Recently I described how a group of us, individuals from the Fluoroquinolone (FQ) community, met with FDA Officials to discuss FQ’s and to press for mitochondrial warnings, consistent with the June 2014 Citizen Petition, to be added to FQ labels. You can read that article here. In this article I highlight a very important aspect of that meeting.
Why is our group so adamant to get mitochondrial toxicity wording on the FQ packaging? Mitochondrial toxicity is mitochondrial damage and it has the potential to be long-lasting, permanent, and cross-generational. Because of this, it could pose a tremendous risk to our children.
One of the most sobering aspects of this warning is highlighted in the August 14, 2014 FDA’s Pediatric Postmarketing Pharmacovigilance and Drug Utilization Review (PPPDUR). According to the PPPDUR almost 100,000 pediatric Levaquin prescriptions were written between April 2011 and March 2014. Even though we, as a community, are used to hearing about large numbers of FQ prescriptions in adults, think about it; almost 100,000 prescriptions for Levaquin for children in just 3 years!
All, of the almost 100,000 pediatric Levaquin prescriptions, were written for off-label usage! Although the FDA fails to comment on the off label usage, the only approved usage for Levaquin in the pediatric population is for the Plague or Anthrax.
Sadly, the FDA review states that children experience the same Levaquin Adverse Events as adults. This means that the children have the possibility of experiencing adverse events that are consistent with mitochondrial toxicity.
No one knows for sure, at this time, how much genetic damage is being passed on to children from their parents, due to parental usage and parental mitochondrial toxicity from the FQ’s. However, these sobering statistics show that even besides parental usage, direct FQ pediatric usage is putting our most precious asset, which is the next generation, at risk for long term very serious health issues; health issues that are probably preventable.
We must all do what we can to stop this travesty that is why it is so vitally important to unite and do what you can; stand behind the Citizen Petition Process, promote media stories, encourage everyone to share their story on www.fluoroquinolonestories.com, stay vigilant, stay informed, and stay tuned to My Quin Story for timely updates on our interactions with the FDA, the Citizen Petitions, pediatric FQ usage, and community related research.