An Increase in Dietary Supplement Exposures Reported to US Poison Control Centers.

INTRODUCTION: The objective of this study was to investigate the epidemiology of dietary supplement exposures in the USA. METHODS: A retrospective analysis was conducted of out-of-hospital dietary supplement exposures reported to the National Poison Data System from 2000 through 2012. RESULTS: There were 274,998 dietary supplement exposures from 2000 through 2012. The annual rate of dietary supplement exposures per 100,000 population increased by 46.1% during 2000-2002, decreased 8.8% during 2002-2005, and then increased again by 49.3% from 2005 to 2012. These trends were influenced by the decrease in ma huang exposures starting in 2002. Miscellaneous dietary supplements accounted for 43.9% of all exposures, followed by botanicals (31.9%), hormonal products (15.1%), and other supplements (5.1%). The majority of dietary supplement exposures (70.0%) occurred among children younger than 6 years old and were acute (94.0%) and unintentional (82.9%). Serious medical outcomes accounted for 4.5% of exposures and most (95.0%) occurred among individuals 6 years and older. Ma huang products, yohimbe, and energy products were the categories associated with the greatest toxicity. CONCLUSIONS: There was an overall increase in the rate of dietary supplement exposures from 2000 through 2012. Although the majority of these exposures did not require treatment at a health care facility or result in serious medical outcomes, exposures to yohimbe and energy products were associated with considerable toxicity. Our results demonstrate the success of the FDA ban on ma huang products and the need for FDA regulation of yohimbe and energy products in the USA.

Dofetilide in Overdose: A Case Series from Poison Center Data.

Dofetilide is a class III antiarrhythmic used for treating atrial dysrhythmias. Though its adverse effects are well described in routine use, very little is known about dofetilide toxicity in overdose. This is a retrospective case series of consecutive patients reported to our poison center after dofetilide overdose. Twenty-seven cases were included. Seventeen patients were treated at a healthcare facility, and of these, eight were admitted. Twenty-one patients took one extra capsule, four took someone else's medication, one took three extra capsules, and one had a large intentional overdose. Ten patients had co-ingestants reported, including three QT-prolonging agents. No one required cardioversion, defibrillation, CPR, or overdrive pacing. The patient who reported taking 90 times his usual dose in suicide attempt was the only patient to have significant clinical effects. He experienced an 8-beat run of non-sustained ventricular tachycardia, frequent multifocal PVCs, and ventricular bigeminy. He received magnesium sulfate and potassium chloride supplementation. In this series, unintentional small overdoses did not result in significant clinical effects and were often managed successfully at home, despite the fact that information showing a single capsule can cause torsades. This study is limited by its small sample size, retrospective design, and reliance on incomplete information.

Ayahuasca Exposure: Descriptive Analysis of Calls to US Poison Control Centers from 2005 to 2015.

BACKGROUND: Ayahuasca is a hallucinogenic plant preparation which usually contains the vine Banisteriopsis caapi and the shrub Psychotria viridis. This tea originates from the Amazon Basin where it is used in religious ceremonies. Because interest in these religious groups spreading as well as awareness of use of ayahuasca for therapeutic and recreational purposes, its use is increasing. Banisteriopsis caapi is rich in ß-carbolines, especially harmine, tetrahydroharmine and harmaline, which have monoamine oxidase inhibiting (MAOI) activity. Psychotria viridis contains the 5HT2A/2C/1A receptor agonist hallucinogen N,N-dimethyltryptamine (DMT). Usual desired effects include hallucination, dissociation, mood alteration and perception change. Undesired findings previously reported are nausea, vomiting, hypertension, and tachycardia. METHODS: All human exposure calls reported to the American Association of Poison Controls Centers' (AAPCC) National Poison Data System (NPDS) between September 1, 2005 and September 1, 2015 were reviewed. Cases were filtered for specific plant derived ayahuasca-related product codes. Abstracted data included the following: case age and gender, exposure reason, exposure route, clinical manifestations, treatments given, medical outcomes and fatality. RESULTS: Five hundred and thirty-eight exposures to ayahuasca botanical products were reported. The majority of the calls to poison control centers came from healthcare facilities (83%). The most common route of exposure was ingestion. Most cases were men (437, 81%, 95% CI 77.7% - 84.3%). The median age was 21 (IQR 18-29). Most exposures were acute. Three hundred thirty-seven (63%) were reported to have a major or moderate clinical effect. The most common clinical manifestations reported were hallucinations (35%), tachycardia (34%), agitation (34%), hypertension (16%), mydriasis (13%) and vomiting (6%). Benzodiazepines were commonly given (30%). There were 28 cases in the series who required endotracheal intubation (5%). Four cases were reported to have had a cardiac arrest and 7 a respiratory arrest. Twelve cases had a seizure. Reports of exposures called to poison centers appeared to increase during this period based on annual estimates. Three fatalities were reported. CONCLUSIONS: Ayahuasca use appears to be rising in the United States based on calls to poison control centers. While most use is reported to be safe and well tolerated, with possible beneficial effects, serious and life threatening adverse manifestations are possible. Most of the exposures reported to poison control centers were young people, more likely to be men and already in a healthcare facility. Further research, which includes comprehensive drug testing, will be needed to better identify the risks and effects of ayahuasca use.

The state of dietary supplement adverse event reporting in the United States.

