ADVERTISEMENT

2
Electronic Cigarettes: Risks to Nonusers

Sunday, October 12, 2014
San Diego Ballroom A (San Diego Marriott Marquis )
Elizabeth L. Durmowicz, MD, Ii-Lun Chen, MD and Susan F. Rudy, MSN, CRNP, Food and Drug Administration, Rockville, MD

Objectives

To evaluate potential risks of e-cigarettes to nonusers. Electronic cigarettes (e-cigarettes) are increasingly popular.1 Advertisements claim these products are “safe”, “odorless”, “smoke free”, and can be used anywhere.2,3  E-cigarette health effects data in nonusers are limited.4  Although some data suggest exhaled e-cigarette aerosol may be less toxic to nonusers than secondhand smoke,5,6 secondhand aerosol constituents are inadequately characterized and some analyses have identified volatile organic compounds,7  flavoring substances, 7 nicotine, 5,7 metal and silicate particles.8

Methods

Adverse event (AE) reports submitted to the U.S. Food and Drug Administration (FDA) from January 1, 2012 to March 31, 2014 were reviewed to evaluate adverse health effects associated with e-cigarettes in nonusers and in non-use situations. 

Results

Of 90 reports submitted on adverse health effects related to e-cigarettes, 34 involved nonusers or were not use related (Table). Twenty-one reports involved respiratory symptoms (e.g., cough, difficulty breathing, pneumonia, wheezing), eye irritation, sore throat, headache, nausea and dizziness associated with secondhand aerosol exposure. Eight reports were burns from an overheated device or from proximity to device explosion. Four nonuser reports were in children (infant choking death, burns in a three year-old, breathing problems in a three year-old and “raspy” voice in a four year-old). Secondhand exposures typically were reported in indoor spaces (e.g., bars/restaurants, workplaces, store, auditorium).


Table: Voluntary Reports to FDA on E-cigarette Adverse Events (AEs)

Year

Total # Reports1 (Total # all tobacco product reports)

Total # AE Reports2

Total Nonuser  AE Reports3

Nonuser AE Report Categories

Secondhand Aerosol Exposure

Burn 

Other4 

2012

23 (28)

 16

1   

0

0

1

2013

61 (69)

41

11  

8

2

1  

Q1 20145

45 (52)

32

20   

13

6

1

Total Reports

129 (149)

89

32

21

8

3

1 Includes adverse events, quality concerns, advice to FDA.

2 Reports with an adverse health effect.

3 Adverse events in nonusers or non-use situations.

4 Choking, cheilitis, unknown injury after device explosion

5 January – March 31, 2014

 


Conclusions

E-cigarette AE reports submitted to FDA are increasing significantly. Over one-third of reports involve nonusers or non-use situations.  Secondhand aerosol exposure complaints appear consistent with airway irritation, as well as nicotine exposure and possible nicotine toxicity. 

Healthcare providers (HCPs) should be aware that exposure to secondhand e-cigarette aerosol is potentially harmful, and e-cigarettes also pose risks of burns, choking, and nicotine poisoning.9 Additionally, aerosol deposition on indoor surfaces could result in thirdhand exposure to nicotine and other chemicals. Given the limited information available on these products and lack of regulatory oversight on manufacturing, HCPs  may consider counseling parents to keep e-cigarettes out of reach of children and avoid use, including recharging, near children.

ADVERTISEMENT