Published Online, 30 August 2005, www.theannals.com, DOI 10.1345/aph.1E650a.
The Annals of Pharmacotherapy: Vol. 39, No. 10, pp. 1763. DOI 10.1345/aph.1E650a
© 2005 Harvey Whitney Books Company.
Comment: evaluation of presence of aspirin-related warnings with willow bark
Alex Vasquez, DC ND1, and
Dave N Muanza, PhD2
1 Researcher Biotics Research Corporation 6801 Biotics Research Drive
Rosenberg, Texas 77471-5755 fax 281/344-0725
avasquez{at}bioticsresearch.com
2 Lab Director Biotics Research Corporation
Published Online, August 30, 2005. www.theannals.com, DOI 10.1345/aph.1E650a
TO THE EDITOR: In their recent article, Clauson et
al.1
suggested that the dietary supplement willow bark presents a safety risk to
the public due to the presence of salicylates and the current regulations that
do not require willow bark supplements to carry the same label warnings as
products containing acetylsalicylic acid. While we agree that products need to
be appropriately labeled, especially when certain ingredients may present a
risk to specific groups of consumers/patients, we found this article to be
inappropriately alarmist because the authors did not scientifically support
their claims that willow bark increases the risk of hemorrhage, anti-coagulant
effects, gastric ulceration, or induction of Reye's syndrome in humans.
As mentioned by the authors, there is only a single case report in the
literature of an allergic reaction to willow bark in a patient with previous
aspirin allergy. Furthermore, Clauson et al. failed to note that the
anticoagulant action of acetylsalicylic acid is specific to aspirin and is not
seen with dietary
salicylates.2
More conclusively, the Food and Drug Administration (FDA) issued a final
ruling in 2003 stating that its reviewers "did not find an association
between nonaspirin salicylates and Reye's
syndrome."3
Therefore, with the exception of allergic reactions in patients with aspirin
sensitivity, other aspirin-related label warnings are unwarranted on willow
bark products. The fact that manufacturers have not thus labeled their
products does not indicate a shortcoming of the nutritional industry nor of
regulatory agencies.
Salicylates are found in many commonly consumed fruits, vegetables, herbs,
and spices and are partly responsible for the health-promoting benefits of
increased fruit and vegetable
consumption.2
As a source of salicylates, willow bark has proven to be an effective
analgesic with few adverse
effects.4 It
is thus an attractive alternative for patients seeking relief of
musculoskeletal pain due to its excellent
cost-effectiveness5
and apparently greater safety compared with synthetic nonsteroidal
antiinflammatory drugs (NSAIDs) and cyclooxygenase (COX)-2 inhibitors, the
latter of which are well known to significantly induce gastropathy and adverse
cardiovascular events.
Footnotes
Biotics Research Corporation is a Food and Drug Administration-approved
facility that manufactures willow bark.
References
- Clauson KA, Santamarina ML, Buettner CM, Cauffield JS. Evaluation
of presence of aspirin-related warnings with willow bark. Ann
Pharmacother 2005;39:1234-7. Epub 31 May 2005. DOI10.1345/aph.1E650[Abstract/Free Full Text]
- Hare LG, Woodside JV, Young IS. Dietary salicylates. J Clin
Pathol 2003;56:649-50.[Free Full Text]
- Food and Drug Administration, HHS. Labeling for oral and rectal
over-the-counter drug products containing aspirin and nonaspirin salicylates;
Reye's syndrome warning. Final rule. Fed Regist 2003;68:18861-9.[Medline]
- Chrubasik S, Eisenberg E, Balan E, Weinberger T, Luzzati R, Conradt
C. Treatment of low back pain exacerbations with willow bark extract: a
randomized double-blind study. Am J Med 2000;109:9-14.[Medline]
- Chrubasik S, Kunzel O, Black A, Conradt C, Kerschbaumer F.
Potential economic impact of using a proprietary willow bark extract in
outpatient treatment of low back pain: an open non-randomized study.Phytomedicine
2001;8:241-51.[Medline]
