Information on drug treatment in
pregnancy and lactation
Up to 81% of pregnant women use at least one medication during pregnancy (1). Chronic diseases, such as epilepsy, require treatment throughout pregnancy. Drugs may cause congenital malformations or long-term developmental adverse effects on the infant. Accidental drug exposures can provoke worry, often unnecessarily (1,2). Further, drug metabolism changes during pregnancy, and dose adjustments may be needed (3).
Breastfeeding can have many benefits, and in many cases tight restrictions on breastfeeding due to maternal drug treatment may not be justified (4).
Summaries of product characteristics are often restrictive, and clinically feasible advice for patients who are pregnant, planning to become pregnant, or breastfeeding may not be available (5). In addition, clinical trials exclude pregnant and breastfeeding women; therefore, data accumulates through registries, small observational studies and accidental exposures.
81%
“Up to 81% of pregnant women use at least one medication during pregnancy.”
Clinical solution
Gravbase and Lactbase offer the latest evidence-based information on the safety of drug treatment during pregnancy and lactation in a concise, user-friendly format. In addition to clinically used drugs, these databases provide recommendations on vitamins, illicit and recreational drugs as well as commonly used substances such as alcohol, caffeine and nicotine.
Key characteristics
of Gravbase and Lactbase:
- Comprehensive drug-specific risk assessment with mechanism of action, pharmacokinetics, preclinical and clinical data
- Recommendations on drugs, vitamins, illicit and recreational drugs as well as alcohol, caffeine and nicotine
- Clear comparisons of risks between different substances within a therapeutic drug group to aid users in choosing the most appropriate medication
- Drug specific recommendations on wash-out periods, therapeutic drug monitoring, dose adjustments, vitamin substitutions, and special level fetal diagnostics when needed
- Fully referenced medical and scientific background information with links
- Separate versions available for medical workers and patients, with less technical language used in the patient versions
Classification methodology
Gravbase and Lactbase classify the safety of various drugs and substances into four categories based on comprehensive risk assessment using all available relevant background information, including mechanism of action, pharmacokinetics and preclinical and clinical data.
Classification and recommendations in Gravbase
| D | There is a strong suspicion or direct evidence of malformations or direct or indirect human fetal adverse effects. The drug is usually contraindicated during pregnancy, but in some cases the benefits may outweigh the risk. |
| C2 | Animal teratology or limited human data indicate no evidence of increased risk of malformations, but late pregnancy use may pose a risk of adverse effects during the neonatal period or during childhood. |
| C1 | There is only a limited amount of information on use during pregnancy. No controlled studies have been conducted with pregnant women, or information is conflicting. Animal teratology data indicate increased risk of malformations or direct or indirect fetal adverse effects, or animal teratology data is missing. |
| B | There is only a limited amount information on use during pregnancy. No controlled studies have been conducted with pregnant women. Animal teratology or limited human data indicate no evidence of increased risk of malformations or direct or indirect fetal adverse effects. |
| A | Controlled studies or large patient materials fail to demonstrate an increased risk for malformations or for direct or indirect fetal adverse effects after exposure during the first trimester. Likewise, there is no evidence of risk after exposure during the second or third trimester. |
Classification and recommendations in Lactbase
| D | Breastfeeding is contraindicated while using the drug. The use of the drug during breastfeeding may cause severe adverse effects on the suckling infant. |
| C | The evidence suggests that a clinically relevant amount of the maternal drug dose is excreted into breast milk. Therapeutic maternal drug doses during breastfeeding pose an increased risk for infant adverse effects. The decision on breastfeeding should be made individually, considering the potential benefits in relation to the potential risk. |
| B | There are no studies on the excretion of the drug into breast milk. There is only a limited amount or no data on use during breastfeeding. |
| A | The drug is not excreted into breast milk in significant amounts, or there is evidence that indicates a lack of adverse effects in the infant when the breastfeeding mother uses the drug in recommended therapeutic doses. |
Languages and local drug registries
Medbase content is available in English and more than ten additional languages. To further improve local usability, we accommodate national, local and customer-specific drug product registries, allowing access to information using local drug product names and IDs.
Integration with local electronic health record (EHR) systems is straightforward, enabling smooth and efficient use of regularly updated Medbase drug information across various countries.
Latest information from trusted sources
All information is based on scientific evidence. We refer to published, peer-reviewed research articles from PubMed, a reliable source of biomedical and life sciences literature, as well as regulatory authority approved documents, such as the Summaries of Product Characteristics (SPC) of drugs. To ensure coherent and clinically useful guidance, we regularly consult the national Teratology Information Service at Helsinki University Hospital, one of the largest hospitals in Europe.
Medbase Knowledgebase is continuously updated to ensure the inclusion of the latest information.
Supporting informed decisions for safe drug use
Enhanced patient safety
Holistic approach to patient’s pharmacotherapy enabling individualised drug treatment.
100% Evidence-based
Fully referenced information with transparency to original sources: documents approved by regulatory authorities and peer-reviewed literature.
Clinical relevance
We provide comprehensive and concise information for safe use of drugs, accessible from one single source.
Digitalised doctor consultation
Designed to support busy clinical practice for safe use of drugs. All information is created and validated by physicians specialised in clinical pharmacology.
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- Lupattelli A, Spigset O, Twigg MJ, Zagorodnikova K, Mårdby AC, Moretti ME, Drozd M, Panchaud A, Hämeen-Anttila K, Rieutord A, Gjergja Juraski R, Odalovic M, Kennedy D, Rudolf G, Juch H, Passier A, Björnsdóttir I, Nordeng H. Medication use in pregnancy: a cross-sectional, multinational web-based study. BMJ Open. 2014 Feb 17;4(2):e004365. doi: 10.1136/bmjopen-2013-004365. PMID: 24534260; PMCID: PMC3927801.
- Mulder B, Bijlsma MJ, Schuiling-Veninga CC, Morssink LP, van Puijenbroek E, Aarnoudse JG, Hak E, de Vries TW. Risks versus benefits of medication use during pregnancy: what do women perceive? Patient Prefer Adherence. 2017 Dec 20;12:1-8. doi: 10.2147/PPA.S146091. PMID: 29302186; PMCID: PMC5741981.
- Mesraoua B, Brigo F, Lattanzi S, Perucca E, Ali M, Asadi-Pooya AA. Safe delivery, perinatal outcomes and breastfeeding in women with epilepsy. Epilepsy Behav. 2024 May 16;156:109827. doi: 10.1016/j.yebeh.2024.109827. Epub ahead of print. PMID: 38759429.
- World Health Organization. Exclusive breastfeeding for optimal growth, development and health of infants. Intervention, updated 9 August 2023.
- Sinclair SM, Miller RK, Chambers C, Cooper EM. Medication Safety During Pregnancy: Improving Evidence-Based Practice. J Midwifery Womens Health. 2016 Jan-Feb;61(1):52-67. doi: 10.1111/jmwh.12358. Epub 2016 Jan 13. PMID: 26771055.