August 7, 2019
“The FDA is continuing its scientific investigation to determine if there’s a direct relationship between the use of e-cigarettes and a risk of seizure or other neurological symptoms. Although we still don’t have enough information to determine if e-cigarettes are causing these reported incidents, we believe it’s critical to keep the public updated on the information we’ve received based on the agency’s initial request for reports earlier this year. We appreciate the public response to our initial call for reports, and we strongly encourage the public to submit new or follow-up reports with as much detail as possible. Additional reports or more detailed information about these incidents are vital to help inform our analysis and may help us identify common risk factors and determine whether any specific e-cigarette product attributes, such as nicotine content or formulation, may be more likely to contribute to seizures,” said Acting FDA Commissioner Ned Sharpless, M.D. “It is imperative that health care professionals, consumers, parents, teachers and other concerned adults, as well as youth and young adult users, report detailed information about any past or future incidents of seizures following e-cigarette use to the FDA. We’re committed to monitoring this issue closely and taking additional steps as necessary to protect the public, especially our nation’s youth, from the dangers of e-cigarettes and other tobacco products.”
The U.S. Food and Drug Administration provided an update today on its ongoing scientific investigation of a potential safety issue related to seizures reported following e-cigarette use and is continuing to encourage the public to submit new or follow-up reports on this topic as requested in the agency’s announcement in April.
The FDA has posted additional reports the agency has received since April related to e-cigarette users experiencing seizures. These additional reports of events that occurred over the last 10 years do not necessarily indicate an increase in frequency or prevalence of such incidents. In addition, some users reported other serious neurological symptoms such as fainting or tremors, which may or may not be related to seizures. In total, including those posted in April, the agency has received 127 reports of seizure or other neurological symptoms that occurred between 2010 and 2019. As part of its commitment to keeping the public informed about this issue, the FDA plans to post additional reports it receives moving forward with the agency’s normal quarterly updates of tobacco problem reports on its website.
The FDA is continuing to seek more information to better understand whether there is a relationship between e-cigarette use and neurological events and is asking that any unexpected health or product issues experienced with e-cigarettes or any tobacco product be reported to the FDA through the Safety Reporting Portal. Information about the specific product used (including brand name), whether it was modified in any way or if other tobacco products, medications, supplements or other substances were used, as well as details about the pattern, manner and timing of product use preceding the adverse event and any underlying medical conditions, are all critical pieces of information to help fully assess this issue. Submitting follow-up reports containing test results and information about whether the symptoms have stopped or continued with or without continued tobacco product use can be equally important. Additionally, health care professionals assessing neurological symptoms should ask patients about e-cigarette use and help patients report adverse experiences by referring patients to the FDA website, making relevant medical records available or submitting a report on a patient’s behalf.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.