blog:bpaddock:win_at_the_fda_hearing_on_fluoroquinolone_antibiotics

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blog:bpaddock:win_at_the_fda_hearing_on_fluoroquinolone_antibiotics [2015/11/17 01:29]
bpaddock created		blog:bpaddock:win_at_the_fda_hearing_on_fluoroquinolone_antibiotics [2016/03/22 00:01] (current)
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 The nearly unanimous conclusion of the FDA advisory panel states that the current labelling to support Fluoroquinolone antibiotics use for sinusitis, bronchitis and uUTI is NOT justified. The nearly unanimous conclusion of the FDA advisory panel states that the current labelling to support Fluoroquinolone antibiotics use for sinusitis, bronchitis and uUTI is NOT justified.
  
-Eyes and Ears where not considered. In the opening remarks the FDA Chair said that //detached retinas due to these drugs would not be considered// today [Nov 5th 2015].  //When// will they?  How many people think about how taking an antibiotic will make them go blind. :-(+Eyes and Ears where not considered. In the opening remarks the FDA Chair said that //detached retinas due to these drugs would not be considered// today [Nov 5th 2015].  //When// will they?  How many people think about how taking an antibiotic will make them go blind. :-(  [ New paper just published about FQ's being linked to Retinal Detachment:  http://medicalresearch.com/ophthalmology/fluoroquinolones-linked-to-increase-in-retinal-detachments/22538/ Paywall version of the actual report: http://archopht.jamanetwork.com/article.aspx?articleid=2499851 ]
  
 Note: The advisory committee made its recommendations, but now that has be evaluated by the FDA itself do decide what to do. They could decide to do nothing at all (not likely due to all the press there), take it off the market (what I want but not likely), change the labels, or the last option is require the patient to sign off that they understand the devastating effects before taking any of these drugs; [[http://www.fda.gov/AboutFDA/Transparency/Basics/ucm325201.htm|A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS)]]. Note: The advisory committee made its recommendations, but now that has be evaluated by the FDA itself do decide what to do. They could decide to do nothing at all (not likely due to all the press there), take it off the market (what I want but not likely), change the labels, or the last option is require the patient to sign off that they understand the devastating effects before taking any of these drugs; [[http://www.fda.gov/AboutFDA/Transparency/Basics/ucm325201.htm|A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS)]].
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 The Center for Drug Evaluation and Research (CDER) provided a live webcast of the November 5, 2015, joint meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The Center for Drug Evaluation and Research (CDER) provided a live webcast of the November 5, 2015, joint meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
  
-A recording of the webcast can be found at the following address:+A recording of the webcast can be found at the following address.  The last two are the most interesting:
  
-• Start of Meeting to Morning Break: https://collaboration.fda.gov/p28guhbz4py/+• Start of Meeting to Morning Break: https://collaboration.fda.gov/p28guhbz4py/ [Introduction.]
  
-• Morning Break to Lunch Break: https://collaboration.fda.gov/p4r7n9ab271/+• Morning Break to Lunch Break: https://collaboration.fda.gov/p4r7n9ab271/ [Big Farma fails to convince anyone.]
  
-• Lunch Break to Afternoon Break: https://collaboration.fda.gov/p7q9g54ygww/+• Lunch Break to Afternoon Break: https://collaboration.fda.gov/p7q9g54ygww/ [Victims give their stories.]
  
-• Afternoon Break to End of Meeting: https://collaboration.fda.gov/p644nkzdcva/+• Afternoon Break to End of Meeting: https://collaboration.fda.gov/p644nkzdcva/ [The panel vote.]
  
 The webcast was broadcast using Adobe Connect. You can make sure your computer has the correct plug-ins to view the webcast at this web site: The webcast was broadcast using Adobe Connect. You can make sure your computer has the correct plug-ins to view the webcast at this web site:
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-http://floxiehope.com/fluoroquinolones-links-resources/+See http://floxiehope.com/fluoroquinolones-links-resources/ for resources and links to the 150 TV News Videos.
  
 {{tag>FDAQ Floxie Fluoroquinolone Antibiotics Detached Retinas FDA Ruptured Tendon Golf}} {{tag>FDAQ Floxie Fluoroquinolone Antibiotics Detached Retinas FDA Ruptured Tendon Golf}}
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