FDA has failed to act on two Fluoroquinolone related Citizens’ petition submitted by Dr. Bennett and The Southern Network on Adverse Reactions (SONAR). 
Citizen Petition to the FDA in June, 2014 (Docket #FDA-2014-P-0856) asking for warnings to be placed on the Levaquin label regarding possible Mitochondrial Toxicity.
Citizen Petition to the FDA in September, 2014 (Docket #FDA-2014-P-1611) asking for additional warnings to be placed on the Levaquin label regarding about possible Psychiatric adverse events.
Using the same wording on both, The FDA, is using a delaying tactic stating it basically has to review and analyze its own data and information. This is ridiculous! You can read about the refusals and read the FDA’s response letter here.
Take Action
What can you do? We must not let the FDA drop the ball and dismiss these legitimate 
serious concerns. For now we are asking everyone to email Dr. Margaret Hamburg, and her replacement Dr. Stephen Ostroff, at the following email addresses:
Dr. Margaret Hamburg – margaret.hamburg@fda.hhs.gov
Dr. Stephen Ostroff – stephen.ostroff@fda.hhs.gov
You can copy the following letter to use in your own email or you can download this letter in Microsoft Word format by clicking here.
#FDAFail
Begin Letter:
Dear Dr. Hamburg and Dr. Ostroff:
Levaquin Mitochondrial Toxicity Citizen Petition
Dr. Charles Bennett and The Southern Network on Adverse Reactions (SONAR) submitted a Citizen Petition to the FDA in June, 2014 (Docket #FDA-2014-P-0856) asking for warnings to be placed on the Levaquin label regarding possible Mitochondrial Toxicity implicated in neurodegenerative diseases, including ALS, Alzheimer’s, and Parkinson’s. This Citizen Petition is based directly on an April 17, 2013 FDA report.
The FDA response to this petition, sent December 2014, states the FDA would not take action at this time because the Citizen Petition requires “extensive review and analysis by Agency officials.” Since this Citizen Petition is based on the FDA’s own words, from the FDA’s own research, outlined in the FDA’s own report, what the FDA is saying is that Agency officials have to review and analyze what the Agency officials themselves wrote.
Levaquin Psychiatric Citizen Petition
Dr. Bennett and The Southern Network on Adverse Reactions (SONAR) submitted a Citizen Petition to the FDA in September, 2014 (Docket #FDA-2014-P-1611) asking for additional warnings to be placed on the Levaquin label regarding about possible Psychiatric adverse events.
The FDA response to this petition, sent February 2015, states the FDA would not take action at this time because the Citizen Petition requires “extensive review and analysis by Agency officials.” This is the same response as the one provided by the FDA related to the Levaquin Mitochondrial Toxicity Citizen Petition.
FDA Responses to Both Citizen Petitions are Unacceptable
Given (1) the seriousness of the issues in the Levaquin Mitochondrial Toxicity Citizen Petition (neurodegenerative diseases, including ALS, Alzheimer’s and Parkinson’s); (2) that it is based on the FDA’s own report; and (3) that the FDA has made public statements that it is aware of the Levaquin Mitochondrial Citizen Petition, this Citizen Petition deserves a substantive response, not a generic reply.
Given the seriousness of the issues in the Levaquin Psychiatric Citizen Petition, this Citizen Petition deserves a substantive response, not a generic reply.
Respectfully,
Name:
Email :
Mr. Ostrof.f All of this talk about pain medication is over rated. I bet when Congressional Leaders have sever pain they receive the best America has to offer, while the rest of America has to suffer through the symptoms until they go away. Also, all of this food poisons that is going on with our food supply is a little strange. When we had independent farmers and dairy companies we never once heard about a case of food poison , if so it was very seldom, now that we have mega farm ran by government oversight we have a Constance occurrence of outbreaks. WHAT is going on with our food inspectors, and their ways of handling our food? Thanks.