FDA Alerts Public About Seizures Reported After E-Cigarette Use

FDA Alerts Public About Seizures Reported After E-Cigarette Use

In a special announcement, the Food and Drug Administration (FDA) has notified the public of a “slight but noticeable increase” in reports of e-cigarette users experiencing seizures. Although the frequency is low, the agency wants to make sure that healthcare providers and consumers are aware of the risk and the importance of reporting such seizures to the FDA.

Part of the urgency surrounding the FDA action is that most reported cases of seizures involve youth or young adult e-cigarette users. By every measure, youth vaping has skyrocketed in the last several years, with 1.5 million middle and high schoolers vaping for the fist time in 2018.

According to an FDA review, there have been 35 reported cases of seizures associated with e-cigarettes in less than a decade. The review looked at reports made to the agency and those made directly to poison control centers. Because these reports are voluntary, it is probable that many cases remain unreported.

“While 35 cases may not seem like much compared to the total number of people using e-cigarettes,” said FDA Commissioner Scott Gottlieb and Principal Deputy Commissioner Amy Abernethy, “we are nonetheless concerned by these reported cases.”

There is simply a lot that regulators do not know at this point. Seizures have been reported by first-time and experienced e-cigarette users. There are not many reports, nor do they “provide enough detail to establish a clear pattern or cause for these incidents,” said Gottlieb and Abernathy.

One fact not in question is that nicotine has the ability to provoke seizures in both animals and humans. This is something that e-cigarette manufacturers and regulators have been aware of for some time. Since 2015, however, e-cigarettes have become much more powerful, delivering unprecedented levels of nicotine to users.

Do the increased levels of nicotine have anything to do with the rising reports of seizures?

FDA Calls for More Information

At this time, the FDA is not saying for certain that e-cigarettes cause seizures. Rather, the agency is raising awareness about a potentially serious health issue with the public, and encouraging people who have been affected to come forward.

“We need more information before we can determine if there’s in fact a link,” said Gottlieb and Abernathy. “It’s our hope that these public steps to solicit additional reports of adverse events, along with other agency efforts, will allow us to understand whether there’s a connection.”

The FDA is actively seeking information regarding a wide range of adverse events related to e-cigarette use, not just seizures. E-cigarettes pose a number of serious health issues, especially to young people with developing brains. According to the U.S. Surgeon General, e-cigarette risks include:

  • Nicotine addiction
  • Mood disorders
  • Permanent lowering of impulse control
  • Exposure to harmful chemical and compounds (such as diacetyl, benzene, nickel, tin, and lead)
  • Explosion

These risks, like the risk of seizures, are not fully understood with regards to e-cigarettes. The FDA recognizes that these devices may prove to be an important new pathway for smokers to quit — and yet, at the same time, the use of this technology needs to be monitored to make sure everyone understands all the risks involved.

Gottlieb and Abernathy noted some of the ongoing research into the e-cigarette safety, but new and more powerful products continue to appear. Depending on how these devices are used or modified, they can affect the amount of nicotine they deliver, which further complicates the roles regulators play in keeping people safe in this rapidly expanding market.

How to Recognize a Seizure — And Why They Might Be Underreported

When someone is having a seizure, they have uncontrolled or abnormal electrical activity in their brain. Not all seizures result in body-shaking convulsions. Some do, but according to the FDA, other outward signs of seizures may include:

  • Lapses in awareness or consciousness
  • Staring blankly into space for a few seconds or suddenly stopping movement
  • Falling down
  • Feeling fine, sleepy, confused or having a headache afterwards
  • Trouble remembering what they were doing or what happened prior to the seizure

Seizures can last anywhere from a few seconds to a few minutes. Any seizure over 5 minutes is a medical emergency. Typically, seizures don’t do any long-term harm, but they need to be addressed in order to prevent future episodes. Learn more about seizure first-aid.

In the popular imagination, seizures are events where someone’s body is completely out-of-control. While that happens in some cases, other symptoms are easy to miss, or could be mistaken for something else. Because of the emerging connection between e-cigarettes and seizures, it’s important that people can accurately recognize and report such events.

The better information people can report to the FDA, the better the agency will be able to make informed decisions about public health.

Report a problem with a tobacco product to the FDA.

Author:Sokolove Law
Sokolove Law

The Sokolove Law Content Team consists of writers and editors who work alongside the firm’s attorneys and case managers. The team strives to present the most accurate and relevant information for those who need legal help.

Last modified: October 8, 2019