The FDA has released an emergency safety issue addressing reports of seizure events among teens and young adults who use e-cigarettes. Research has shown nicotine toxicity, which can occur when e-liquid is swallowed, can cause seizures and convulsions. FDA says there has been a recent surge in voluntary reports of adverse reactions to tobacco products, including seizures.
The safety issue said FDA has been receiving voluntary adverse experience reports about tobacco products since 1988 but since June 2018, noticed an increase in seizure reports. After examining poison control centers' reports between 2010 and early 2019, the FDA said 35 reported cases of seizures mentioning a use of e-cigarettes which may be higher since reporting is voluntary. On the other hand, other factors could be at play, including prior seizure diagnosis, use of other substances (e.g., marijuana, amphetamines, etc.). Also, since the brand names of e-cigarettes are missing from the reports, FDA is unable to determine if problems are linked to specific e-cigarette manufacturers.
“We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure,” noted FDA Commissioner Scott Gottlieb in a separate announcement. “We can’t yet say for certain that e-cigarettes are causing these seizures. We’re sharing this early information with the public because as a public health agency, it’s our job to communicate about potential safety concerns associated with the products we regulate that are under scientific investigation by the agency.”
Healthcare providers should be aware, said the safety issue, that seizures may be associated with e-cigarette use and redacted reports of past incidents are available on the FDA website and may assist medical evaluations of seizures.
“We’re asking that any unexpected health or product issues experienced with e-cigarettes or any tobacco product be reported to the FDA through our Safety Reporting Portal,” said Gottlieb. “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 product use preceding the adverse event, are critical pieces of information to help fully assess this issue more broadly.”
