Jim Kling
October 13, 2014
SAN DIEGO — Almost one-third of adverse-event reports for e-cigarettes are related to secondhand exposure, according to a US Food and Drug Administration (FDA) analysis.
The numbers are increasing, and complaints are consistent with airway irritation, nicotine exposure, and possible nicotine toxicity.
“We need to start to understand these products better, not only in users, where we have very few data, but also in nonusers,” said Beth Durmowicz, MD, medical officer at the FDA, who presented the research here at the American Academy of Pediatrics 2014 National Conference and Exhibition.
The findings suggest that, as with traditional cigarettes, parents should keep e-cigarettes away from children and avoid using or recharging them near young people.
The data are not easy to interpret, but some of the adverse events are consistent with nicotine toxicity, Dr Durmowicz told Medscape Medical News.
e-cigarettes are often advertised as safe and smoke-free, and some studies suggest that exhaled e-cigarette aerosol is less toxic than secondhand smoke from cigarettes, but there is little research on its effects on nonusers. The aerosol can contain nicotine, metal, and silicate particles, among other substances.
The researchers examined the 90 adverse-event reports submitted to the FDA from January 1, 2012 to June 30, 2014. Of these, 33 were related to nonusers.
Table 1. Nonuser Adverse Events Associated With e-Cigarettes
| Adverse Event | Total Number |
| Respiratory irritation, eye irritation, sore throat, headache, nausea, and dizziness | 21 |
| Burns or wounds from explosion | 8 |
| Incidents involving children (choking death, burns, breathing problems, raspy voice) | 4 |
The increasing number of adverse-event reports likely reflect the rapid rise in popularity of e-cigarettes, and the percentage of nonuser reports caught the agency’s attention.
“We’re seeing more and more passive-exposure reports. That was of interest to us,” said Dr Durmowicz.
Table 2. Adverse-Event Reports
| Year | User Reports, n | Nonuser Reports, n (%) |
| 2012 | 16 | 1 (6) |
| 2013 | 41 | 10 (24) |
| 2014 (Jan–June) | 51 | 22 (43) |
| Total | 108 | 33 (31) |
“These are just emerging data right now. This is uncharted territory but it has big policy implications,” meeting delegate Judith Groner, MD, attending physician at Nationwide Children’s Hospital in Columbus, Ohio, toldMedscape Medical News.
Like conventional cigarettes, electronic ones might eventually be banned from use in public spaces.
“There’s this intuitive concept that these things are safe, but do we really know that?” Dr Groner wondered. “We are now seeing all these complaints about respiratory effects. The next step is to do more descriptive research, but by then, the horse is out of the barn.”
Dr Durmowicz and Dr Groner have disclosed no relevant financial relationships.
American Academy of Pediatrics (AAP) 2014 National Conference and Exhibition: Abstract 25347. Presented October 12, 2014.