Advocacy Opportunity - FDA Meeting to Discuss Fluoroquinolones

ADVOCACY OPPORTUNITY

The FDA (Food and Drug Administration) is holding a meeting on November 5, 2015 to discuss the benefits and risks of fluoroquinolones. Per the FDA notice, the agenda for the meeting is:

“The committees will discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.”

They are opening the meeting for public testimony and if you are in the Silver Spring, Maryland area I encourage you to attend the meeting and to testify at it. (I would love to go, but I’m in Colorado, so not exactly nearby.)

They are also accepting written testimony. Please send your story/testimony to Jennifer Shepherd, the contact person, by October 22, 2015. Jennifer’s contact information is:

Jennifer Shepherd, RPh.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 301-796-9001
Fax: 301-847-8533
E-mail: AMDAC@fda.hhs.gov

PLEASE take the time to tell your story to the FDA. The adverse effects of fluoroquinolones are too severe for it to be appropriate for them to be used for sinusitis or uncomplicated urinary tract infections. This is your opportunity to share your story directly with the FDA, and the committee that determines how fluoroquinolones are used.

More information can be found in these announcement links –

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm465275.htm

https://www.federalregister.gov/articles/2015/10/01/2015-24836/joint-meeting-of-the-antimicrobial-drugs-advisory-committee-formerly-known-as-the-anti-infective

THANK YOU!!!

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9 years ago

Thank you Lisa. I will most definitely write!!! (Is this also posted on FLQ wall of pain and other sites?)

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Bonnie Jacobus

Lisa, I don’t know if I had an “uncomplicated” uti to give my experience. What does that mean especially when you suffered from fq? Bonnie

Just finished a three page letter (four if you count the lovely before/after pics). I also want to mention I think it is important to assert that our reactions are NOT rare, and we didn’t just have an allergic response, but that in fact ALL people at some point will react. Also remember the figures re after market reports. The FDA received reports of 3,000 deaths and 50,000 side effects, which, since only about 1% report, extrapolates out to a possible 300,000 deaths and millions of side effects. I wish I could go and speak in person. I hope that FINALLY they listen. And I mean, come on, if they are talking about risk/benefit, just LIMIT the damn things to life and death situations!

Lara

I have a friend (no, really) who has been experiencing facial nerve pain for 6-8 months, as well as many other symptoms. The nerve pain is so bad that she can’t be around electronics, from cell phones to major appliances. She had been on many FQs for years to treat chronic UTIs, and most recently, sinus infections, and sinus surgery. Could this facial nerve pain be a consequence of FQ poisoning? It’s past the Oct 22 deadline for submitting her story. Are any submissions still being taken?