Abstract
The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies to provide a scientific statement on the safety of glucosamine for patients receiving coumarin anticoagulants. More than 40 case reports have been collected by drug‐monitoring agencies that showed in some patients being prescribed coumarin anticoagulants, especially warfarin, that the International Normalised Ratio (INR) increased after they began taking glucosamine, which indicated an increase in the coagulation time. In most cases the increased INR values were symptomless but in some cases haemorrhage occurred in a variety of organs, and in one case this resulted in a persistent vegetative state. The evidence for an interaction between glucosamine and coumarin anticoagulants is strengthened by the observation that in the majority of cases the INR began to fall to normal values when glucosamine intake was discontinued. There is insufficient information to conclude on a mechanism for an interaction between glucosamine and coumarin anticoagulants. There are also insufficient data in the case reports to derive a dose‐response relationship for glucosamine and to assess the level of risk. The Panel concludes that there is evidence for a risk of interaction between glucosamine and coumarin anticoagulants in some individuals that could lead to an increased INR, and, that this could further lead to haemorrhage. The level of risk cannot be ascertained because of insufficient data.
Keywords: Glucosamine, coumarin anticoagulants, novel food, ingredient
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Scientific Opinion ‐ Statement on the safety of glucosamine for patients receiving coumarin anticoagulants. EFSA Journal 2011;9(12):2473. [8 pp.] doi: 10.2903/j.efsa.2011.2473.
Panel members: Carlo V. Agostoni, Jean‐Louis Bresson, Susan Fairweather‐Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser‐Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen
Correspondence: nda@efsa.europa.eu
Acknowledgement: The Panel wishes to thank for the preparatory work on this scientific opinion the members of the Working Group on Novel Foods: Karl‐Heinz Engel, Ines Golly, Marina Heinonen, Pagona Lagiou, Rosangela Marchelli, Bevan Moseley, Monika Neuhäuser‐Berthold, Annette Pöting, Seppo Salminen, Hendrik Van Loveren and Hans Verhagen.
Adoption date: 25 November 2011
Published date: 8 December 2011
Question number: EFSA‐Q‐2011‐00770
On request from: EFSA
References
- ADRAC/ADRU (Australian Drug Advisory Committee and the Adverse Drug Reaction Unit) , 2008. Interaction between glucosamine and warfarin. Australian Adverse Drug reactions Bulletin 27.
- AFSSA (French Food Safety Agency) , 2008. La glucosamine, Avis de l'Agence française de sécurité sanitaire des aliments sur un project d'arrěté relatif à l'emploi des substances à but nutritionnel ou physiologique et de plantes et préparations de plantes dans la fabrication de compléments alimentaires (Afssa‐Sasine No 2007‐SA‐0231)
- BfR (German Federal Institute for Risk Assessment) , 2009. Food supplements that contain glucosamine can constitute a health risk for patients who take coumarin anticoagulants as blood coagulation inhibitor. BfR Opinion No 004/2010, 14 August 2009.
- EMEA (European Medicines Agency) , 2006. Committee for Medicinal Products for Human Use (CHMP) Opinion Following an Article 29(4)1 Referral for Glucomed and Associated Names (EMEA/405628/2006) (Annex I: List of the Names, Pharmaceuticals, Form, Strength of the Medicinal Products, Route of Administration, Applicant, Marketing, Authorisation Holder in the member states; Annex II: Scientific Conclusions and Grounds for Amendment of the Summary of Product Characteristics, Labelling and Package Leaflet Presented by the EMEA; Annex III: Summary of Product Characteristics, Labelling and Package Leaflet).
- Garcia MG, Pineiro MJI, Alvarez RM, Gonzalez JP, 2004. Interacción farmacológica del sulfato de glucosamina con acenocumarol. Atención Primaria, 33, 162–163. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Health Canada , 2008. Single Ingredient Monographs: Glucosamine. Available from: www.hc‐sc.gc.ca/dhp‐mps/prodnatur/applications/licen‐prod/monograph/mono_glucosamine‐eng.php
- Knudson and Sokol, 2008. Potential glucosamine‐warfarin interaction resulting in increased international normalized ratio: case report and review of the literature and MedWatch database. Pharmacotherapy, 28, 540–8. [DOI] [PubMed] [Google Scholar]
- MHRA (Medicines and Healthcare products Regulatory Agency) , 2007. Cases of warfarin/glucosamine interaction reported in the May 2006 Current Problem in Pharmacovigilance series – Freedom of information disclosure. (06/330 request)
- Wysowski DK, Nourjah P and Swartz L, 2007. Bleeding complications with warfarin use. A prevalent adverse effect resulting in regulatory action. Archives of Internal Medicine, 167, 1414–1419. [DOI] [PubMed] [Google Scholar]
- Yue Q‐Y, Strandell J and Myrberg O, 2006. Concomitant use of glucosamine may potentiate the effect of warfarin. Poster, ISoP 2006.