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

Area of Science:

• Pharmacology
• Herbal Medicine
• Regulatory Science

Background:

• St. John's wort (SJW) is widely used for depression but has known interactions with prescription drugs.
• Product labeling is a key source of safety information for consumers and healthcare professionals.
• Evaluating the completeness of SJW product labeling is crucial for public health.

Purpose of the Study:

• To assess the clinical relevance and completeness of safety information provided on St. John's wort product labels in the USA.
• To identify specific safety issues inadequately addressed by SJW labeling.

Main Methods:

• Identified eight clinically relevant safety issues for St. John's wort (SJW).
• Evaluated labels of a national sample of SJW products for the presence of this safety information.
• Used percentages and totals to report findings on label completeness.

Main Results:

• None of the 74 evaluated SJW products provided information on all 8 safety criteria.
• Label information was notably lacking for drug interactions (e.g., SJW-warfarin, SJW-immunosuppressants) and contraindications (e.g., bipolar disorder).
• While 87.8% advised consulting a healthcare professional (HCP), only 4.1% covered 7 of 8 criteria, with an average completeness of 23.9%.

Conclusions:

• The majority of St. John's wort (SJW) products fail to provide adequate clinically relevant safety information.
• Improved labeling could enhance counseling by healthcare professionals (HCPs) and health store clerks.
• Re-evaluation of FDA labeling requirements for dietary supplements is recommended to improve consumer safety.