Possible Adverse Reactions to Herbal Products: A Study with Individuals Who Resort To Popular Medicine in the City of Diadema, SP, Brazil

Abstract

The present study aimed to investigate the occurrence of adverse reactions (ADRs) related to herbal products (HPs), which are purchased over-the-counter for self-treatment, reported by 100 users. Samples of the HPs related to those ADRs were purchased for their pharmacobotanical identification. The ADRs reported were evaluated based on specialized literature and were analyzed according to causality into probable (PR), possible (PO), unrelated (UR) or unclassifiable (UC); according to expectance into unexpected adverse reaction (UNEX) and expected adverse reaction (EX); seriousness into serious adverse event or reaction (S) and non-serious (NS); and severity into mild (MI), moderate (MO) and severe (SE). Among 100 interviews, five complaints of ADRs were reported in relation to HPs: Senna alexandrina, with a report of cramps (PR; MI; EX; NS); Camellia sinensis, associated with tachycardia (PO; MI; EX; NS); Bauhinia sp., a strong allergic reaction that led to hospitalization (UC; MO; UNEX; S); Picrasma crenata, with several symptoms and hospitalization (UR; MO; UNEX; S); and 21-herb tea, related to an allergic reaction (UC; MI; EX; NS). The strategies used in this study allowed us to carry out an analysis of ADRs attributed to HPs. This analysis could serve as a model in the study of similar cases.

Development of Instrument to Report and Assess Causality of Adverse Events Related to Herbal Medicines

“…A pharmacovigilance system of herbal medicines also started in the same year by the publication of a notification form of adverse reactions related to herbal medicines (RAMP) by the institution. Therefore, the instrument form developed in this study will allow identification of other potential adverse events associated with the use of these products, such as handling and packaging [14,15] , improper storage and identification [15] , serious adverse reactions [38] , and medication errors [13] . This instrument is suitable for identification of adverse events related to herbal medicines, since it improves upon the previously available forms by ANVISA and CEBRID and expands the possibility of identification of events other than adverse reaction.…”

A Cases of Near-fatal Anaphylaxis: Parsley “Over-use” as an Herbal Remedy

“…When herbal products are mentioned, it is usually in the form of tablets or capsules, or uncommon plants that are not included in routine consumption ( 1 ). However, we often consume plants in our daily lives that are in the class of weeds but are referred to as vegetables, as they are not considered herbal products because they are consumed as food.…”

“…However, it was not possible, due to the patient’s misinterpretation. Moreover, the symptomatology was perceived in a completely different way, as “seeing the benefit”, and the patient approached anaphylaxis, step by step ( 1 , 3 , 6 ).…”

“…Some studies have stated that herbal products may be harmful to patients with allergies. Indeed, allergic reactions, ranging from oral allergy syndrome to severe anaphylactic attacks, have been seen, especially in people with weed pollen allergies ( 1 , 2 ). In this paper, we present the case of a woman who experienced near-fatal anaphylaxis to parsley.…”

Herbal Medicines for the Treatment of Functional and Inflammatory Bowel Disorders

“…[64][65][66][67] These adverse events range from allergic reactions, [68][69] gastrointestinal side effects, 70 acute hepatitis 71 or other serious adverse events including Stevens-Johnson syndrome, anaphylactic shock and exfoliative dermatitis including reactions that may necessitate hospital admissions. 72 There have also been reports of hepatotoxicity. A critical review by Teschke et al 73 revealed that many different herbs and herbal products have been implicated to cause toxic liver disease, however significant issues with the quality of these studies renders it difficult to determine whether the herbs were actually causal.…”