Risk management of teratogenic medicines: A systematic review

Abstract

Aim: To systematically identify studies of implementing risk management measures when prescribing teratogenic medicines for women of childbearing age and studies reporting risk perceptions of teratogenic medications. Methods: MEDLINE, CINAHL, Scopus, EMBASE, and International Pharmaceutical Abstracts were searched. Studies were included in the risk management section if they reported any of the following risk management measures: teratogenic counseling, contraceptive counseling, pregnancy testing before starting treatment, pregnancy testing during treatment, use of contraception before starting treatment, and use of contraception during treatment. Studies were included in the perceptions section if they reported perceived teratogenic risk as numerical value. Results: Fifty-five studies were included in the risk management section and seven studies were included in the perceptions sections. Prevalence of risk management measures varied as follows: teratogenic counseling (9.5%-99.3%), contraceptive counseling (6.1%-98%), pregnancy testing before starting treatment (0%-95.1%), pregnancy testing during treatment (12.7%-100%), contraception use before starting treatment (15.7%-94%), and contraception use during treatment (1.7%-100%). A proper estimation of the teratogenic risk was reported for thalidomide (by general practitioners and obstetric/gynecologists), for etretinate (by pregnant women), and for misoprostol (by pregnant and nonpregnant women). An underestimation was reported for warfarin and retinoids (by general practitioners and obstetric/gynecologists). And overestimation was reported for thalidomide, valproate, lithium, isotretinoin, phenytoin, warfarin and etretinate by different populations. Conclusion: Considerable variation in the implementation of risk management measures when prescribing teratogenic medicines to women of childbearing age is reported in the literature. A common tendency to overestimate the risk of teratogenic medications was evident.

Guideline for the diagnosis, treatment and long-term management of cutaneous lupus erythematosus

“…Mycophenolic acid and methotrexate should be avoided because of known or possible teratogenic properties [125]. Retinoids and thalidomide have definite teratogenic effects and are contraindicated in women planning pregnancy or during pregnancy [132,133]. Pregnancy should be avoided during treatment with systemic retinoids and within 3 months after withdrawal of isotretinoin or 2 years after withdrawal of acitretin.…”

Women’s experiences of over-the-counter and prescription medication during pregnancy in the UK: findings from survey free-text responses and narrative interviews

“…While prescribers need to balance maternal benefit with potential fetal harm when prescribing in pregnancy, women’s individual circumstances were not always considered, and they were not fully engaged in decision making. Possibly reflecting the tendency of health professionals to overestimate the teratogenic potential of drugs, 25 we found many examples where health professionals used fear of fetal harm to justify a refusal to prescribe or dispense otherwise recommended medications. This had a significant impact not only on women’s health, but on their emotional well-being with one reporting they were made to feel like the ‘world’s worst mother’.…”

How Can Pregnant Women Reduce the Teratogenicity of Air Pollution?

“…In the embryonic period, the effect of teratogens is very high. 2 Teratogens include not only drugs, but also environmental factors which can have important effects during this period of pregnancy. Despite avoiding drugs such as lithium, tranquilizers, anti-epileptic drugs, and smoking, pregnant mothers should be in an environment with an acceptable quality index in order to avoid the harmful effects of pollutants on the fetus, including low birth weight, respiratory failure, cleft palate, heart failure, spina bifida, and cancer.…”

“…Despite avoiding drugs such as lithium, tranquilizers, anti-epileptic drugs, and smoking, pregnant mothers should be in an environment with an acceptable quality index in order to avoid the harmful effects of pollutants on the fetus, including low birth weight, respiratory failure, cleft palate, heart failure, spina bifida, and cancer. 2 Apart from congenital or environmental teratogens, of importance is the awareness of pregnant women about the risk factors and preventive measures in the face of known teratogens. Prevention of the effect of teratogens can reduce the number of children with congenital disease, decrease material and psychological costs, and create a healthy society.…”