of Obstetrics and Gynecology, Vol. 172, #3, 3/95, pp. 1042-1043)
[vii] http://www.plannedparenthood.org/health-topics/birth-control/pill-4228.htm
[viii] Ibid.
[ix] http://www.fda.gov/fdac/features/2001/301_preg.html#categories
[x] “National patterns of medication use during pregnancy” by Euni Lee, Pharm.D., Ph.D., Mary K. Maneno, B.S., Leah Smith, Pharm.D., and others, in the August 2006 Pharmacoepidemiology and Drug Safety 15, pp. 537-545. Quoted by U.S. Dept. of Health & Human Services, http://www.ahrq.gov/research/may07/0507RA19.htm