Which resource or what is the most reliable reference/website/textbook to check when looking for the safety of medications during pregnancy?
You might find this article of interest:
Tonnes et al. Safety profile of medication used during pregnancy: results of a multinational European study. Pharmacoepidemiol Drug Saf. 2017 Jul; 26(7):802–811. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5518438/
Published online 2017 Apr 27. doi: 10.1002/pds.4213
PMCID: PMC5518438
PMID: 28449197
(Poisons Information Officer) In the absence of information on the medicines information sheet, we often use a text by Briggs et al. 2002 A reference guide to fetal and neonatal risk: Drugs in Lactation and Pregnancy: Sixth Edition. Another text is by Hale, 2008, Medications and Mothers' Milk: Thirteenth Edition
Essentially the best resources to find the Full Prescribing Information (SPC) at launch of product is the fda using the Trrade or generic name; these are updated if changes occur during marketing to patients. If it is not marketed in the USA the next port of call is the EMA (the equivalent of the FDA for the EU) where one should be able to find the same information.
The PIL or prescribing information leaflet included in the packaging and scripts are in my view useless!
In addition each company that markets a drug should also hold the same information on their databases, although to obtain this sometimes one has to say that you are from the medical profession, not the general public, to access the information.
Clearly information is becoming more detailed with time and this is accessibility to the information is changing to the volume and being broken down by section. In this case one would need to look under use in specific populations, also on the SPCs.
Usually these are reasonably easy to find by google searching but may be more difficult to the amount of confusing data now available. However, the FDA and EMA are the reliable sources.
In any event, any general practitioner would advise against any additional medication, apart from the absolutely essential e.g. insulin, during the first 3 months fo pregnancy and normally for the hole duration.
Many if most drugs are absorbed across the placenta, especially important during the first 3 months of gestation. ALSO the vast majority, if not all unless specifically for pregnant woman, will not have been tested in patients prior to marketing. There is therefore no evidence available until after marketing when data are reported during the first 5 years of marketing as adverse events and then if considered serious enough throughout the life of the product by the marketing company and FDA and EMA.
In conclusion, whilst information is available elsewhere, the normal advice these days is to avoid taking anything if at all possible during pregnancy, including morning sickness however severe.
Another drug with similar effects to thalidomide may already be on the market, or in the future. Nothing can change this fact since it would still not have been picked up today, unless taken during the first 3 months of pregnancy after marketing, if taken when it was already advised against.
Hope that this helps. If the information one finds is too technical the ask your doctor.
I'll add this to the resources already mentioned here http://www.safefetus.com/
My favourite reference book is "Drugs during pregnancy and Lactation" by Christof Schaefer, Paul Peters & Richard K. Miller, use latest edition (actual 3rd as of 2015). Otherwise use the drug's summary of product characteristics adjusted to FDA's new Labelling Rules. And consult the national Teratology Information Service such as UK Teratology Information Service (UKTIS) www.uktis.org/
Hope that helps a bit
Geertje, reproductive toxicologist
Hello Mostafa,
As it was mentioned above, the book entitled "Drugs in Pregnancy and Lactation" by Gerald G. BriggsRoger K. FreemanCraig V. TowersAlicia B. Forinash is one of the best resources for physicians and pharmacists in this regard. This book is evidence based, practical, and educational, and published by Lippincott Williams & Wilkins.
Hello Mostafa Elsersy,
As many of the above researchers mentioned there are certain governing bodies, websites, textbooks etc., However, I just want to make your life easier with my answer. (by hoping it would be useful)
As information and research about the risks of medications, vaccines, chemicals or diseases during a woman’s pregnancy are constantly changing and can be confusing, or misrepresented, the Harvard Medical School (if I'm not wrong) has developed an App called "MotherToBaby"
It is designed to provide evidence-based information to pregnant and breastfeeding women. There is Information on a broad range of medications, some herbal remedies, maternal illness, infections and vaccines, alcohol and other substances, occupational exposures, and other exposures (including things like lead, hair dye).
MotherToBaby is a suggested resource by many agencies including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration’s (FDA) Office of Women’s Health.
I hope this helps.
