More Information Needed to Determine Possible Causes
Since initially alerting the public on April 3 to reports of some e-cigarette users experiencing seizures, FDA has since received 118 new reports of similar incidents. In total, including those posted in April, the agency has received 127 reports of neurological events following e-cigarette use that occurred between 2010 and 2019. This does not necessarily indicate an increase in frequency or prevalence of such incidents.
At this time, FDA has not been able to identify any specific brand of tobacco product, or identifiable product problem, associated with these incidents. However, the agency remains concerned about the possibility of an association between e-cigarette use and seizures or other similar medical conditions and encourages the public, including e-cigarette users and medical professionals, to provide as much information as possible when reporting health or safety problems stemming from tobacco products through the online Safety Reporting Portal (SRP).
Healthcare providers in particular are reminded to ask patients about e-cigarette (or “vape” use), particularly when providing care following a neurological event. Healthcare providers are also encouraged to help patients to report any adverse experiences from tobacco use through the Safety Reporting Portal, such as referring patients to the website, making relevant medical records available, or submitting a report on a patient’s behalf. FDA has posted the full reports [PDF – 23MB], redacted in accordance with applicable laws, as a reference for those reporting seizures or other neurological symptoms following e-cigarette use.
Details about adverse experiences are important in helping FDA to identify concerning trends and clear patterns or causes for particular incidents. When reporting an adverse experience, please be sure to include as much information as possible about:
- The affected person (whether a user or nonuser)
- The name of the manufacturer
- The brand name, model, and serial number of the device or e-liquid, if applicable
- Where the device or e-liquid was purchased
- If the device or e-liquid was modified in any way or if the device malfunctioned
- Any use or exposure to other tobacco products, medications, supplements, substances of abuse or toxins around the same time
- Any other symptoms or warning before the adverse experience, such as nausea, vomiting, change in the user’s behavior, alertness, vision or hearing
- Details about the pattern of product use or exposure before the adverse experience (duration, amount and intensity of e-cigarette use) as well as the time between the latest use and the adverse experience
- Details about health effects, including specific areas of the body affected, how symptoms progressed, how long they lasted, the course of the recovery, and the medical testing or care and decisions rendered
- If you had testing for levels of nicotine, cotinine or other byproduct in your blood or urine, include results and the time between the last product use and the body fluid collection
- Underlying health conditions and health history, especially any history of seizures earlier in life and any blood relatives with a history of seizures
- Whether product use continued or not after the event and whether additional events occurred
- Whether you reported the event elsewhere, such as to a poison control center, the retailer, or the manufacturer
Safety Reporting Portal users can upload relevant medical records, photos, or other files that include or supplement this information. Providing follow-up information weeks, months, or years later that are linked to the initial report and give final outcomes can also be useful.
FDA – August 7, 2019.