The FDA new regulations cover vaping products dating back to 2006.
This is kinda funny because 2006 is the same year Pfizer came out with their stop smoking drug Chantix (Varenicline)
Below is from The Institute for Safe Medication Practices (ISMP) a non-profit medication watchdog.
Strong Signal Seen on New Varenicline Risks
The FDA approved varenicline in May 2006
In the 4th quarter of 2007 varenicline accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period.
Accidents and injuries. A total of 173 serious events described accidental injury, including 28 road traffic accidents and 77 falls, some leading to fractures of rib, facial bones, hand, ankle, spine, and lower limbs. In these cases a variety of potential causes were identified, including loss of consciousness, mental confusion, dizziness and muscle spasms.
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Vision disturbance. At least 148 reports contained medical terms indicating vision disturbances, including 68 cases described as blurred vision and 26 terms indicating transient or other forms of blindness. This reported effect could also describe a mechanism that could or did contribute to accidents and injuries.
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Heart rhythm disturbances. The FDA received 224 domestic reports classified as potential cardiac rhythm disturbances. This category, however, was dominated by reports of sudden loss of consciousness, an event that could also have non-cardiac causes. However, this category also included smaller numbers of cardiac arrests and identifiable abnormal cardiac rhythms
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Seizures and abnormal muscle spasms or movements. Serious reported events included 86 cases of convulsions (seizures), 372 reports of a wide variety of movement disorders, including tremors, muscle spasms, twitching, tics, drooling, and motor hyperactivity. The extent to which these problems resolved with a reduced dose or by halting treatment could not be determined from these data.
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Moderate and severe skin reactions. Reported serious events included 338 cases of hives or swelling of the tongue, face, eyes, lips or other areas. In addition, 65 cases were classified as severe and included blisters, exfoliation of the skin and lips, and Stevens-Johnson Syndrome.
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Diabetes. The FDA has received 544 reports suggesting varenicline may be related to a loss of glycemic control. This category included many cases of weight loss or gain that could have alternative causes, but also identified numerous cases of symptoms and laboratory tests consistent with new onset diabetes.
And that was in just the first year of Chantix
In 2009 the FDA made Pfizer put a Black-Box Warning on Chantix, which is the strictest
warning put on the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA)
Only took them 2 years to do this.
2010 report on Thoughts and acts of aggression/violence toward others reported in association with varenicline
Thoughts and acts of aggression/violence toward others reported in association with varenicline. - PubMed - NCBI
Which analyzed 26 acts of Violence reported to the FDA as side effects of Chantix.
The study called them “inexplicable and unprovoked":
“A woman struck her 17-year-old daughter in the mouth while the daughter was driving a car…
A 42-year-old man punched a stranger at a bowling alley...
A 24-year-old started beating her boyfriend in bed because ‘he looked so peaceful’ and she later attempted suicide.”
In 2011 Pfizer updated the Black-Box Warning label.
By 2013 Chantix was linked to more than 500 suicides
FDA: Anti-smoking drug Chantix linked to more than 500 suicides
2014-2015
A Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM)
Briefing Information for the October 16, 2014 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM)
The FDA Drug Safety Communication: FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking.
FDA Drug Safety Communication: FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking
Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events.
FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events
The
FDA has asked Pfizer to investigate reports of violence by Chantix users and report back by 2017.
2016 - Pfizer has been lobbying the FDA to back off of the black-box warning on its stop-smoking drug Chantix, whose sales hit $647 million worldwide last year, $377 million of that in the U.S.
BUT WE HAVE TO SAVE THE CHILDREN FROM VAPING