Drug use in pregnancy; a point to ponder!

Abstract

Pregnancy is a special physiological condition where drug treatment presents a special concern because the physiology of pregnancy affects the pharmacokinetics of medications used and certain medications can reach the fetus and cause harm. Total avoidance of pharmacological treatment in pregnancy is not possible and may be dangerous because some women enter pregnancy with medical conditions that require ongoing and episodic treatment (e.g. asthma, epilepsy, hypertension). Also during pregnancy new medical problems can develop and old ones can be exacerbated (e.g. migraine, headache) requiring pharmacological therapy. The fact that certain drugs given during pregnancy may prove harmful to the unborn child is one of the classical problems in medical treatment. In 1960's pregnant ladies who ingested thalidomide gave birth to children with phocomalia. Various other examples of teratogenic effects of drugs are known. It has been documented that congenital abnormalities caused by human teratogenic drugs account for less than 1% of total congenital abnormalities. Hence in 1979, Food and Drug Administration developed a system that determines the teratogenic risk of drugs by considering the quality of data from animal and human studies. FDA classifies various drugs used in pregnancy into five categories, categories A, B, C, D and X. Category A is considered the safest category and category X is absolutely contraindicated in pregnancy. This provides therapeutic guidance for the clinician. This article focuses on various aspects relating to drug use during pregnancy.

Drug Utilization Pattern and Potential Teratogenicity Risk among Pregnant Women Visiting Antenatal Clinic: The Case of a Primary Hospital

“…4,5 Pharmacological treatment should be avoided in pregnancy, unless absolutely necessary. [6][7][8] Pregnant women are generally excluded, for ethical reasons, from randomized clinical trials in drug development. This has left questions about the safety of new medications on the developing fetus unanswered, upon drug approval and marketing.…”

Pregnancy and inflammatory bowel diseases: Current perspectives, risks and patient management

“…The Food and Drug Administration (FDA) has established five distinguishing categories to designate the potential for a drug to cause birth defects if used during pregnancy [66] and reflect both documentation reliability and relative risk to benefit ratio considerations (Table 1).…”

Impact of educational session on knowledge and attitude towards teratogenicity among undergraduate medical students: a comparative study

“…7,8 Teratogenic drugs are responsible for <1% of birth defects. 9 Previous studies had reported only 24% of physicians to be confident while prescribing for a pregnant woman. 10 During pregnancy 59% of women are prescribed with drugs other than vitamin and mineral supplements.…”

“…10 During pregnancy 59% of women are prescribed with drugs other than vitamin and mineral supplements. 9 Category D drugs were used in 0.41% to 23% and category X drugs were used in 0 to 2.9% of the cases during pregnancy. 7,11 There is a need for the early exposure of students to the concept of teratogenicity which will bridge the gap in their knowledge as well as which will lay the foundation for safe prescribing for a pregnant woman.…”