scholarly journals Interactions between Natural Health Products and Oral Anticoagulants: Spontaneous Reports in the Italian Surveillance System of Natural Health Products

2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
Angelica Paoletti ◽  
Eugenia Gallo ◽  
Silvia Benemei ◽  
Michele Vietri ◽  
Francesco Lapi ◽  
...  

Introduction. The safety of vitamin K antagonists (VKA) use can be compromised by many popular herbal supplements taken by individuals. The literature reports that 30% of warfarin-treated patients self-medicates with herbs. Possible interactions represent an health risk. We aimed to identify all herbs-oral anticoagulants interactions collected in the Italian database of suspected adverse reactions to “natural health” products.Methods. The Italian database of spontaneous reports of suspected adverse reactions to natural products was analyzed to address herb-VKAs interactions.Results. From 2002 to 2009, we identified 12 reports with 7 cases of INR reduction in patients treated with warfarin (n=3) and acenocoumarol (n=4), and 5 cases of INR increase (all warfarin associated). It was reported 8 different herbal products as possibly interacting.Discussion. Our study confirms the risk of interactions, highlighting the difficulty to characterize them and their mechanisms and, finally, prevent their onset. The reported data underline the urgent need of healthcare providers being aware of the possible interaction between natural products and VKA, also because of the critical clinical conditions affecting patients. This is the first step to have the best approach to understand possible INR alterations linked to herb-VKA interaction and to rightly educate patients in treatment with VKA.

Drug Safety ◽  
2008 ◽  
Vol 31 (5) ◽  
pp. 419-423 ◽  
Author(s):  
Francesca Menniti-Ippolito ◽  
Gabriela Mazzanti ◽  
Annabella Vitalone ◽  
Fabio Firenzuoli ◽  
Carmela Santuccio

2008 ◽  
Vol 17 (6) ◽  
pp. 626-635 ◽  
Author(s):  
Francesca Menniti-Ippolito ◽  
Gabriela Mazzanti ◽  
Carmela Santuccio ◽  
Paola Angela Moro ◽  
Gioacchino Calapai ◽  
...  

Author(s):  
Brian C. Foster ◽  
J. Thor Arnason ◽  
Colin J. Briggs

Botanicals such as herbal products (HPs) and nutraceuticals (NCs) are often regarded as low risk because of their long history of human use. Anecdotal and literature reports of adverse drug events (ADEs) and clinical studies with HPs are increasing, but many of the reports are incomplete and contradictory. These reports need to identify confounding factors and explain contradictory findings if they are to help health care professionals or patients understand what risks are involved. HPs are complex botanicals, not single-active ingredient (SAI) products. Studies can be confounded by different manufacturing processes and formulations, including cosmetics and food supplements; environment; chemotypes; misidentification or adulteration; and factors associated with the patient or user population such as use, total drug load, and genetics. Future studies need to be conducted with characterized product that includes all commercially available related products. Clinical trials should be relevant to the user population and take into account the confounding factors that may influence the interpretation of the findings.


2017 ◽  
Vol 30 (6) ◽  
pp. 590-592 ◽  
Author(s):  
David F. Blackburn ◽  
Munpreet Gill ◽  
Ed Krol ◽  
Jeff Taylor

The allure of natural products has captivated humans for centuries. Although they can be compatible with evidence-based care, attitudes surrounding natural products can seem almost mystical and may even be accompanied by contempt toward Western medicine. Considering the high volumes of natural products sold in community pharmacies, pharmacists can inject balanced information to minimize the mysticism and help patients make informed decisions. The aim of this article is to argue for standardized guidelines pertaining to the management of natural products in community pharmacy practice.


2008 ◽  
Vol 66 (4) ◽  
pp. 572-574 ◽  
Author(s):  
Francesco Lapi ◽  
Eugenia Gallo ◽  
Sara Bernasconi ◽  
Michele Vietri ◽  
Francesca Menniti-Ippolito ◽  
...  

