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1 Assistant Professor, Pharmacy Practice Drug Information Specialist College
of Pharmacy—West Palm Beach Program Nova Southeastern University Drug
Information Center 3970 RCA Boulevard, Suite 7006A Palm Beach Gardens, Florida
33410-4231 fax 561/627-0972
clauson{at}nova.edu
2 Student College of Pharmacy—West Palm Beach Program Nova
Southeastern University
3 Assistant Professor, Pharmaceutical Sciences Academic Facilitator College
of Pharmacy—West Palm Beach Program Nova Southeastern
University
Published Online, August 30, 2005. www.theannals.com, DOI 10.1345/aph.1E650b
However, we disagree with many of their assertions. Our approach was intended to be proactive rather than alarmist, and as a point of fact, we were careful to classify many of the concerns as theoretical or potential. We also believe that their letter may have misrepresented a key element of our article and provided incomplete information from the FDA. Our article noted that willow bark is not required to carry the same warning that both aspirin and nonaspirin salicylate over-the-counter products carry, which contrasts with the warnings regarding acetylsalicylic acid as stated by Vasquez and Muanza.
Perhaps the element of most concern in their letter deals with the appropriation and presentation of an incomplete conclusion by the FDA. They referred to the FDA statement that found no association between nonaspirin salicylates and Reye's syndrome. We would like to present the full intent of the FDA comments2 here:
The agency has reviewed the epidemiologic studies submitted by the comment and agrees that they did not find an association between nonaspirin salicylates and Reye's syndrome. However, these studies lacked sufficient subjects to adequately evaluate such an association.
Consequently, no firm conclusions can be made in the face of methodologic shortcomings, such as an insufficient sample size. This is similarly applicable to the statement by Vasquez and Muanza that willow bark has greater safety compared with synthetic NSAIDs and COX-2 inhibitors. If studies for willow bark were conducted of the same magnitude and length as those conducted with NSAIDs and COX-2 inhibitors or if a comparative study had been performed, then such a sweeping generalization might be made.
Currently, no true consensus exists on the issue with nonaspirin salicylates because the FDA arrived at different conclusions based on the type of evidence they examined2:
Although the agency does not have definitive evidence that drugs containing nonaspirin salicylates significantly increase the risk of Reye's syndrome, a number of case reports suggest an association.
We did not mention this in our original article, as our intent was not to unequivocally attest to an established link between willow bark and all of the safety risks, such as Reye's syndrome. A suggested association or trend does not indicate a clear correlation. However, the potential for these links and their very serious consequences merit an examination of the issue and increased awareness. We believe it is our duty as healthcare professionals to monitor for potential problems rather than simply react when adverse effects or a sentinel event occurs. Since many healthcare professionals and consumers are unaware of the safety concerns associated with dietary supplements, one key to providing this information may well be its placement on the product label.
References
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