Reports of seizures after e-cigarette use – US FDA

By: Atty. Benedict G. Nisperos

The U.S. Food and Drug Administration (US FDA) made a special announcement that “some people who use electronic cigarettes (e-cigarettes) have experienced seizures, with most reports involving youth or young adult users. Seizures or convulsions are known potential side effects of nicotine toxicity and have been reported in the scientific literature in relation to intentional or accidental swallowing of e-liquid found in e-cigarettes (also called vapes).”^[i]

Dr. Riz H. Gonzalez of the Philippine Pediatric Society expressed alarmed by the announcement of the US-FDA and advised Filipino parents to take notice and be cautious. According to Dr. Gonzalez, “Nicotine is a poison especially to the young and developing brains. These dangerous substances from e-cigarettes may indeed cause seizures.”

“As a pediatrician, I am deeply concerned by the growing number of e-cigarette users in the Philippines especially among the youth. I see these vape shops sprouting around selling electronic-cigarettes that look like USB appealing to the ‘techy-ness’ of the youth and worse some e-juices have candy-like flavors”, Dr. Gonzalez added.

Currently, there are around 550,000^[ii] adult users of e-cigarettes in the Philippines and around 11% of young children in the ages of 13-15 have already experimented on electronic-cigarettes.^[iii]

Meanwhile, the US has experienced alarming uptick on youth users of e-cigarettes from 2011 to 2018 particularly among its youth. Among high school students, current e-cigarette use increased from 1.5% (220,000 students) in 2011 to 20.8% (3.05 million students) in 2018 (p<0.001). During 2017-2018, current e-cigarettes use increased by 78% (from 11.7% to 20.8%. P<0.001).”^[iv] The US FDA calls the proliferation of e-cigarettes and the initiation of the youth to the product an “epidemic.”

The Philippines should learn from the experience of the United States on e-cigarettes. With the growing popularity of e-cigarettes and the sprouting of vape shops and specialty shops selling the product, it can be concluded that if Philippines does not strictly enforce existing regulations, prevalence on use of e-cigarettes will exponentially rise and the government would possibly face similar “epidemical-level rises in youth e-cigarette use” as what the US is currently experiencing.

Atty. Jacky T. Sarita, Managing Director of HealthJustice Philippines, said that under the Philippine Food and Drug Administration Administrative Order No. 2014-0008 “electronic-cigarettes should pass the safety, efficacy, and quality evaluation of the FDA first before a market authorization can be issued.”

“The Food and Drug Administration, as it has shown in the past, has proven to be an efficient regulator of products that have impact on health and are competent in safeguarding public health from potentially lethal products,” Atty. Sarita added.

In June 2018, Engr. Ana Trinidad F. Rivera, Philippine FDA Director for Cosmetics Regulation and Research, was quoted as saying that all electronic-cigarettes sold in the market right are “technically illegal”. She added that  “nobody has applied yet for the CPR because of the requirement for the clinical trials because (the device) is considered as part of smoking cessation”.^[v]

Like what US FDA has done, HealthJustice Philippines is encouraging the Philippine Food and Drugs Administration to ramp up its data gathering of incidents involving e-cigarettes and their impact to health. This will aide its efforts to evaluate the safety of e-cigarettes. Likewise, Philippine FDA may also consider issuing the following warnings made by the US FDA, to wit:

• Consumers should recognize the wide range of symptoms that may be associated with e-cigarette use and the importance of reporting new or unexpected seizures to their doctor or clinic;
• Parents, teachers, and other concerned adults should be aware that many youth are using e-cigarettes that closely resemble a USB flash drive, have high levels of nicotine and emissions that are hard to see;
• Youth and young adult users should also be aware that some e-cigarettes (also called vapes) can contain high levels of nicotine, even as much nicotine as a pack of regular cigarettes; and
• Teens who vape may end up addicted to nicotine faster than teens who smoke. Vapes may be used more frequently because they are easier to hide and may expose users to more nicotine. There are no safe tobacco products.

^[i] https://www.fda.gov/TobaccoProducts/NewsEvents/ucm635133.htm

^[ii] Global Adult Tobacco Survey for the Philippines 2015

^[iii] Global Youth Tobacco Survey for the Philippines 2015

^[iv] https://www.cdc.gov/mmwr/volumes/67/wr/pdfs/mm6745a5-H.pdf

^[v] https://www.philstar.com/nation/2018/06/01/1820466/fda-no-e-cigarettes-registered-philippines#6JdcQajEdtmiAlgB.99

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