Warnings & Interactions of Herbs

, December 2, 2015 in Therapeutics

You will notice that our single herbal products have numbers & letters assigned to them corresponding to Warnings & Interactions. This paper explains what each of the numbers and/or letters implies.

SAFETY CLASSES
CLASS 1
Herbs that can be safely consumed when used appropriately.
• History of safe traditional use
• No case reports of significant adverse events with high probability of causality
• No identified concerns for use during pregnancy or lactation
• No innately toxic constituents
• Toxicity associated with excessive use is not a basis for exclusion from this class
• Minor or self-limiting side effects are not bases for exclusion from this class

CLASS 2
Herbs for which the following use restrictions apply, unless otherwise directed by an expert qualified in the use of the described substance:

2a: for external use only
• Toxicity demonstrated with crude preparation taken orally at traditional dose
• Adverse event data in humans with probability of causality of toxicity (eg. hepatotoxicity, nephrotoxicity, neurotoxicity) associated with oral use

2b: Not to be used during pregnancy
• Traditional use contraindicates
• Traditional use as an abortifacient or uterine stimulant
• Relevant adverse even data in humans exist and have probability of causality
• Data in animals suggesting teratogenicity or other adverse effects on the fetus or mother, with reasonable application to humans
• For plants with common food uses, standard dose is in excess of typical food amounts

2c: Not to be used while nursing
• Traditional use contraindicates
• Relevant adverse event data in humans exists and has probability of causality
• Potential hepatotoxicity or neurotoxicity
• Bioavailability of constituents of concern in breast milk has been demonstrated

2d: Other specific use restrictions as noted
• Information exists that use may be unsafe for specific populations
• Dosage level outside of a standard range known to cause adverse effects

CLASS 3
Herbs to be used only under the supervision of a qualified expert. The following labelling is recommended for Class 3 herbs: “To be used only under the supervision of an expert qualified in the appropriate use of this substance. “ Labelling must include proper use information:
dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of the substance.
• Narrow therapeutic range
• Identified safety concerns in many populations

INTERACTION CLASSES

CLASS A
Herbs for which no clinically relevant interactions are expected.
• No case reports of suspected interactions with probability of causality
• No clinically relevant interactions in human pharmacological studies, if any,

CLASS B
Herbs for which clinically relevant interactions are biologically plausible
• Human or animal pharmacological study data suggest potential for clinically relevant interaction.
• Multiple case reports have suggested a potential interaction concern.
• Cell culture or biochemical assays establish a basis for biologically plausible mechanism of interaction.

CLASS C
Herbs for which clinically relevant interactions are know to occur
• Human pharmacological study has demonstrated interaction with a specific drug or supplement.
• Human pharmacological study has demonstrated clinically relevant effects on drug metabolizing enzymes or drug transporter proteins.
• Case reports of suspected interactions have a probability of causality.

all of our safety information is from:
The Botanical Safety Handbook
Second Edition
Edited by: Zoë Gardner, Michael McGuffin
Expert Advisory Council: Roy Upton, Soaring Bear, David Winston, Daniel Gagnon, Aviva Romm, Tieraona Low Dog, Mary Hardy, Lyle Craker

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