On June 8m 2014 a petition was filed by Dr. Charles Bennett requesting professional label changes to the label for fluoroquinolone antibiotics. You can read the petition here. These label changes would reflect the possibility that the fluoroquinolone class of antibiotics could cause mitochondrial toxicity in patients.
The FDA has responded stating that they “have been unable to reach a decision…because it raises complex issues requiring extensive review and analysis by Agency officials.” They have been considering these “complex issues” for almost 8 months and yet no progress has occurred. You can read the FDA’s response here. The FDA has known, though its own internal review process, that fluoroquinolone antibiotics can cause permanent peripheral neuropathy in healthy individuals, and that the method of action for this damage is suspected to be mitochondrial toxicity (1). The FDA has been derelict in their duty to fully warn the general public of the dangers these drugs pose to the general public.
The community is asking that each person notify the FDA telling them you support the citizen’s petition Docket #FDA-2014-P-0856. I encourage each person, their family, and friends please write the FDA in support of this effort. I have made available an editable letter in Word format that you may download edit and send in. (Download it here).
The current acting commissioner is:
Dr. Stephen Ostroff