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They report a total of 35
incidents between 2010 and 2019, however a significant increase in reporting
rates has taken place since 2018. There is the belief that the reported
number of such seizures may underrepresent the true incidence as reporting is both
voluntary and seizures observed may not always be connected to e-cigarette
use. Of significant concern, these reports were most often involving
youth or young adult users of such products. Seizures, and/or
convulsions, are a known adverse effect of nicotine toxicity, and in the past
were most often associated with ingestion (whether accidental or intentional)
of e-liquid. These more recent reports have instead been linked with what
can be considered more “normal” or expected use via inhalation using e-cigarettes.
Reported seizures have occurred in both first-time and “experienced” users, as
well as those with and without seizure histories. In some situations,
events have also been in association with other substance use (ex. marijuana,
amphetamines). Based on the reports submitted, seizures have occurred
after varying degrees of use — in some reports after a few puffs while in other
instances up to a day after use. As e-cigarettes are not regulated, the
true nicotine concentration is not verifiable to consumers, health care
providers, or government authorities. In addition, contamination concerns
exist.
The FDA is asking for both the
public and medical providers to report safety concerns regarding nicotine
products, whether it is a minor issue or something as serious as a
seizure. Reports can be filed to the FDA via their Safety Reporting
Portal for Tobacco Products (click here to be directed to the portal: https://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/ucm377563.htm ). Via this portal, the FDA encourages
reporting of both health/safety concerns, as well as quality concerns.
Examples of quality concerns may include damaged/defective products, contamination
concerns, as well as tobacco products that my not smell or taste as they
normally do. Health/safety concerns may include:
In order to help the FDA better
monitor safety issues regarding tobacco products, please consider filing
reports if noted in your patients.
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