As a family doctor, I prefer to use Briggs' book and access it online. http://solution.lww.com/briggsdrugsinpregnancy#tab_168614
I recommend Briggs's Drug Use in Pregnancy and Lactation. Additional resource can be Reprorisk from Micromedex.
Brigg's and an additionally a German Service from Berlin Charité called Embryotox https://www.embryotox.de
But German wouldn't probably be helpful to you. But they are always up to date.
1. Food and Drug Administration- FDA USA Guide lines
2. UK Drugs Formulation Guide lines
Regards
Dear Marwah Firas Abdullah Al-Rawe
I think most of the leaflets will be in safe side e..g no data is available on use during pregnancy
A drug is assigned a pregancy category before being introduced in the market. It is available on the label of the drug. Also, you can download the label of the drug/detailed information from US-FDA/European-EMA, Canadian-Health Canada, Australian-TGA websites, the links of which are provided below:
-https://www.accessdata.fda.gov/scripts/cder/daf/
-https://www.ema.europa.eu/en/medicines
-https://hpr-rps.hres.ca/reg-content/summary-basis-decision.php
-https://www.tga.gov.au/ws-auspar-index
For a general understanding, you can read my article: "Drugs contraindicated during pregnancy", which is available on ResearchGate, link is provided below.
-Article Drugs contraindicated during pregnancy
I find UpToDate reasonably dependable, it also has access to detailed drug information.
In Germany, we have an open access database : www.embryotox.de which is on a very high standard and available for the pregnant women theirselves too.
You can see some english information here :
Article [Drug safety in pregnancy - the Embryotox project.]
but the data base is in german ..
I usually use the drug information leaflet first followed by, BNF since has a category dedicated to drug use in pregnancy. In other cases I will use Drugs.com or FDA /UK links dedicated to drug information
Update -has access to detailed drug information and also use US Food and Drug Administration guidelines
medicines in pregnancy
Food and Drug Administration- FDA USA Guide lines
Williams obstetrics book
Internal and surgical diseases during pregnancy.
Updating information on medications.
Browse the latest research on medications During pregnancy.
as a nurse and lactation consultant, I rely on Medication and Mother's Milk by Thomas Hale, PhD and Hilary Rowe, PharmaD. While not specific to pregnacy, it is considered the authority on medications and breastfeeding. there is also a website, Infant Risk Center. I also use LactMed, the National Library of US Medicine's database.
Food Drug Administration USA ( USA), Harrison's principles of internal medicine
Used standard methods to investigate the effect of drug on female reproductive system and its teratogenic effects
Article EMBRYOTOXICITY OF FLUOROQUINOLONES IN RATS
Article Embryotoxicity of norfloxacin in mice
https://www.hindawi.com/journals/ecam/2019/3807207/ref/
for herbal products:
Botanical Safety Handbook
http://www.ahpa.org/Resources/BotanicalSafetyHandbook.aspx
Food Drug Administration USA ( USA), Harrison's principles of internal medicine( USA)
Use British national formulary (BNF) it's more reliable for pregnancy medication
…
OTIS, now called MotherToBaby www.mothertobaby.org
ENTIS www.entis-org.eu for providers working in Europe
The older pregnancy categories are misleading and the US has moved toward new formatting: Article The New Pregnancy and Lactation Labeling Rule
Use British national formulary (BNF) it's more reliable for pregnancy medication
Drugs in Pregnancy and Lactation, Tenth Edition by Gerald G. Briggs
Food Drug Administration USA ( USA), Harrison's principles of internal medicine
www.lecrat.fr
it is a french site that I used to check to look for the safety of medications during pregnancy.
I recommend it
MotherToBaby is a suggested resource by many agencies including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration's (FDA) Office of Women's Health.
drugs in pregnancy and lactation, or the App LacMed.
http://www.ahpa.org/Resources/BotanicalSafetyHandbook.aspx
Medicine use during Pregnancy or Breastfeeding
Food and Drug Administration's (FDA)
Williams Obstetrics
Pharmacology Books
Medicine Guidelines During Pregnancy
Medicine use during Pregnancy or Breastfeeding
https://www.cdc.gov/pregnancy/meds/treatingfortwo/treatment-guidelines.html
Guidelines and Recommendations for Treating and Managing Health Conditions during Pregnancy
Medicine Guidelines During Pregnancy
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