FDA Fails to Go The Distance, Yet Again

As reported by Channel 2 Consumer Investigator Jim Strickland on August 1, 2016, federal regulators have no plans to formally notify individual doctors about the new warning label on the powerful class of antibiotics, the Fluoroquinolones (FQs).

In what this author considers yet another failure of the FDA to completely go the distance after strengthening warnings for the FQ’s, it boggles the mind that the FDA would not send out formal notifications to physicians, since this encompasses a public safety issue that could have catastrophic consequences if not heeded.

According to Strickland, “Rather than notifying the medical community in writing, the FDA is relying on press releases and online newsletters to get the word out.”

The FDA may consider using press releases and online newsletters as formal notification, but this author does not.

After a tremendous effort by Dr. Bennett, a handful of dedicated floxies who met with the FDA on numerous occasions, dozens of heroic floxies who testified at the Nov. 5th 2015 hearing, and hundreds more who shared their stories of suffering, a label change was issued by the FDA. Now the FDA needs to follow completely through with formal notifications.

The FDA has a legal responsibility to act appropriately in the best interest of public safety.

Dr. Charles Bennett, pharmaceutical safety professional and strong advocate for fluoroquinolone safety said that most doctors are too busy to take notice and notifying via press releases and online newsletters does not make sense.

As I previously wrote in the article “FDA Shell Game? I Hope Not”, the FDA failed to go the distance when, even though they agreed to a label change, they dismissed the citizen petition on mitochondrial toxicity brought about by Dr. Charles Bennett and his SONAR group.  By dismissing the citizen petition on mitochondrial toxicity they hampered an avenue that could lead to testing and further research to help those already harmed by the fluoroquinolones.

This dismissal occurred despite the fact there has been research as far back as 1996 that showed mitochondrial toxicity (1) and their own 2013 interFDA Falling Shortnal memo hinted at mitochondrial toxicity as the source of peripheral neuropathy.

Failing to go the distance seems to be a distinct pattern within the FDA.

It is the opinion of this author that some medical professionals could hide behind the cloak of plausible deniability when it comes to the new label changes, due to the fact that no formal notifications are being made.  Again, this shirks the FDA’s role to fully act appropriately in the best interest of public safety.

Don’t get me wrong. I am ecstatic about the new label changes. But given the FDA’s past track record,  I will not happy until every medical professional, who has the ability to prescribe a FQ, is familiar with the label changes and safety precautions.

“Who benefits from the FDA not formally notifying medical professionals?”

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

Admin

...damaged by fluoroquinolones in 2007 at age 46. Prior to, a healthy law enforcement official. Now an amateur FQ researcher, author, and blogger.

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