title: Clinically relevant safety issues associated with St. John's wort product labels.
abstract: BACKGROUND
  St. 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.
  
  
  METHODS
  Eight 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.
  
  
  RESULTS
  Of 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Nova Southeastern University, College of Pharmacy-West Palm Beach, 3970 RCA Boulevard, Suite 7006A, Palm Beach Gardens, FL 33410, USA. clauson@nsu.nova.edu
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Clauson
authors.forename: Marile L
authors.initials: ML
authors.lastname: Santamarina
authors.forename: Jennifer C
authors.initials: JC
authors.lastname: Rutledge
mesh_terms: D003257:Consumer Product Safety / Q000592:standards; D019587:Dietary Supplements / Q000592:standards*; D041743:Herb-Drug Interactions; D006801:Humans; D020902:Hypericum; D010936:Plant Extracts; D011356:Product Labeling / Q000379:methods* / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D010936:Plant Extracts