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FDA: Adverse Events Related to E-Cigarettes Are Almost Nonexistent

Posted Feb 06 2013 11:05pm

The FDA Center for Tobacco Products’s Dr. Ii-Lun Chen describes in Nicotine and Tobacco Research (citation here ) adverse events related to e-cigarettes reported to the agency from 2008 to the first quarter of 2012.  


Adverse Events Reported to the FDA for E-cigarettes and Other Tobacco Products
YearE-cigarettesOther Tobacco Products
Up to 2008117
2009106
20101611
20111119
1st Quarter 201292

Dr. Chen notes: “…approximately half of all tobacco-related [adverse event] reports [since the late 1980s] concern electronic cigarettes, the first of which was submitted in 2008.”  A look at details of the events reveals that few reflect legitimate e-cigarette health impact.

Some “serious” complaints variously involved hospitalization for pneumonia, congestive heart failure, disorientation, seizure, hypotension, possible aspiration pneumonia, second-degree burns (from a battery explosion), chest pain and rapid heartbeat, possible infant death from choking on a cartridge, and loss of vision.  The single burn case may have been related to an e-cigarette, as there have been media reports of rare battery-related incidents ( here ).  The infant choking death, while tragic, implicates irresponsible adults who put children in proximity of ingestible objects; it is not an e-cigarette health issue.  All of the other “serious” complaints were nonspecific and probably unrelated to the product.

Dr. Chen reports that “…other e-cigarette complaints include concerns about false advertising, headache/migraine, chest pain, cough/sputum, nausea/vomiting, dizziness, feeling sick, confusion/stupor, sore throat, shortness of breath, abdominal pain, pleurisy, blurry vision, and sleepy/tired.”  He correctly adds, “Of note, there is not necessarily a causal relationship between AEs reported and e-cigarette use, as some AEs could be related to pre-existing conditions or due to other causes not reported.”

E-cigarettes are relatively new products, so it is not surprising that adverse events have surfaced in the form of “…voluntary communications from consumers, health care professionals, and concerned members of the public.” 

The bottom line is: Among millions of e-cigarette users, credible adverse events are almost nonexistent. 

 

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