2007 ◽  
Vol 85 (11) ◽  
pp. 1099-1107 ◽  
Author(s):  
B. Chauhan ◽  
C. Yu ◽  
A. Krantis ◽  
I. Scott ◽  
J. T. Arnason ◽  
...  

Some natural health products (NHPs) affect drug metabolism enzymes and transport proteins, potentially affecting the safety and efficacy of the drug or other NHPs. This study was undertaken to characterize the effect of uva-ursi ( Arctostaphylos uva-ursi ) on cytochrome P450 isozyme (3A4, 3A5, 3A7, 2C19, and 19)-mediated metabolism and P-glycoprotein (P-gp) transport. Three bulk and 2 capsulated uva-ursi samples were obtained from commercial outlets. The capsules were batched, and herbal samples were ground to a common consistency. Aqueous and methanol extracts were freshly prepared. Cytochrome P450 isozyme-mediated metabolism was determined by using in vitro bioassays. P-gp transport function was determined by using a rhodamine 123 (Rh123) uptake test in human (THP-1) monocytes and human Caco-2 cells. All products were analyzed by HPLC for arbutin, gallic acid, myricitrin, and isoquercetin. A large variation was observed in the biomarkers found between the bulk and capsulated samples. Our data indicate that both the aqueous and methanol extracts of all 5 uva-ursi products showed high cytochrome P450 isozyme inhibition, with the exception of the methanol extracts against cytochromes P3A4 and P19, which had low to moderate activity. The aqueous extracts of uva-ursi showed an inhibitory effect on Rh123 efflux by P-gp at 1 h and an inductive effect at 18 h for both cell lines. Our results show that the uva-ursi herbal products tested here have pharmacological properties, including the potential capacity to affect drug safety and efficacy. Further studies are warranted against a wider range of cytochrome P450 isozymes and to determine whether these effects are clinically significant.


Author(s):  
Nehad J. Ahmed ◽  
Ahmed A. Albassam ◽  
Mshari Alonazi ◽  
Maged S. Abdel-Kader

Introduction: Complementary and alternative medicine (CAM) is flourishing very fast and the usage of CAM in health care is quickly evolving. The behavior and attitude of the patients towards herbal medicines represents an important concern for policy makers and for regulators. Objective: The aim of this study is to evaluate the pattern of natural products use among the public and the Attitudes towards natural health products in Al-kharj Methodology: This is a cross-sectional study design. A questionnaire was prepared using Google drive tool and used to evaluate the pattern of natural products use among the public and the attitudes towards natural health products in Al-kharj governorate. The survey was filled by 442 participants. Results: Most respondents used a natural health product in the past (only 319 of 442 have been used natural product), the most used products were Vitamins/Minerals (85.57%). Additionally, about 50 % of the respondents agreed that the natural health products are safe because they are made from natural ingredients. The majority of the respondents reported that there isn't enough information on natural health product labels to help them understand the Products. The majority reported that the family and friends were recommended and provided them with the information regarding the use of the natural health product (71.78%). Conclusion: The present study showed that the use of herbal medicine is a common practice. The legislation is recommended to arrange the using of natural health products. The study results would surely require an active role for the Ministry of Health and Saudi Food and Drug Authority (SFDA) to insure enough information regard the risks and benefits of NHPs.


2007 ◽  
Vol 85 (9) ◽  
pp. 952-955 ◽  
Author(s):  
Mano Murty

Postmarket surveillance, particularly adverse reactions (ARs), forms an integral part of the ongoing safety evaluation for natural health products (NHPs). ARs can be related to many factors, including inherent toxicity, misuse, hypersensitivity, NHP–drug interactions, or product quality. High consumer use and limited safety and efficacy data from human clinical trials for many NHPs present a challenge to consumers, healthcare practitioners, and federal regulators. Canada’s Natural Health Products Regulations mandate NHPs to be licensed. As the currently available unauthorized NHPs are being brought into compliance in Canada, the transition has produced some challenges, requiring ongoing public communication and education to promote the safe use of NHPs. This article will highlight Health Canada’s key postmarket initiatives in strengthening the regulation of NHPs.


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