FDA 136 times more Adverse Events reported to FDA for NRT products than for e-cigs

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Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
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136 times more Adverse Events were reported to FDA for FDA approved nicotine gums, lozenges, patches & nasal sprays than for e-cigs (3,819 vs 28) from 2007-2014.

Brad Rodu: Scaremongering tactics against smoke-free tobacco could also undermine nicotine medicines
Tobacco Truth: Scaremongering Tactics Against Smoke-Free Tobacco Could Also Undermine Nicotine Medicines

But of course, not one report or press release about this huge discrepency from any e-cig prohibitionists at FDA, CDC or other DHHS agencies, nor from anyone funded by DHHS or Big Pharma to demonize e-cigs, nor from anyone who has urged FDA to ban e-cigs (i.e. via the deeming reg).
 

Endor

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@Bill Godshall - I often read the studies and reports you post, but I just wanted to say I am always thankful for what you do for our cause.

May truth set us free (and may the truth BE set free!)

I'd like to +1 that as well. I'm glad to you have you on our side, Bill.

This is a very interesting study, however, I remain a bit cautious as to the usefulness (or accuracy).

Pharmaceutical companies are required to have adverse event reporting processes, and to report those adverse events regularly to the FDA. Since e-cigs are not under FDA control, no such mandate exists in that world. Hence, the numbers for e-cig adverse events would likely be lower than they would for pharmaceutical products, simply because users don't know a) they can report them, and b) who to report them to.

EDIT: But, that being said, it is still interesting that so many adverse events are reported for pharmaceutical NRTs. It does fly in the face of the "only FDA approved NRTs are safe for smoking cessation" rhetoric.
 

Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
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Apr 2, 2009
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The FDA announced a reporting system for adverse events for e-cigs 6 years ago when the agency began its War on vaping (after it unlawfully banned the import of e-cigs).

FDA Warns of Health Risks Posed by E-Cigarettes
"Meanwhile, health care professionals and consumers may report serious adverse events or product quality problems with the use of e-cigarettes to FDA through the MedWatch program, either online or by phone at 1-800-FDA-1088."
 
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