Clauson Kevin A, Santamarina Marile L, Rutledge Jennifer C
Nova Southeastern University, College of Pharmacy-West Palm Beach, 3970 RCA Boulevard, Suite 7006A, Palm Beach Gardens, FL 33410, USA.
BMC Complement Altern Med. 2008 Jul 17;8:42. doi: 10.1186/1472-6882-8-42.
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.
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.
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.
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.
圣约翰草用于治疗抑郁症，在美国、加拿大及欧洲部分地区很受欢迎。然而，圣约翰草与包括华法林、环孢素、茚地那韦和口服避孕药在内的处方药之间存在已记录的相互作用。关于这些安全考虑因素的一个信息来源是产品标签。本研究的目的是评估美国具有全国代表性的圣约翰草产品标签中包含的临床相关安全信息。
确定了八个临床相关安全问题：药物相互作用（圣约翰草与抗逆转录病毒药物、圣约翰草与免疫抑制剂、圣约翰草与口服避孕药、圣约翰草与华法林）、禁忌证（双相情感障碍）、治疗重复（抗抑郁药）以及一般注意事项（光毒性和建议咨询医疗保健专业人员）。确定了一份圣约翰草产品清单以评估其标签。使用百分比和总数来呈现研究结果。
在评估的74种产品中，没有产品标签涵盖所有8项评估标准的信息。三种产品（4.1%）提供了8项标准中7项的信息。四种产品未提供任何安全信息。带有标签信息的产品百分比分别为：圣约翰草与抗逆转录病毒药物（8.1%）、圣约翰草与免疫抑制剂（5.4%）、圣约翰草与口服避孕药（8.1%）、圣约翰草与华法林（5.4%）、双相情感障碍（1.4%）、抗抑郁药（23.0%）、光毒性（51.4%）以及咨询医疗保健专业人员（87.8%）。标签上的其他安全相关信息包括关于妊娠的警告（74.3%）、哺乳期（64.9%）、出现不良反应时停药（23.0%）以及18岁以下患者禁用（13.5%）。产品标签上预先设定的安全问题平均数量为1.91（范围0 - 8），完整性为23.9%。
绝大多数圣约翰草产品未能在其标签上充分解决临床相关安全问题。少数产品确实提供了关于临床相关安全问题的可接受信息量，这可能会提高医疗保健专业人员和健康商店店员的咨询质量。如果美国食品药品监督管理局重新审视膳食补充剂的标签要求，医疗保健专业人员和消费者可能会受益。
