Clinically relevant safety issues associated with St. John's wort product labels

Clauson, Kevin A.; Santamarina, Marile L.; Rutledge, Jennifer C.
January 2008
BMC Complementary & Alternative Medicine;2008, Vol. 8, Special section p1
Academic Journal
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%), SJWwarfarin (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. Conclusion: 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.


Related Articles

  • St. John's Wort And Rx Drugs: Here's More Bad News.  // RN;Dec2003, Vol. 66 Issue 12, p24 

    Reports on a study on the probability that Saint John's wort supplements will interfere with a patient's prescription medication. Herbal remedy's alteration of the P450 enzymes, the hepatic system intimately involved in the metabolism of marketed drugs; Possible requirement of dosage...

  • The Public's Perception of Supplements.  // Health & Stress;2002, Issue 3, p6 

    Examines the public perception towards dietary supplements in the United States. Benefits gained from supplements; Need for public education on prescription drug interaction; Design of the Dietary Supplement Education Alliance consortium.

  • About herbal supplements.  // Patient Care for the Nurse Practitioner;Jul2004, Vol. 7 Issue 7, p13 

    The article offers a guide for patients on the use of herbal supplements. A patient may not think that herbal supplements are medicine, but they act like medicine in the body. The labels on their packages do not have to list all the ingredients or strength. Some combinations can be dangerous and...

  • supplement facts. Turner, Lisa // Better Nutrition;Nov2013, Vol. 75 Issue 11, p50 

    The article presents information on recommendations which have been developed for several types of nutritional supplements, including probiotics, vitamin D and multivitamins, which consumers should take on a daily basis. Information that consumers can use to better understand information on...

  • 'What am I taking, again?'. Maes, Luc // Better Nutrition;Mar99, Vol. 61 Issue 3, p18 

    Focuses on potential interactions betweens dietary supplements and drugs. Medication interfering with vitamin B-12 absorption; Overprescribed antibiotics; Overindulgence in coffee and soda.

  • Vitamin/herb combos pose dangers. Chase, Sandra L. // RN;Dec98, Vol. 61 Issue 12, p85 

    Reports on the dangers from vitamin/herb combinations. Ginseng's reduction of the effects of certain antihypertensive drugs; Adverse effects of chromium; St. John's wort; Nutrient called coenzyme Q-10.

  • Phytotherapy Review & Commentary: St. John's Wort and Depression: Avoiding Drug Interactions. Bone, Kerry // Townsend Letter;Jan2007, Issue 282, p45 

    The article discusses the balance of the clinical evidence which suggests that hypericum perforatum, commonly known as St. John's wort (SJW), is a herbal treatment for depression in the U.S. The author emphasizes that SJW is safe and effective for the short-term relief of mild to moderate...

  • Depression-lifting supplements that work. Knittel, Linda // Natural Foods Merchandiser;May2006, Vol. 27 Issue 5, p38 

    The article focuses on certain herbs, vitamins and other supplements that help in lifting symptoms of depression without the unwanted side effects. Professional help is required to determine the nature and severity of the condition. St. John's wort commonly known as Hypericum perforatum is an...

  • Supplement safety.  // Consumer Reports;Nov2013, Vol. 78 Issue 11, p6 

    The article looks at U.S. laws around nutritional supplements. Topics include the limited authority the U.S. Food and Drug Administration (FDA) has over whether supplements can be sold in stores, the lack of labeling to indicate potentially serious side effects and drug interactions, and...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics