FWD 2 National Poison Control Center Database Annual Report Reflects Safety of Dietary Supplements

HerbalEGram: Volume 8, Number 3, March 2011

National Poison Control Center Database Annual Report Reflects Safety of Dietary Supplements


After 2 sequential years of reporting no deaths associated with dietary-supplement use in its annual reports for 2007 and 2008, the American Association of Poison Control Centers’s (AAPCC) recently published 2009 annual report listed an “unknown dietary supplement or homeopathic agent” as involved or associated with 1 fatality.1 In 2009, the National Poison Data System (NPDS), which compiles exposures reported to the AAPCC’s 61 United States poison centers, recorded a total of 1,158 deaths, with pharmaceutical drugs listed as the chief substance involved in those reported poisoning fatalities.2

The AAPCC is a nonprofit organization, founded in 1958, which comprises poison centers for all 50 United States, as well as Guam, Puerto Rico, the US Virgin Islands, American Samoa, the Federated States of Micronesia, and the District of Columbia.2,3 Experts at these centers can be reached by phone at no charge, and are available 24 hours a day, every day.2 All calls are documented and tracked in the NPDS. (More information is available at www.aapcc.org.)

According to Elise Bailey, MSPH, AAPCC’s associate director of toxicosurveillance, a number of substances fall into the realm of “unknown dietary supplements or homeopathic agents,” including aloe (Aloe vera), apple pectin (Malus spp.), and acidophilus (personal communication, February 22, 2011).  “It’s also possible that it was a truly unknown supplement,” said Bailey. The AAPCC does not own the software program that assigns codes to reported agents, according to Bailey, who was unable to access additional information on the “unknown dietary supplement/homeopathic agent”—or the details of the fatal incident—without incurring costs. “Our data is housed off-site,” she said, “so we have limited access to certain things.”

Rose Ann Soloway, RN, MSEd, DABAT—a clinical toxicologist at the National Capital Poison Center and former Administrator/Associate Director at AAPCC—elaborated on what might result in categorization as an “unknown dietary supplement or homeopathic agent.” “Examples might be when tablets were loose or the bottle was thrown away or not available when the person was being evaluated or having a history taken, among other possibilities,” she said (e-mail, February 23, 2011).

The American Botanical Council’s Founder and Executive Director Mark Blumenthal suggested that for a variety of reasons, the AAPCC should re-evaluate the system it uses for classification of incidents reported in its database. “Putting dietary supplements and homeopathic products into the same general category can create considerable confusion when trying to draw any meaningful interpretations from the raw data contained in the database,” he said. “First, homeopathic products are drugs according to federal law, not foods or dietary supplements (which are technically foods). They should not be in the same category with herbs and other supplements.”

“Second,” he noted, “since homeopathic products generally consist of highly diluted preparations, their ability to cause a serious adverse event which results in death is highly questionable, and, at the very least, infinitesimally rare.”

“The bottom line, in this case,” Blumenthal added, “is that AAPCC should have a system in which the data are more transparent. For the AAPCC to tell ABC during its investigation of this article that it cannot identify the type of substance or product which it is associating with the only alleged death which might possibly be even remotely related to a dietary supplement is disappointing and does not instill confidence nor provide any significant value to numerous stakeholders in the public health arena.”

Richard Kingston, PharmD, president of regulatory and scientific affairs at SafetyCall International Poison Center, noted that the AAPCC’s database is just one of many poison-exposure databases (personal communication, February 11, 2011). As such, the numbers in the annual report do not necessarily reflect absolute relationships between suspected exposures to various substances and the reported clinical effects. Furthermore, according to Dr. Kingston, it is possible that there are other fatalities that have occurred where dietary-supplement involvement may have been suspected. However, Dr. Kingston said, “despite people who think there’s a relationship, it’s not always that straightforward.” SafetyCall International is a private healthcare practice and poison control center that is academically affiliated with the University of Minnesota. SafetyCall runs a 24-hour, 7-day “adverse event call center,” in addition to offering adverse event reporting and data analysis services to corporate clients worldwide (more information is available at www.safetycall.com).4  Dr. Kingston, who also serves as a clinical professor of pharmacy at the University of Minnesota College of Pharmacy in Minneapolis, said, “Even in the circumstance of exposure, [the 2009 AAPCC annual report] confirms what we believe to be a fairly wide range of safety for botanical products.”

