Number Significance of over-the-counter (OTC) herbal medicinal products (HMP): ATC code R

2021 ◽  
Author(s):  
Ivan Lalovski ◽  
Ivan Svinyarov ◽  
Anely Nedelcheva
2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Maryam Modarai ◽  
Elisabete Silva ◽  
Andy Suter ◽  
Michael Heinrich ◽  
Andreas Kortenkamp

A major safety concern with the use of herbal medicinal products (HMP) is their interactions with conventional medicines, which are often mediated via the cytochrome P450 (CYP) system. Echinacea is a widely used over-the-counter HMP, with proven immunomodulatory properties. Its increasing use makes research into its safety an urgent concern. Previously, we showed that Echinacea extracts and its alkylamides (thought to be important for Echinacea's immunomodulatory activity) mildly inhibit the enzymatic activity of the main drug metabolising CYP isoforms, but to this date, there is insufficient work on its ability to alter CYP expression levels. We now report for the first time the effect of a commercial Echinacea extract (Echinaforce) and four Echinacea alkylamides on the transcription of the major drug metabolizing enzyme CYP3A4. HepG2 cells were exposed for 96 h to clinically relevant concentrations of Echinaforce (22, 11.6 and 1.16 μg mL−1) or the alkylamides (1.62 and 44 nM). CYP3A4 mRNA levels were quantified using real-time reverse transcription polymerase chain reaction (RT-PCR). Neither Echinaforce nor the alkylamides produced any significant changes in the steady-state CYP3A4 mRNA levels, under these conditions. In contrast, treatment with 50 μM rifampicin resulted in a 3.8-fold up-regulation over the vehicle control. We conclude that Echinaforce is unlikely to affect CYP3A4 transcriptional levels, even at concentrations which can inhibit the enzymatic activity of CYP3A4. Overall, our data provides further evidence for the lack of interactions between Echinacea and conventional drugs.


HortScience ◽  
2006 ◽  
Vol 41 (2) ◽  
pp. 292-295 ◽  
Author(s):  
James W. Rushing

The production, handling, processing and marketing of over-the-counter medicinal products manufactured from plants is virtually unregulated. This can include dietary supplements, functional foods and nutraceuticals, any of which may contain botanical constituents. Of particular concern is the possible presence of human pathogens in products offered at retail. A review of literature is presented. Options for sterilizing herbal medicinal products, including fumigation, irradiation and heat treatments, are presented. Experiences of the spice industry are discussed as they relate to the development of similar protocols for herbal medicines. Methods used to ensure microbiological safety must be evaluated for their effect on the medicinally active constituents in the plant material. Very little data of this nature are available. Avenues for future research are proposed.


2015 ◽  
Vol 10 (1) ◽  
pp. 1934578X1501000 ◽  
Author(s):  
Anna Rita Bilia

Botanical products marketed in Europe are diverse, classified as herbal medicinal products, dietary supplements, cosmetics, foods and beverages depending on the relevant applicable legislation. Many factors are taken into account in the classification of a botanical product (e.g. intended use, labeling, preparations and dosages) according to how it is placed on the market. Herbal medicinal products (HMPs) can only be sold in pharmacies, under the supervision of a pharmacist, and are marketed after full or simplified registration procedures according to their classification, i.e. as over-the-counter drugs (OTC) available without special restrictions and prescription only medicine (POM), which must be prescribed by a licensed medical practitioner. The dietary supplement segment is also sold in the market in dose form (such as capsules, tablets, ampoules of liquids, drops etc) and represents 15-20% of the botanical market at the European level with high variability among each country (i.e. in Italy it reaches up to 80%). In many cases the distinction between medicinal products and food supplements has generated borderline botanical-sourced products, which generally produce confusion and mislead the consumers. As a consequence, there is an urgent need of consumer education and in addition to collect comprehensive data and make this database systematically available to herbalists, nutritionists and medical specialists for a proper classification and harmonization of the use of botanical ingredients, and, as consequence, a correct use of these products.


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