Abstract
BackgroundSt. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA.MethodsEight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings.ResultsOf the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0–8) for 23.9% completeness.ConclusionThe vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of counseling by HCPs and health store clerks. HCPs and consumers may benefit if the FDA re-examined labeling requirements for dietary supplements.
Highlights
IntroductionThere are documented interactions between St. John's wort (SJW) and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives
It has been postulated that the drug interactions observed with the co-administration of St. John's wort (SJW) and prescription medication such as those described above are mediated by different mechanisms
The percentages of products with label information including the respective safety issues were as follows: SJW-HIV medications (8.1%), SJW-immunosupressants (5.4%), SJW-oral contraceptives (OCPs) (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult healthcare professionals (HCPs) (87.8%)
Summary
There are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. John's wort (Hypericum perforatum), used most commonly for depression, is one of the top selling and best researched herbs used in the USA [1,2,3] It is popular in Canada and many countries in Europe – including Germany, where it is used more frequently than selective serotonin reuptake inhibitors (SSRIs) [4,5]. It has been postulated that the drug interactions observed with the co-administration of SJW and prescription medication such as those described above are mediated by different mechanisms. Use of SJW has been associated with reversible photosensitivity causing erythematous skin lesions after sun exposure [10]
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