Our Win at the FDA hearing on Fluoroquinolone Antibiotics

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. :-( [ 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; A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS).

This is a win for the people over Big Farma given the constraints of the day.


http://www.newsnet5.com/news/local-news/investigations/levaquin-fda-fails-to-disclose-additional-serious-side-effects-of-antibiotic-linked-to-deaths is my Cleveland/Akron TV interview. 3,000 dead. 200,000 injured by these drugs per the FDA. That is estimated to be only one-percent of the real numbers!


“The panel voted overwhelmingly that the benefits and risks for the systemic fluoroquinolone antibacterial drugs do not support the current labeled indications for the treatment of ABS (unanimous), ABECB-COPD (2 yes, 18 no, 1 abstention), or uncomplicated urinary tract infection (1 yes, 20 no). Fluoroquinolones currently approved for one or more of these illnesses are ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, and gemifloxacin.” ~Troy Brown, RN

“Testimonies from patients who described the wide range of harmful side effects have spurred the FDA into action.” ~Alyssa Navarro

“Fluoroquinolone labels need much stronger warnings about the risks for serious adverse events, including tendinitis and tendon rupture, and peripheral neuropathy, the panel said. Fluoroquinolones currently approved for one or more of these illnesses are ciprofloxacin, levofloxacin, ofloxacin, and gemifloxacin. In India, popular brands of fluoroquinolones include Ciplox, Ciprobid, Levoflox and Oflox.” ~Rupali Mukherjee


Acute Bacterial Sinusitis - Antibacterial Efficacy:

  • [FDA] reviewed 20 placebo controlled trials published in the medical literature (see bibliography in Appendix A). Fourteen studies did not show a statistically significant difference over placebo.

Acute Exacerbations of Chronic Bronchitis - Antibacterial Efficacy:

  • [FDA] reviewed 15 placebo controlled studies of ABECB COPD (see bibliography in Appendix A). Nine studies did not show a difference in clinical outcomes between patients who received placebo and patients who received an antibacterial drug. Six studies showed a statistically significant difference in favor of an antibacterial drug, although the studies enrolled patients with varying disease severity and used different outcome assessments…

Uncomplicated Urinary Tract Infection - Antibacterial Efficacy:

  • There is a clear and consistent treatment effect of antibacterial drug therapy for treatment of uUTI on the outcome assessment of microbiologic eradication. In studies that used a placebo control, there is a similar treatment effect using an outcome assessment based on symptom resolution. In a study that used ibuprofen as a control, there was no treatment difference on symptom resolution in comparison to an antibacterial drug.

Additionally, in the meeting brief and this 617 page PDF, the FDA identified a syndrome associated with fluoroquinolone toxicity—one that “floxies” have been pushing for recognition of for years. It is called Fluoroquinolone Associated Disability (FQAD). According to the FDA:

“While most of the individual AEs (adverse events) that exist within FQAD (fluoroquinolone associated disability) are currently described in fluoroquinolone labeling, the particular constellation of symptoms across organ systems is not. Individuals with FQAD were defined as U.S. patients who were reported to be previously healthy and prescribed an oral fluoroquinolone antibacterial drug for the treatment of uncomplicated sinusitis, bronchitis, or urinary tract infection (UTI). To qualify, individuals had to have AEs reported in two or more of the following body systems: peripheral nervous system, neuropsychiatric, musculoskeletal, senses, cardiovascular and skin. These body systems were chosen as they had been observed to be frequently involved with the fluoroquinolone reports describing disability. In addition, the AEs had to have been reported to last 30 days or longer after stopping the fluoroquinolone, and had to have a reported outcome of disability.”

See http://www.hormonesmatter.com/victory-at-the-fda-for-fluoroquinolone-victims/ for a detailed summary.


The FDA has posted the videos of the November 5th 2015 Fluoroquinolone Antibiotics hearing.

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. The last two are the most interesting:

• Start of Meeting to Morning Break: https://collaboration.fda.gov/p28guhbz4py/ [Introduction.]

• 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/ [Victims give their stories.]

• 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:

https://collaboration.fda.gov/common/help/en/support/meeting_test.htm

If having problems viewing things, like the FDA Flash Video, on a phone try the Puffin Browser:

http://www.puffinbrowser.com/index.php

See http://floxiehope.com/fluoroquinolones-links-resources/ for resources and links to the 150 TV News Videos.

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