PURPOSE: The Dietary Supplements Information Expert Committee (DSI-EC; the Committee) of the United States Pharmacopeial Convention (USP) reviews safety profiles of dietary supplements before development of USP-National Formulary (USP-NF) quality monographs. Because the veracity of dietary supplement adverse event reports (DS AERs) directly affects DSI-EC safety reviews, the Committee reviewed the current status of DS AER reporting in the US. METHODS: DSI-EC reviewed PubMed searches, information from the US Food and Drug Administration's (FDA) MedWatch program, the Toxic Exposure Surveillance System (TESS) of the American Association of Poison Control Centers (AAPCC), and reports from US and other agencies. DSI-EC analyzed this information to identify key factors that affect the quality of DS AERs. RESULTS: The overall incidence of DS AERs appears generally to be low. However, the primary reporting portal (FDA MedWatch) receives fewer AERs than do poison control centers (PCCs), and limited coordination exists among national and international surveillance programs for evaluating signals that may indicate potential public health risks. Both inadequate and poor-quality reporting of DS AERs are major limitations of DS safety monitoring in the US. CONCLUSIONS: Based on its assessments, the Committee advances recommendations to improve the quality of reporting, monitoring, and assessing DS AERs. These include (1) enhanced data collection approaches, (2) improved coordination of AER surveillance programs, (3) strengthening of educational programs for public and health care sectors, and (4) conduct of research concerning the safety of DS. If taken, these approaches are expected to improve the health and well-being of DS users.

Trends in the incidence of carbon monoxide poisoning in the United States.

PURPOSE: Recent data demonstrate that the mortality rate from carbon monoxide poisoning has declined over the past 2 decades. It is not known whether this decrease in mortality is reflective of the total burden of carbon monoxide poisoning. This study sought to examine trends in other potential indicators of the incidence of carbon monoxide poisoning in the United States. BASIC PROCEDURES: Published data from US poison control centers (PCCs) were used to calculate annual rates of calls regarding carbon monoxide exposures. Data on numbers of carbon monoxide-poisoned patients treated with hyperbaric oxygen (HBO) were used to calculate annual treatment rates. Trends in rates of carbon monoxide-related mortality, calls to PCCs, and HBO treatment were then compared. MAIN FINDINGS: Contrary to the decline in carbon monoxide-related mortality from 1968 to 1998, rates of calls to PCCs significantly increased over the same period. Neither rates of PCC calls nor HBO treatment changed significantly from 1992 to 2002. The latter 2 measures were strongly correlated. PRINCIPAL CONCLUSIONS: Although deaths from carbon monoxide poisoning have clearly decreased in the United States, other indicators of the incidence of the condition suggest that the total burden (fatal and nonfatal) may not have significantly changed. Efforts to prevent carbon monoxide poisoning should not be relaxed.

The severity of toxic reactions to ephedra: comparisons to other botanical products and national trends from 1993-2002.

OBJECTIVE: Ephedra is a botanical product widely used to enhance alertness, as a weight loss aide, and as a decongestant. Its reported adverse effects led the Food and Drug Administration (FDA) to ban ephedra-containing products in the United States in 2004. This study's purpose was to compare toxicity from botanical products containing ephedra to nonephedra products. METHODS: The Toxic Exposure Surveillance System (TESS), a national poison center database, was utilized to determine the number and outcomes of cases involving botanical products reported from 1993-2002. Cases listing both a botanical product and any other drugs or chemicals were excluded a priori. Ten-year hazard rates (moderate outcomes + major outcomes + deaths per 1000 exposures) were used to compare botanical product categories. RESULTS: There were 21,533 toxic exposures with definitive medical outcomes reported over the 10 yrs where a botanical product was the only substance involved. Of these, 4306 (19.9%) had moderate or major medical outcomes and there were two deaths, for an overall hazard score of 200 per 1000 exposures. The number of ephedra reports to poison centers increased 150-fold over the 10-yr period. The hazard rate for products that contained only ephedra was 250 per 1000 exposures and 267 per 1000 exposures for products that contained ephedra and additional ingredients; whereas the hazard score for only nonephedra botanical products was 96 per 1000 exposures. The rate ratios for multibotanical products with ephedra (RR 1.33; 95% C.I. 1.27-1.40) and for single-ingredient ephedra products (RR 1.25; 95% C.I. 1.11-1.40) were both two to six times higher than those of other common botanical products. Yohimbe-containing products had the highest hazard score (417) and rate ratio (2.08; 95% C.I. 1.59-2.80). CONCLUSION: Ephedra-containing botanical products accounted for a significant number of toxic exposures with severe medical outcomes reported to poison centers. Hazard rate analysis suggests poison center-reported events involving ephedra-containing botanical products were much more likely to result in severe medical outcomes than those involving nonephedra-containing botanical products. These data support recommendations by policymakers that the sale of ephedra should be prohibited to protect consumers. Our data suggest that the botanical product, yohimbe, may also be associated with unacceptably high risks of toxicity and should receive close scrutiny from health policymakers.

A national survey of regional poison control centers' management of occupational exposure calls.

Regional poison control centers (PCCs) were surveyed nationally to assess their policies and practices in handling work-related exposures. A 24-item survey was mailed to the executive directors of 44 American Association of Poison Control Centers' certified PCCs nationwide. The survey also requested permission to call the PCC to conduct a blinded role-playing exercise of a case of work-related trichloroethane exposure. Responses on the management questionnaire were compared with the actual responses provided by information specialists in the role-playing exercise. Seventy-five percent of PCCs completed the survey; 43% completed the telephone role-playing exercise. Survey respondents generally overestimated what they thought was routinely done to assess work-related calls, compared with what actually occurred at the time of the work-related call in the role-playing exercise. For example, 32% indicated that their PCC asked about the activities of nearby workers, but none of the PCC staff actually did so. Eighty-nine percent of the PCC executive directors surveyed thought that their staff routinely advised callers to notify their employer about work-related exposure concerns, but this occurred in only 11% of the calls. We concluded that PCCs' responses to work-related calls are inadequate. Given the public health impact of work-related calls, PCCs should develop, implement, and monitor written protocols to better address the public health issues of workplace poisonings.