Thursday, 4 April 2019

FDA Probing Link Between Seizures and Vaping

FDA Probing Link Between Seizures and VapingDan Kitwood/GettyThe FDA announced Wednesday that it was investigating reports of seizures in teens who vape—the latest in the agency’s increased focus on the e-cigarette industry.“We have reports indicating that some people who use e-cigarettes, especially youth and young adults, are experiencing seizures following their use,” FDA commissioner Scott Gottlieb and Principal Deputy Commissioner Amy Abernathy said in a statement, noting that there have been at least 35 reported cases of seizures following e-cigarette use between 2010 and 2019 documented by poison control centers and the administration’s own adverse events reporting system. “While 35 cases may not seem like much compared to the total number of people using e-cigarettes,” the statement added, “we are nonetheless concerned by these reported cases.” Gottlieb, who will retire from the agency on Friday after months of crusading against the e-cigarette industry and two years at the FDA, emphasized that the administration “[doesn’t] yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure.” Some of those reports, he said, could easily have been triggered by an underlying medical condition or the use of other drugs. But, he added, “as a public health agency, it’s our job to communicate about potential safety concerns associated with the products we regulate.”This isn’t the first time seizures have been linked to nicotine poisoning. For years, medical literature has documented cases of nicotine-induced seizures—but those seizures were caused by the accidental or intentional ingestion of e-cigarette liquid, not by inhalation. There are a few ways that nicotine inhalation could cause seizures, the statement said. Different brands of e-cigarettes deliver varying doses of nicotine per puff. Juul, the dominant e-cig brand, for example, has been criticized for steadily ramping up the nicotine content of its pods, sparking what one report called a “nicotine arms race” among competitors. Gottlieb noted, however, that the 35 reported incidents between 2010 and 2019 weren’t specific enough to implicate any individual brand. “We noted today's FDA statement that since 2010 they have recorded 35 reports of seizures that mention e-cigarette use,” a spokesman for JUUL Labs said in an e-mailed statement to The Daily Beast. “We have robust safety monitoring systems in place and will vigilantly monitor for any evidence of safety issues and work cooperatively with FDA as we continue to combat youth usage and eliminate cigarettes, the number one cause of preventable death in the world.”The 35 reports are varied, involving both first-time users and seasoned smokers. Some seizures happened after just a few puffs, others happened up to a day after initial e-cig use. Some patients had a prior history of seizures, others reported using substances like marijuana or amphetamines, too. Seizures aren’t the only potential risk of e-cigarettes. Researchers have warned that e-cig use could be linked to damage in the heart, lungs, and brain. They can explode, too.Hours after the FDA statement, Gottlieb announced in a Twitter thread that the administration is also probing “clear evidence” that dangerous chemicals in tobacco smoke are also present “in the aerosol of some e-cig products.” “We know this exposure is a major health concern due to the ability of e-cig particles to penetrate deep into respiratory system. Some of the toxic chemicals and other substances contained in e-cigs can go deep into the lungs and may pose risk for diseases not seen in smokers,” Gottlieb wrote. He added said that e-cig vapors can cause decreased lung development, breathing difficulties, and vaping induced inflammatory reactions, and could induce cancer. By issuing the statement, Gottlieb said, the administration hoped to encourage users to report any similar events. “We need more information before we can determine if there’s in fact a link between e-cigarette use and the reported incidents,” he wrote. “It’s our hope that these public steps to solicit additional reports of adverse events, along with other agency efforts, will allow us to understand whether there’s a connection.” Read more at The Daily Beast.

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