Table 1.
General Description of Adverse Events (N = 128 Individual Cases)
| Category | N (%) |
|---|---|
| Age | |
| Not documented | 1 (1) |
| 0-23 mo | 48 (37) |
| 2-3 y | 25 (20) |
| 4-8 y | 23 (18) |
| 9-13 y | 14 (11) |
| 14-18 y | 17 (13) |
| Race | |
| Not documented | 80 (63) |
| Non-Hispanic white | 14 (11) |
| Hispanic | 12 (9) |
| African American | 2 (2) |
| Asian | 8 (6) |
| Other | 12 (9) |
| Gender | |
| Male | 55 (43) |
| Female | 55 (43) |
| Not documented | 18 (14) |
| Time of Exposure | |
| Prenatal | 10 (8) |
| Postnatal | 118 (92) |
| Main Adverse Event Reporteda | |
| Neurological (seizures, central nervous system depression, lethargy) | 45 (35) |
| Gastrointestinal (nausea, vomiting, diarrhea) | 18 (14) |
| Liver toxicity and jaundice | 14 (11) |
| Cardiovascular/hematological (hypertension, blood toxicity) | 13 (10) |
| Dermatological (rash, burns) | 12 (9) |
| Respiratory (coughing, respiratory depression) | 9 (7) |
| Endocrine/reproductive/renal | 8 (6) |
| Cyanosis | 6 (5) |
| Neonatal withdrawal (drugs or alcohol) | 2 (2) |
| Anaphylactic shock | 1 (1) |
| Route of Administration | |
| Unintentional oral ingestion | 46 (36) |
| Intentional oral ingestion | 37 (29) |
| Topically applied | 22 (17) |
| Multiple modes | 2 (2) |
| Not specified | 2 (2) |
| Unintentional exposure to skin | 1 (1) |
| Contaminated or Adulterated Products | |
| Contaminated products reported in cases | 6 (5) |
| Adulterated products reported in cases | 2 (2) |
| Documentation of testing herb in laboratory | 41 (32) |
| Documentation of laboratory work on patient | 102 (80) |
| Documentation of Exposure to heavy metals | |
| Lead | 9 (7) |
| Arsenic | 2 (2) |
| None | 117 (91) |
| Disposition | |
| Resolution of symptoms following hospitalization | 90 (70) |
| Resolution of symptoms with medications or outpatient therapy | 18 (14) |
| Death | 9 (7) |
| Disability | 7 (6) |
| Organ transplantation | 3 (2) |
| Not documented | 1 (1) |
| Location of case | |
| United States | 40 (31) |
| Europe (continental) | 26 (20) |
| Asia | 21 (17) |
| Australia | 14 (11) |
| Great Britain | 9 (7) |
| Africa | 3 (2) |
| Central America | 3 (2) |
| Unknown | 1(1) |
a
This reflects the main clinical adverse event in case. Cases may have other symptoms reported.