It is important that we keep continual pressure on the Food and Drug Administration (FDA) about the various dangers that the Fluoroquinolones (FQ) pose to the public.

Previously the FQ community has met with the FDA on June 10th, 2015 and again on April 23rd, 2015 to address mitochondrial warnings and to pressure the FDA to act.

On August 24th, 2015, Dr. Charles Bennett, Terry Aston, John Fratti, Dr. Linda Martin, David Melvin, and Dr. Alan Redd met with staff from the FDA in a third meeting to address the various FDA failures to adequately warn the general public about the true dangers FQ’s pose to the general public, especially our children.

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Terry Aston & Dr. Bennett at the FDA

There were two agenda items: (1) Pediatric Levaquin; and (2) Fluoroquinolone Rhabdomyolysis.

Pediatric Levaquin Discussion

The group reviewed data from the August 14, 2014 FDA Pediatric Postmarketing Pharmacovigilance and Drug Utilization Review which discusses Pediatric Levaquin use. This review explains that nearly 100,000 prescriptions were written for Pediatric Levaquin from April 2011 – March 2014. The group pointed out that 100% of these prescriptions were for diagnoses not approved by the FDA.

There was also discussion of the August 14, 2014 FDA Pediatric Postmarketing Pharmacovigilance and Drug Utilization Review sections which indicate that Pediatric Levaquin adverse events are the same as adults with the implication that this makes Pediatric Levaquin use acceptable. The group explained that adult FQ adverse events are unacceptable for adults, so they should also be considered unacceptable for children.   I wrote a previous article about The Sad Truth of Pediatric Fluoroquinolone Usage.

Dr. Bennett and Group Recommendations to the FDA Regarding Pediatric Levaquin

It is recommended that:

  1. The FDA distribute an FDA Drug Safety Communication that clearly states that physicians should only prescribe FQs for the treatment of inhalational anthrax (post-exposure) and plague because the risk-benefit is only appropriate for these uses.
  2. The FDA closely monitor FQ Pediatric use to ensure that physicians are only prescribing FQs for FDA-approved uses.
  3. The FDA implement a restricted distribution for Pediatric FQ use.

Rhabdomyolysis Discussion

The group reviewed the Rhabdomyolysis FDA Adverse Event Reporting System (FAERS) data. More than 400 cases of Rhabdomyolysis following FQ consumption have been reported to the FDA. Because this represents only 10% to 1% of the actual number of cases, the estimated number of Rhabdomyolysis cases is 4,000 to 40,000.

The following was also noted:

  • FDA acknowledges Rhabdomyolysis as an FQ AE in the Levaquin label under the “Post-Marketing Reports of Adverse Events” section.
  • Rhabdomyolysis is not on the FQ labels under the “Warnings and Precautions” or “Adverse Events” sections.
  • Other FQ AEs with fewer FAERS reports than Rhabdomyolysis are on the FQ labels under the “Warnings and Precautions” or “Adverse Events” sections.

Dr. Bennett and Group Recommendations to the FDA Regarding Rhabdomyolysis
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It is recommended that:

  1. The FDA add the following to the FQ labels under the “Warnings and Precautions” and “Adverse Events” sections: Serious and occasionally fatal Rhabdomyolysis has been reported in patients receiving therapy with fluoroquinolones.

We continue to make our concerns about the various dangers that FQ’s pose for the general public a topic that is not forgotten or dismissed by the FDA.

Stayed tuned to My Quin story for timely updates on our interactions with the FDA, Dr. Bennett and the Citizen Petition, and community related research.

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