FDA Encourages Continued Submission of Reports Related to Seizures following E-cigarette Use

PUBLISHED: Aug 8, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (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. The FDA is requesting 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 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.

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