Adverse events reported to FDA showing significant declines

[otherottawaguy]

Post on Investor Village (quiet board for MNK)

Re: Nobody Appears To Be Listening to the Users of Afrezza

Here is the FDA site that tracks reported issues for all drugs:

www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm070093.htm


Afrezza specific:

fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/45beeb74-30ab-46be-8267-5756582633b4/state/analysis



Looks as if reported adverse effects has significantly dropped, could it be better patient education?



OOG

[otherottawaguy]

Sorry, second link does not seem to work. You will need to accept the disclaimer and then provide the drug name "Afrezza".

You can also see the causes of the reported incident and other demographics by the dropdown on the top right.

OOG

[otherottawaguy]

Wow you got that one off topic for two pages.

See Trepostinil topic if you want to continue its discussion.

OOG

[MnkdWASmyRtrmntPlan]

First, it is great to see that dramatic down-turn.  But, 3 deaths?  I'm sure it has been discussed before, but 22 Serious effects and 3 deaths!? 3 deaths! I guess that is when someone passes and they have to report all the meds they were on at the time? Is that it? And the 22 serious are probably hypos that were actually caused by their basal.

I guess its not so bad. 

Humalog has 17,410 serious and 837 deaths.  Number of cases down from 2017 = 4612 - 9.87%  to 2018 = 2141 - 4.58%
Novolog 4,478 serious and 155 deaths.  2017 = 1293 - 16.86% to 2018 = 483 - 6.3%
Apidra 1,746 serious and 164 deaths.    2017 = 129 - 5.06%  to 2018 = 136 - 5.33%

So, Humalog is down to half from last year, Novolog is down to almost a third of last year, and only Apidra actually has more this year than last.  Remember, this year's numbers are just Year to Date.  But, still, compare those to Afrezza:

Afrezza 22 serious, 3 deaths, 2017 = 54 - 14.67%  and  2018 = 2 - .54%
So, OOG, you have a good point.  And with our (modest) increase in sales, that's good news.

[porkini]

Aug 31, 2018 9:16:05 GMT -5 MnkdWASmyRtrmntPlan said:

First, it is great to see that dramatic down-turn.  But, 3 deaths?  I'm sure it has been discussed before, but 22 Serious effects and 3 deaths!? 3 deaths! I guess that is when someone passes and they have to report all the meds they were on at the time? Is that it? And the 22 serious are probably hypos that were actually caused by their basal.

I guess its not so bad. 

Humalog has 17,410 serious and 837 deaths.  Number of cases down from 2017 = 4612 - 9.87%  to 2018 = 2141 - 4.58%
Novolog 4,478 serious and 155 deaths.  2017 = 1293 - 16.86% to 2018 = 483 - 6.3%
Apidra 1,746 serious and 164 deaths.    2017 = 129 - 5.06%  to 2018 = 136 - 5.33%

So, Humalog is down to half from last year, Novolog is down to almost a third of last year, and only Apidra actually has more this year than last.  Remember, this year's numbers are just Year to Date.  But, still, compare those to Afrezza:

Afrezza 22 serious, 3 deaths, 2017 = 54 - 14.67%  and  2018 = 2 - .54%
So, OOG, you have a good point.  And with our (modest) increase in sales, that's good news.

Tried to dig around a little but have run out of time... 
(tried a link, did not work, have to use the original link above and navigate on your own)
If you look at Reaction Group and select the categories, you will find that:
2 of those are under the Reaction Group of "General Disorders And Administration Site Conditions"
1 of those is under the Reaction Group of "Gastrointestinal Disorders"

So, my guess is that this gets reported for all meds taken and then the incident gets reported to all products the patient is on without regard to whether any one of them is actually responsible for the event.