The AAPCC’s 2004 report included 10 dietary supplement-associated deaths; the next year, 13 dietary supplement-associated deaths appeared in the report.5,6 That number dropped drastically in 2006, when only two were recorded by the AAPCC.7 The following 2 years—2007 and 2008—no such fatalities appeared in the AAPCC’s annual report.8,9

According to Soloway, the reports do not provide sufficient information to identify exactly why supplement-associated fatalities have decreased (e-mail, February 11, 2011). She did point to 2 regulatory changes that may have affected fatality rates:

“Several years ago, iron in adult-strength dietary supplements… was a leading cause of poisoning death in children,” said Soloway. “After education and regulation, these deaths have become rare.”  (Dr. Kingston added that “widespread use of child-resistant closure and special blister packaging has further decreased accidental childhood exposure, poisoning, and deaths to these and other substances.”)

“In more recent years,” Soloway continued, “ma huang [Ephedra sinica] was associated with a number of fatalities (several in 2004); these dropped after ma huang/ephedra was banned in 2005.”

According to a press release from the AAPCC, “[S]edatives/hypnotics/antipsychotics, cardiovascular drugs, opioids, and acetaminophen combinations were most frequently associated with poison-related deaths [in 2009].”2

“If you look at pharmaceutical drugs,” said Dr. Kingston, “we see numerous reports of both accidental and intentional deaths.” Herbal supplements, Kingston stated, are not as “amenable to abuse, so the likelihood of excessive intake leading to any kind of serious adverse consequence is extremely low.”

With regard to botanicals, he noted, “When you deviate from historical or cultural uses and/or preparations (e.g., concentrated extracts), such as what occurred with ephedra, adverse consequences can occur. Subsequent to the withdrawal of ephedra, the overall adverse incident rate associated with the use of either botanicals or other dietary supplements has dropped. At the end of the day, like others, I’m struck by the relatively low number of minor, or rare reports of serious adverse effects reported for this class of product, especially as compared to mainstream pharmaceuticals. That should be good news for any consumer looking to herbs and other dietary supplements in pursuit of natural options to meet their overall health and wellness goals.”  


—Ashley Lindstrom

References

1. 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 February 11, 2011.

2. American Association of Poison Control Centers: medicines remain the leading cause of poison deaths in 2009 [news release]. Alexandria, VA: American Association of Poison Control Centers; January 7, 2011. Available at: www.aapcc.org/dnn/Portals/0/prrel/NPDS-generalpresser2USE.pdf. Accessed February 11, 2011.

3. About AAPCC. The American Association of Poison Control Centers website. Available at: www.aapcc.org/dnn/AAPCC/AboutAAPCC.aspx. Accessed on February 24, 2011.

4. SafetyCall International website. Available at: www.safetycall.com/. Accessed on February 24, 2011.

5. American Association of Poison Control Centers. 2004 Annual Report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Available at: www.aapcc.org/dnn/Portals/0/AJEM%20-%20AAPCC%20Annual%20Report%202004.pdf. Accessed on February 21, 2011.

6. American Association of Poison Control Centers. 2005 Annual Report of the American Association of Poison Control Centers’ national Poisoning and Exposure Database. Available at: www.aapcc.org/dnn/Portals/0/2005%20Published%20Annual%20Report.pdf. Accessed on February 21, 2011.

7. American Association of Poison Control Centers. 2006 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS). Available at: www.aapcc.org/dnn/Portals/0/2006%20Annual%20Report%20Final.pdf. Accessed on: February 21, 2011.

8. 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 on February 21, 2011.

9. 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 on February 21, 2011.