EU English Parliment asks for adverse drug reaction counts to Vrenicline/NRT's./Ecig

[mountaingal]

[h=2]This was taken directly from planetofthevapes.co.uk


Another revealing answer from Parliament[/h]

MP David Davies is on a roll. He asked for a breakdown of the number of ADR (Adverse Drug Reactions) for ecigs, NRT and Varenicline (or Champix/Chantix)

The following table shows the total number of serious UK spontaneous ‘suspected’ ADR reports received by the MHRA between 23 July 2013 and 22 July 2014 broken down for E-Cigarettes, Nicotine Replacement Therapies (excluding E-Cigarettes) and Varenicline:


Total Serious Reports
Varenicline


297


Nicotine Replacement therapy


75


E-Cigarettes


5
​

So, only 5 ADR from ecigs? For the whole year? The FDA needs all the facts, from all the sources!

Taken from House of Commons:

[h=3]Smoking[/h]David T. C. Davies: To ask the Secretary of State for Health how many serious health events have been recorded per thousand (a) e-cigarette users, (b) users of nicotine replacement therapies and (c) users of the Champix form of varenicline in the last year. [206979]
Jane Ellison: Reports of ‘suspected’ adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme; the Yellow Card Scheme. The scheme collects ADR reports from across the whole United Kingdom and includes all medicines, including those from prescriptions, over-the-counter or general retail sales. Reports are also received for herbal medicines and other unlicensed medicines.
There is unknown and a variable level of under-reporting to the Yellow Card Scheme meaning that data collected cannot be used to calculate incidence, as such we cannot provide the number of serious health events per thousand. We are unable to calculate this incidence because neither the total number of reactions occurring in the population, nor the number of patients using the drug is known.
The following table shows the total number of serious UK spontaneous ‘suspected’ ADR reports received by the MHRA between 23 July 2013 and 22 July 2014 broken down for E-Cigarettes, Nicotine Replacement Therapies (excluding E-Cigarettes) and Varenicline:

	Total Serious Reports
Varenicline	297
Nicotine Replacement therapy	75
E-Cigarettes	5

 

[supertrunker]

5 per thousand users. But still fewer than the others.

T

 

[Nate760]

The United States cannot, ever, under any circumstances, ascribe credibility to something that originated in Europe, because that's the first step toward socialist tyranny.

At least that's what Reagan told me.

 

[Maytwin]

5 per thousand users. But still fewer than the others.

T

Smoking

David T. C. Davies: To ask the Secretary of State for Health how many serious health events have been recorded per thousand (a) e-cigarette users, (b) users of nicotine replacement therapies and (c) users of the Champix form of varenicline in the last year. [206979]
Jane Ellison: Reports of ‘suspected’ adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme; the Yellow Card Scheme. The scheme collects ADR reports from across the whole United Kingdom and includes all medicines, including those from prescriptions, over-the-counter or general retail sales. Reports are also received for herbal medicines and other unlicensed medicines.
There is unknown and a variable level of under-reporting to the Yellow Card Scheme meaning that data collected cannot be used to calculate incidence, as such we cannot provide the number of serious health events per thousand. We are unable to calculate this incidence because neither the total number of reactions occurring in the population, nor the number of patients using the drug is known.
The following table shows the total number of serious UK spontaneous ‘suspected’ ADR reports received by the MHRA between 23 July 2013 and 22 July 2014 broken down for E-Cigarettes, Nicotine Replacement Therapies (excluding E-Cigarettes) and Varenicline:
Total Serious Reports
Varenicline 297
Nicotine Replacement therapy 75
E-Cigarettes 5

The way I read it was that the MHRA couldn't calculate the events per thousand but that the figures shown were the total number of events - so 5 in total for e-cigarettes

 

[Nana Gail]

At least they seem to have the Guts to ask relevent questions! Now will they break down what the adverse reactions or incidents were? I'd like to know what Serious entails and includes!

 

[NorthOfAtlanta]

5 per thousand users. But still fewer than the others.

T

That is total reports not per 1000, the FDA has a similar program but I think congress would have as much luck getting the figures from the FDA has they did with the IRS e-mails.

 

[Bill Godshall]

It would be helpful to have a more authoritative source for this very important information (if true) than just a blog that requires an ID and password to access.

 

[Moonbogg]

The FDA will ignore this and release their own data suggesting that 900 out of 1000 people using e-cigs damn near died within the first 5 minutes of use.

 

[Maytwin]

It would be helpful to have a more authoritative source for this very important information (if true) than just a blog that requires an ID and password to access.

If you scroll about two-thirds of the way down this page you will see it there (House of Commons Hansard Written Answers) and it was also reported on this site so I'm pretty sure it's true.

 

[mountaingal]

It would be helpful to have a more authoritative source for this very important information (if true) than just a blog that requires an ID and password to access.

Here is the Parliment report. The ecig report (tobacco packaging) is almost 3/4's of the way down the page. Look for the box that contains the "total serious report" as in the original post here.

House of Commons Hansard Written Answers for 04 Sep 2014 (pt 0002)

I agree that autoritive sources are important. I am sorry I did not include it in the original post.

 

[rolygate]

I have also asked via an FOI how many UK varenicline deaths have occurred:

https://www.whatdotheyknow.com/request/varenicline_deaths/new

 

[YKruss]

I have also asked via an FOI how many UK varenicline deaths have occurred:

https://www.whatdotheyknow.com/request/varenicline_deaths/new

So, they supposed to reply on October 7th or 9th.

 

[SarahsHope]

it ok thanks

 

[Anjaffm]

well they did reply in the meantime, to Roly (same link)
Like: we do not have this, do ask the MHRA.

Sounds like the usual government runaround to me.

 

[rolygate]

An FOI Request to the MHRA gets:

An error has occurred in the application. Content Server is too busy to handle request.

Well that's a surprise.

 

[Anjaffm]

Yeah, about as surprising as hearing that there are corrupt politicians or that "Public Health" is in the pay of Big Pharma.