Gravbase and lactbase are decision support databases that give concise evidence based information on the safety of different drugs during pregnancy and lactation in a user friendly format. In addition to clinically used drugs, information exists also on vitamins, illicit substances of abuse and commonly used substances as caffeine, nicotine etc. The goal of gravbase and lactbase is to provide the user with an up-to-date information on the safety of various substances during pregnancy and lactation, with powerful search methods that enable quick help for decision making when prescribing or dispensing medications to women. The databases can easily be integrated into various medical portals and electronic patient record systems to give automated warnings and recommendation on drug use during pregnancy and lactation. Also, patient-oriented versions on gravbase and lactbase are available.
All information has been produced according to standard operation procedures including both published medical information and the manufacturer provided information approved by EMA and FDA, as well as information from national registers. All texts are produced and approved by medical doctors specialised in clinical pharmacology and therapeutics. Heli Malm, MD, PhD, one of the leading European experts in teratology is working as a scientific consultant in the development and maintenance of gravbase and lactbase. Gravbase and lactbase provide the user with holistic clinical advice including recommendations on laboratory and ultrasound monitoring as well e.g. on folic acid substitution.
Gravbase and lactbase analyse the safety of various drugs and substances by dividing them into 4 categories according to the level of documentation available and a risk analysis made on the basis of the documentation (see Classification). Both databases give a short, clinically oriented, RECOMMENDATION in end-user native language to enable a quick review of the safety information for clinicians/pharmacists. Gravbase and lactbase also enable easy comparison of different substances within a therapeutic drug group, to ease the choice of most appropriate medication for various medical conditions during pregnancy and lactation. The BACKGROUND part gives a concise review of the published and manufacturer provided information on the safety of each substance during pregnancy and lactation. The REFERENCES are PubMed-linked to enable a quick access to the original publications. Gravbase and lactbase are updated four times a year. Copyright and the trademarks of gravbase and lactbase belong to Medbase Ltd.
|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 1. trimester. Also, there is no evidence of a risk after exposure during 2. or 3. trimester.
|There is only a limited amount information on the use during pregnancy and there are no controlled studies in pregnant women. Animal teratology or limited human data indicate no evidence of increased risk of malformations or direct or indirect fetal adverse effects.
|There is only a limited amount information on the use during pregnancy and there are no controlled studies in pregnant women or the information is conflicting. Animal teratology data indicate increased risk of malformations or direct or indirect fetal adverse effects or animal teratology data is missing.
|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.
|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 overweigh the risk.
|Drug is not excreted into breast milk in significant amounts or there is evidence that indicates lack of adverse effects in the infant, when the mother uses the drug in recommended therapeutic doses.
|There are no studies on the excretion of the drug into breast milk. There is only a limited amount or no data on the safety during breastfeeding.
|The evidence suggests that a clinically relevant amount of the maternal drug dose is excreted into breast milk. Therapeutic maternal drug doses during breast feeding pose an increased risk for infant adverse effects. The decision on breast-feeding needs to made individually considering the potential benefits in relation to the potential risk.
|Breast-feeding is contraindicated while using the drug. The use of the drug during breast feeding may cause severe adverse effects on the suckling infant.