FDA investigating possible seizure risk with e-cigarette use

[WASHINGTON] The Food and Drug Administration said that it is investigating a small number of reports over several years of e-cigarette users experiencing seizures.

The potential link was seen mostly in young vapers, FDA Commissioner Scott Gottlieb and Principal Deputy Commissioner Amy Abernethy said in a statement on Wednesday. The FDA said it has received 35 reports of seizures possibly related to e-cigarette use between 2010 and early this year, and is concerned those numbers could indicate a wider phenomenon.

"We want to be clear that we don't yet know if there's a direct relationship between the use of e-cigs and a risk of seizure," Mr Gottlieb told a House appropriations subcommittee at a hearing on the agency's budget request.

The agency is raising the issue to encourage the public to report adverse events related to e-cigarettes to the FDA's online portal. Seizures are a known risk associated with ingestion of nicotine liquids used in e-cigarettes.

The FDA has been particularly concerned about an epidemic of youth vaping associated with popular e-cigarettes made by Juul Labs Inc and recently proposed to restrict sales of flavoured products in retail stores. The agency said in its statement on Wednesday that in many of the seizure reports, it couldn't identify a specific brand or sub-brand of device.

Shares of tobacco makers who are trying to diversify away from traditional cigarettes by embracing electronic devices declined on Wednesday. Altria Group, which has a a large stake in Juul Labs, fell 1.2 per cent to US$56.01 at 10.25 am in New York, while Philip Morris International Inc declined 1 per cent to US$87.14. In London, British American Tobacco shares were down about 2.1 per cent.

Altria, Philip Morris International and BAT didn't immediately return requests for comment. PMI is seeking US approval for IQOS, a device that would compete with Juul's and that is already sold in many countries. Altria has a deal to market IQOS if cleared for sale in the US.

In the reports the FDA received, some vapers reported a prior history of seizures and some reported they had used other substances such as marijuana or amphetamines along with e-cigarettes.

BLOOMBERG