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Post by dreamontrader on Nov 30, 2018 21:19:36 GMT -5
If you are type 1 & pregnant, is it safe to take afrezza?
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Post by agedhippie on Nov 30, 2018 21:49:26 GMT -5
If you are type 1 & pregnant, is it safe to take afrezza? Technically I would expect it is, however it has not been studied so the label will not say that it is safe. The label says "... AFREZZA may harm your unborn or breastfeeding baby...". Note that it is a may rather than a will. What you are seeing is the FDA saying that at this point nobody knows. |
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Post by uvula on Dec 1, 2018 1:40:58 GMT -5
If an afrezza user becomes pregnant does she have to switch insulin? Or does the doctor make the decision? Would the doctor have some liability if something bad happens? Have any insulins had clinical trials for this?
I can't see how any insulin would be inherently bad for pregnant women or their babies.
Wouldn't afrezza be an advantage over injecting into a stretched abdomen?
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Post by mnholdem on Dec 1, 2018 8:20:48 GMT -5
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Limited available data with AFREZZA use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. Available information from published studies with human insulin use during pregnancy has not reported a clear association with human insulin and adverse developmental outcomes (see Data). Source: www.afrezza.com/pdf/Promo-Label-US-AFR-0526-PI-MedGuide-IFU-20181113.pdf |
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Post by agedhippie on Dec 1, 2018 12:17:02 GMT -5
If an afrezza user becomes pregnant does she have to switch insulin? Or does the doctor make the decision? Would the doctor have some liability if something bad happens? Have any insulins had clinical trials for this? I can't see how any insulin would be inherently bad for pregnant women or their babies. Wouldn't afrezza be an advantage over injecting into a stretched abdomen? |
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Post by joeypotsandpans on Dec 1, 2018 21:57:19 GMT -5
If you are type 1 & pregnant, is it safe to take afrezza? According to Adcomm testimonial speaker #3 Anna Ortiz (around the 8:30 mark) who is T1 and was pregnant during the trial, she is a believer and testified how it made her life easier. youtu.be/ylin1ZSDo0o |
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Post by agedhippie on Dec 2, 2018 10:44:14 GMT -5
If you are type 1 & pregnant, is it safe to take afrezza? According to Adcomm testimonial speaker #3 Anna Ortiz (around the 8:30 mark) who is T1 and was pregnant during the trial, she is a believer and testified how it made her life easier. youtu.be/ylin1ZSDo0o... and balanced against that you are going to have a doctor saying that the FDA says there is insufficient data and that it may harm your unborn or breastfeeding baby. The mother is very vulnerable at this point, which way do you think she jumps, play safe and the status quo, or swap insulins with even a vague risk of harm to the baby and possibly have better control? My bet is the former but it's rather obviously outside my experience. A better approach is to swap as part of the preparation for becoming pregnant when you have time to titrate the doses and experiment. Endos like you to have nice low stable numbers for a minimum of three months, and ideal six months, before conception. That is the time to swap, once you are pregnant it is far more problematic. |
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