In March 2011, the American Botanical Council’s HerbalEGram reported that the American Association of Poison Control Centers’ (AAPCC) 2009 annual report listed an “unknown dietary supplement or homeopathic agent” as being involved or associated with 1 single-substance exposure fatality.1 ABC has since acquired new information on the details surrounding the death, suggesting that the unknown products are not being implicated as a cause.
In the aforementioned HerbalEGram article, ABC Founder and Executive Director Mark Blumenthal noted that, from a public policy perspective, the lumping together of dietary supplements and homeopathic agents into 1 category creates “considerable confusion,” due to the fact that homeopathic medicines are regulated as drugs by the US Food and Drug Administration, while dietary supplements are regulated as a legal subset of foods. He added that “since homeopathic products generally consist of highly diluted preparations, their ability to cause a serious adverse event which results in death is highly questionable.”1 Additionally, in its annual reports for the 2 years preceding 2009, the AAPCC reported no fatalities associated with single-substance exposure to a dietary supplement.2,3
In order to provide clarifying details of the case, in accordance with AAPCC policy, ABC purchased the abstract of the 2009 “unknown dietary supplement or homeopathic agent” fatality from the AAPCC. According to the report, the deceased was a 49-year-old woman with terminal breast cancer. Her chemotherapy was discontinued several months prior to her death and she had been treating herself with an unknown homeopathic chemotherapeutic agent and an unknown pain medication. She was also using a colon cleanser.4 She experienced a respiratory arrest in her home and subsequently transported to hospital by EMS where she arrived unresponsive with a low blood pressure. She was not able to be resuscitated.
Alvin C. Bronstein, MD, lead author of the AAPCC 2009 annual report, told ABC that since the exact details of the homeopathic chemotherapy were not known and the colon cleanser product was not in the AAPCC products database utilized by the National Poison Data System (NPDS), the colon cleanser was assigned to the category “unknown dietary supplements or homeopathic agents,”—a broad, generic classification (personal communication, June 8, 2011). Two of the ingredients of the colon cleanser were later identified on the product’s website as magnesium and citric acid. It is AAPCC’s policy to release data by product name only to that product’s manufacturer.
“The patient was already enroute to the medical center when the poison control center was called,” said Dr. Bronstein. “I don’t think the [homeopathic] product or colon cleanser had anything to do with it,” he stated, noting the patient’s terminal breast cancer and the many “unknowns” of the case.
As a part of the review of each fatality, the clinical team at the poison center rates the relative contribution of the substances involved to the fatality (RCF) as one of the following categories:
1-Undoubtedly responsible
2-Probably responsible
3-Contributory
4-Probably not responsible
5-Clearly not responsible
6-Unknown
Both the poison center clinical team and the independent AAPCC fatality review team judged the RCF for this case as “6-Unknown,” which is defined as “clinical case evidence is insufficient to impute or refute a causative relationship for the substances in this death.”4,5 Thus, although a death did occur in a patient with breast cancer using the colon cleanser, the clinical evidence did not support a causative relationship.
“We appreciate the cooperation of the AAPCC in providing ABC the information to help clarify the details of this case,” said Blumenthal. “This information confirms that no dietary supplement was implicated in the only case of a single-substance exposure fatality in the 2009. This is at least the third year in a row in which no herbal or other dietary supplement was associated with a single-substance exposure death in AAPCC’s annual reports. This information, as well as other relevant data, strongly suggests that herbs and other dietary supplements are one of the safest categories of consumer products.”
—Ashley Lindstrom
References
1. Lindstrom A. National poison control center database annual report reflects safety of dietary supplements. HerbalEGram. Available at: cms.herbalgram.org/heg/volume8/03March/AAPCC2009report.html. Accessed June 9, 2011.
2. American Association of Poison Control Centers. 2007 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): revised charts. Available at: www.aapcc.org/dnn/Portals/0/2007_Annual_Report%20_Updated_Tables_6_7_14_17B_17C_22A_22B_25_Jan_11_FOR_POSTING.pdf. Accessed June 10, 2011.
3. American Association of Poison Control Centers. 2008 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 26th Annual Report. Available at: www.aapcc.org/dnn/Portals/0/2008annualreport.pdf. Accessed June 10, 2011.
4. American Association of Poison Control Centers. AAPCC NPDS Fatality Abstract 2009. Case Number: 71863553.
5. American Association of Poison Control Centers. 2009 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 27th Annual Report. Available at: www.aapcc.org/dnn/Portals/0/correctedannualreport.pdf. Accessed June 10, 2011.
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