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Post by LosingMyBullishness on Oct 18, 2016 16:27:14 GMT -5
I have not seen it in the label. Where have endos like the one Laura is mentioning in her interview got this concern from? I recall that it was not in the original FDA specs.
Can someone direct me to a document?
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Post by sportsrancho on Oct 18, 2016 16:36:01 GMT -5
I have not seen it in the label. Where have endos like the one Laura is mentioning in her interview got this concern from? I recall that it was not in the original FDA specs. Can someone direct me to a document? Good question. The only two T2's that I know personally on Afrezza both smoke. Tom got them started by giving them samples of the kids Afrezza. And then they went and got scripts from their doctors up in OC. ( We never seem to hear about people who get scripts with no problem.) |
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Post by liane on Oct 18, 2016 17:03:17 GMT -5
It's straight from the label - Not recommended in people who smoke. That does not preclude it from being prescribed, just that a physician must weight the risk / benefit.
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Post by LosingMyBullishness on Oct 18, 2016 17:33:25 GMT -5
It's straight from the label - Not recommended in people who smoke. That does not preclude it from being prescribed, just that a physician must weight the risk / benefit. Thanks. My apologies. Does anyone know how they got to that warning? Where there any issues in the trial with people who smoke or has smoked? |
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Post by mannmade on Oct 18, 2016 17:35:24 GMT -5
Not that were statically significant. It is my understanding Mnkd may have asked for restrictions on smokers and people w history of lung disease to prevent potential law suits.
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Post by sayhey24 on Oct 18, 2016 17:55:54 GMT -5
It's straight from the label - Not recommended in people who smoke. That does not preclude it from being prescribed, just that a physician must weight the risk / benefit. Thanks. My apologies. Does anyone know how they got to that warning? Where there any issues in the trial with people who smoke or has smoked? It was a recommendation out of the Adcom. The FDA review group was anti-afrezza. The Adcom experts voted 31-1 and 14-0 for approval. There was a lot of discussion around the unknown potential of lung issues even though there is no evidence. As a bone to the FDA the experts thought such a recommendation would be prudent. |
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Post by rockstarrick on Oct 18, 2016 18:32:46 GMT -5
Correction on the adcom vote, I believe it was,
13 yes and 1 no for type 1 and
14 yes and 0 no for type 2
A unanimous adcom, what a great day that was, we need a few more just like that one.
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Post by letitride on Oct 18, 2016 19:36:16 GMT -5
As someone who smoked heavily and stopped about anything would set off bronchial spasms for the first year or two after I quit so I can fully understand that part of the warning. It was never life threatening but it was sure as hell uncomfortable.
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Post by brentie on Oct 18, 2016 21:51:25 GMT -5
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