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 :