Is it safe to use during pregnancy
If you read this website as a layperson
We have reduced the description of the individual drugs to a condensed representation of the state of knowledge in order to facilitate decision-making for treating doctors, advising pharmacists and other medical specialists. Without a professional background, our compressed information can lead to misinterpretations of the risk or tolerance of a drug. Therefore, laypeople are not allowed to use this internet platform as a basis for unauthorized decisions. The information on this Internet platform is not a substitute for a doctor's visit.
The information on the drug pages must not be used as a basis for terminating a pregnancy. If in doubt, you should contact us - via our online questionnaire or by phone.
If you, as a nursing mother, have a question about medication and have previously obtained information on this website, please contact your pediatrician or gynecologist, midwife, lactation consultant or pharmacy. Then please refer to our information offer.
Medicines and pregnancy
It is not to be feared that today unrecognized drugs are in circulation that are as damaging as Contergan® (thalidomide). Nevertheless, very many drugs have not been adequately researched during pregnancy. But pregnant and breastfeeding women must also be supplied with medicines, because untreated diseases can endanger both mother and child.
Knowledge of drug therapy safety during pregnancy is growing steadily through the documentation and scientific evaluation of drug-exposed pregnancy processes. At the PVZ Embryotox, too, we document the course of pregnancies in which we provide advice and evaluate this data. The clinical evaluation of the drugs also includes the results of scientific studies and reports on drug therapy safety during pregnancy.
The so-called basic risk
It is important to know that child malformations or a miscarriage after drug therapy for the mother do not have to be causally related to the drug.
Around 3-5 out of 100 children show relevant malformations or disorders at birth, most of which have nothing to do with maternal medication. About 15% of all diagnosed pregnancies end in spontaneous abortions. Both represent the so-called basic risk, which also applies to pregnant women without medication.
Basic references for creating the drug and disease pages
Schaefer C, Peters P, Miller RKM. Drugs during pregnancy and lactation, 3rd ed. Elsevier / Academic Press, New York 2015.
Schaefer C, Spielmann H, Vetter K, Weber-Schöndorfer C. Medicines in pregnancy and lactation, 8th edition. Urban & Fischer, Munich 2012.
Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation. 11th ed. Philadelphia: Lippincott Williams & Wilkins; 2017.
Hale TW, Rowe HE. Medications & Mothers' Milk 2019. New York: Springer; 2019.
Individual risk-benefit assessment
Every rational drug therapy is preceded by an individual risk-benefit assessment, in which the possible consequences of the disease are weighed against potential drug risks. Nothing else is necessary in the case of a planned or existing pregnancy. The benefits and potential risks for both the pregnant woman and the child-to-be should be considered. The nature and severity of the disease play a role in the selection of an appropriate treatment, as do the therapeutic alternatives available (including non-drug treatment strategies). Drug therapy during pregnancy should ensure efficient treatment of the underlying disease with the greatest possible safety for the pregnant woman and the child-to-be; both benefit equally from good maternal health during pregnancy.
Individual preferences, goals, and values may differ even more with respect to pregnancy than in many other clinical situations. A participatory decision-making therefore includes the risk-benefit assessment of a therapy for the specific individual case. One hundred percent security, with which risks or adverse effects can be completely excluded from the outset, is hardly to be expected for an effective drug therapy, neither during pregnancy nor in other phases of life. The basic prerequisite for any meaningful drug therapy is therefore a clear treatment indication.
Drug Therapy Safety During Pregnancy
The documentation and scientific evaluation of drug-exposed pregnancy leads to a steady increase in knowledge regarding possible drug risks for the pregnancy and the unborn child. However, randomized, controlled trials of drug therapy safety during pregnancy are problematic for obvious reasons. As a rule, results from animal experiments, in vitro or environmental toxicological studies cannot be directly transferred to the therapeutic use of drugs in humans. Reliable findings, in particular on the risk of congenital malformations and disorders, therefore largely come from methodologically high-quality observational studies that, in addition to the most precisely recorded drug exposure, also include other influencing variables, such as maternal concomitant diseases and other characteristics, in the analysis. In principle, not all potential risks can be ruled out by scientific studies, even with medicinal products that have been well examined for pregnancy. For example, modulating effects on long-term health development are conceivable for drug therapy as well as for an (inadequately treated) underlying maternal disease; there is still a need for research here.
Our range of information
With our Internet portal www.embryotox.de, we want to support the risk-benefit assessment necessary for any drug therapy during pregnancy. For this purpose, the findings from scientific publications and their significance for clinical practice are presented in a manner that is as understandable and structured as possible. We would be happy to advise you individually if you have specific questions or a benefit-risk analysis in specific individual cases (https://www.embryotox.de/beratung/).
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