Official FDA Adverse Events Associated with Afrezza

[mango]

This is a report of the Adverse Events associated with Afrezza obtained from the FDA via FOIA request.

• A total of 347 individual patient case reports have been associated with Afrezza ending May 20th, 2017.

• 9 total adverse events associated with bronchospasm.

[uvula]

Thanks for posting this.
Blood glucose increased? Really?
Blood glucose decreased? Is this a bad thing?
3 deaths?
The percentage of cases seems like a weird metric. It doesn't include the total number of people using Afrezza. It just looks at the number of case reports.

Maybe we can take up a collection to come up with the $60 needed for the detailed report.

[boytroy88]

May 28, 2017 19:08:48 GMT -5 uvula said:

Thanks for posting this.
Blood glucose increased? Really?
Blood glucose decreased? Is this a bad thing?
3 deaths?
The percentage of cases seems like a weird metric. It doesn't include the total number of people using Afrezza. It just looks at the number of case reports.

Maybe we can take up a collection to come up with the $60 needed for the detailed report.

NM

[mnholdem]

uvula  I suggest that you read the footnotes. The FDA states that death may be an "outcome" (patients die of diabetes all the time, unfortunately with this disease) that sometimes are erroneously recorded as an "event". The deaths may not be directly attributed to a patient's use of Afrezza.

[boytroy88]

May 28, 2017 19:42:20 GMT -5 mnholdem said:

I suggest that you read the footnotes. The FDA states that death Is often an "outcome" (patients die of diabetes all the time, unfortunately with this disease) but deaths may sometimes be erroneously recorded as an "event". These deaths can be outcomes that are not directly attributed to a patient's use of Afrezza.

Yep...just noticed it and was in the process of "wiping" out my comment...

[mango]

May 28, 2017 19:08:48 GMT -5 uvula said:

Thanks for posting this.
Blood glucose increased? Really?
Blood glucose decreased? Is this a bad thing?
3 deaths?
The percentage of cases seems like a weird metric. It doesn't include the total number of people using Afrezza. It just looks at the number of case reports.

Maybe we can take up a collection to come up with the $60 needed for the detailed report.

If there is enough interest, I will request a detailed report. Personally, I think this holds its on weight. Some of these would have Afrezza listed as a Secondary Suspect or as a Concomitant. So not every Adverse Event necessarily has Afrezza listed as Primary Suspect.

• For example, all of the adverse events associated with the word injection would obviously not have Afrezza listed as the Primary Suspect.

• The three deaths are these:



• I personally think there is nothing to worry about. Only 347 individual patient reports are associated with the use of Afrezza. I think all the black box warnings should be removed based off this data, but I do not know if the FDA has ever done that using solely this data, however, no case studies have been published post-approval about a patient developing bronchospasms or non-reversable FEV1s or developing lung cancer or amyloidosis specifically from Afrezza either. So...seems unbelievably safe. This is everything reported since approval.

• More than likely there are other meds listed that contributed to the increased/decreased blood glucose.


• Meanwhile...

FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)

[ 5-16-2017 ] Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

www.fda.gov/Drugs/DrugSafety/ucm557507.htm

[myocat]

Thanks for shooting.
I think those are established events recording during and after FDA approval. All developed and approved drugs would have a long laundry list of adverse events.

Did you Know skin rash associated with wearing the CGM is an adverse event?

[mango]

May 28, 2017 21:19:17 GMT -5 myocat said:

Thanks for shooting.
I think those are established events recording during and after FDA approval. All developed and approved drugs would have a long laundry list of adverse events.

Did you Know skin rash associated with wearing the CGM is an adverse event?

They are from January 1st, 2014—May 20th, 2017. Second pic in OP under FDA Received Date.

[brotherm1]

good stuff. Thank you Forresttrees

[boomboom]

I am drooling because there is nothing like concrete data to help make a sound decision!

I would suggest we all contribute to get the detailed reports but not just for Afrezza. I would suggest we get detailed reports on...

1. Exubera (similar drug but failed for obvious reasons. Still good to know where they stood with results)
2. Another popular and widely used RAA
3. Afrezza

It would be nice to see where our percentage breakdowns are and how we compare to current widely used RAAs.

[brotherm1]

we saw some of that recently for other insulins boomboom. It's nasty.

[boomboom]

Thanks brotherm1. Was the data presented as shown above? Is Afrezzas spread similar or different to the current RAAs?

[mango]

May 29, 2017 0:54:59 GMT -5 boomboom said:

Thanks brotherm1. Was the data presented as shown above? Is Afrezzas spread similar or different to the current RAAs?

All the RAAs have a dangerous profile. Same with the first line T2D treatment, Metformin.