ADA forum entry about Exubera clinical trial death from hypo

[sluggobear]

I am working on a project which involves pancreatic islet transplants (I'm a consultant) and went to the American Diabetes Association website to look for basic information and statistics. Since I am now obsessed with Afrezza and Mannkind...instead of working I went to peruse the forums for Afrezza. I found this entry below. This is a serious disease and ALL insulin needs to be safe! This story is a bummer but the need for LESS HYPOS is important!

From the "I Love Someone With Diabetes" forum, I searched for Afrezza and found this entry:

chknj        Occasional Visitor
Total Posts: 2
Registered on: ‎07-06-2014

Inhaled Insulin needs more info about combining doses with long-acting insulin

‎07-06-2014 11:59 AM

I just learned that Afrezza inhaled insulin was approved by the FDA, and read the prescribing information and patient medication guide. There is practically no information about how to combine the use of Afrezza at meals with long acting insulin. The literature directs patients to see their doctor, but I could find no clear direction for the doctors, either. MAKE SURE YOU KNOW HOW TO COMBINE THE 2 DOSAGE FORMS or it could lead to your death. The Afrezza product information notes the following "serious adverse reactions which are described elsewhere in the labeling:

• Acute bronchospasm in patients with chronic lung disease [see Warnings and
Precautions (5.1)]
• Hypoglycemia [see Warnings and Precautions (5.3)]
• Decline in pulmonary function [see Warnings and Precautions (5.4)]
• Lung cancer [see Warnings and Precautions (5.5)]
• Diabetic ketoacidosis [see Warnings and Precautions (5.6)]
• Hypersensitivity reactions [see Warnings and Precautions (5.7)]

In warnings and precautions it states "Severe hypoglycemia can cause seizures, may be life-threatening, or cause death."

My brother was in the Exubera clinical study, and after inhaling Exubera during the day and taking his long-action insulin before bedtime he experienced severe hypoglycemia, had a seizure, and died. He enrolled in the clinical trial because he was committed to improving the quality of life for people with Type 1 diabetes. The clinical trial information he got about the study said death was a possible side effect of Exubera, but the final literature approved by the FDA did not list death as a side effect; it used very tricky wording and cited him as one of 3 "patients withdrawn from the clinical trial because of death."

My brother was only 49 when he died after combining inhaled insulin with long-acting insulin. Don't let it happen to you.

CHKNJ

[suebeeee1]

Afrezza is short acting and clears fast. Even with using long acting insulin or even a pump and inhaling and NOT eating, none of the online cgm users that have demonstrated AFrezza have gone into a dangerous hypoglycemia. We have not had any problems with hypoglycemia even though my husband is a newbie and doesn't test his blood often.

Afrezza is super super fast so the risk is far less. Nice that CHKNJ is worried about all the Afrezza users, but if s/he had a clue or actually did any research, s/he would realize it isn't much of a possibility. Could happen, but so could a hypo with any insulin. But it happens less with Afrezza!

[liane]

sluggobear,

You really need to provide a direct link. I searched for a couple minutes (don't have more time) and could not come up with the same forum you mentioned. I don't mind you posting about this, but it's helpful to have the entire context.

Exubera is not Afrezza; their insulin is not monomers. The onset and duration of action is likely longer, and thus a higher possibility of hypos.

[benh]

Red Flag page: community.diabetes.org/t5/user/viewprofilepage/user-id/245542

See - Registered, Last logged in and posts.

[liane]

So this chknj registered and posted the same thing twice within the span of a day or two and hasn't been heard from since. No replies to his post - so no further context. Sounds like bash and run. He's bashing Afrezza by so-called association with Exubera.

[mindovermatter]

I think some on here would call this post FUD. This time, I'd agree with them. I have no idea why this poster would post this at this time as it has absolutely nothing to do with Afrezza, Afrezza has been on the market for a year with no reported issues of hypos (if anything, it has drastically reduced them for many) AND it is one anecdotal story with no substantiation at all. Besides, hypos are a common side effect for ALL diabetics who take insulin. Nothing new to see here. Please move on.

[mindovermatter]

Feb 12, 2016 7:05:22 GMT -5 liane said:

So this chknj registered and posted the same thing twice within the span of a day or two and hasn't been heard from since. No replies to his post - so no further context. Sounds like bash and run. He's bashing Afrezza by so-called association with Exubera.

Was going to reference that in my post. Again, not sure why the OP felt the need to post this at this time, a year AFTER Afrezza was officially available to be prescribed. Hate to say it but his post is a great example of FUD that was poorly executed.

[jerrys]

I find it more disconcerting that there appear to have been no comments about afrezza since april 4 of 2015. On the ADA forum?

[dreamboatcruise]

Of course insulin overdose can cause death. Sure hope there isn't any PWD that isn't fully aware of that.

I agree on FUDness of that post as it seems to imply that only inhaled insulin has this problem... which is utter nonsense.

It's a real issue, and we have the data showing Afrezza is better than the alternatives regarding hypos.

[mbracket123]

Liane, no Symphony numbers today?

[liane]

Haven't heard a word

[sluggobear]

Feb 12, 2016 5:53:04 GMT -5 liane said:

sluggobear ,

You really need to provide a direct link. I searched for a couple minutes (don't have more time) and could not come up with the same forum you mentioned. I don't mind you posting about this, but it's helpful to have the entire context.

Exubera is not Afrezza; their insulin is not monomers. The onset and duration of action is likely longer, and thus a higher possibility of hypos.

Sorry liane - I rushed in posting that ADA forum entry because I was trying to get some work done last night. I do try to post links when I think the information is important. This was just a blog entry.

community.diabetes.org/t5/forums/searchpage/tab/message?filter=labels%2Clocation&location=forum-board%3Acaregivers&q=Afrezza
 
Context: Maybe this clinical trial death was old news to those who know more about Exubera but I was shocked that someone (might have*) DIED in the Exubera clinical trial from a hypo. (*I never considered that the poster was not genuine. It is far-fetched that someone would go to the trouble of posting something like that in an obscure ADA post for FUD or other devious reasons.)

My post was NOT a knock against Afrezza either and I don't see how someone would have got that my OP. In fact, the opposite was implied because I assume that everyone here knows that Afrezza is a much better product than Exubera and hopefully, if miracles come to pass, there will be clinical data for Afrezza (suitable for claims) that shows statistically significant decreases in potentially dangerous hypoglycemic episodes.

The primary point that I saw in the ADA post from "chknj" that I thought was important:
"There is practically no information about how to combine the use of Afrezza at meals with long acting insulin."

Read more: mnkd.proboards.com/post/62189/quote/5174?page=1#ixzz3zzgFVgjy

I think I was just being overly "Exuberant" in my posting last night...

[liane]

sluggobear,

I didn't think you were trying to knock Afrezza. I don't know if the blog post is legit or not - just seems suspicious. I like to enforce the requirement to post links - I don't like to spend more than a minute or two verifying a post.

Carry On!