Citizens Petition- Mitochondrial Toxicity

QVF supports the initiative bring about a third black box warning for Mitochondrial Toxicity, causing such diseases as Lou Gehrig's Disease, Parkinsons Diesease, and Alzheimer's. In its entirety:

"On June 18, 2014, Dr. Charles Bennett, University of South Carolina, submitted a Citizen Petition to Dr. Margaret Hamburg, FDA Commissioner, asking for the following Black Box Warning:


WARNING: POSSIBLE MITOCHONDRIAL TOXICITY

Fluoroquinolones may cause Mitochondrial Toxicity. Mitochondrial Toxicity has been implicated in conditions such as peripheral neuropathy, hepatoxicity, glucose disturbances, phototoxicity, developmental disorders of the brain, optic neuropathy, neuropathic pain, hearing loss, muscle weakness, cardiomyopathy, lactic acidosis, Parkinson’s, Alzheimer’s, and amyotrophic lateral sclerosis (ALS).

FDA Urged To Add New Black Box Warning On J&J's Levaquin

By Jeff Overley

New York (July 18, 2014, 5:17 PM ET) -- The U.S. Food and Drug Administration should slap an additional black box warning on Johnson & Johnson’s antibiotic Levaquin because of potential cellular damage that could cause an array of serious diseases, a university group said in a citizen petition released Friday.

In its petition, the Southern Network on Adverse Reactions — a project of the South Carolina College of Pharmacy at the University of South Carolina — urged the FDA to update Levaquin’s warning labels to reflect the possible risk of damage to mitochondria that reside in cells and help convert food into usable energy.

Under SONAR’s request, a warning would say that Levaquin, or levofloxacin, might cause mitochondrial toxicity that has been linked to Alzheimer’s disease, Parkinson’s disease, Lou Gehrig’s disease and liver damage. It would also mention a connection between mitochondrial toxicity and various nerve disorders, or neuropathies, that have long been associated with levofloxacin and other antibiotics in the class of so-called fluoroquinolones.

As a basis for the action, the petition pointed to FDA research that has suggested some of the risks presented by fluoroquinolones stem from damage to mitochondria. The petition then cited the FDA’s database of adverse events to argue that reports of side effects have occurred more commonly with Levaquin than with other fluoroquinolones, such as Bayer AG’s Cipro.

Because Levaquin is “sometimes the clinically most appropriate drug of choice,” not all of those adverse events would be averted by a new black box warning, SONAR wrote. But if there had been warnings about mitochondrial toxicity, then “physicians may not have prescribed Levaquin for some patients,” the petition said.

“Given that many of these individuals were most likely enrolled in Medicare and Medicaid, this could significantly reduce the overall cost of these government-funded programs,” SONAR added.

Levaquin and other fluoroquinolones were the subject of another citizen petition filed by advocacy group Public Citizen in 2006 that sought a black box warning alerting patients and doctors to the risk of tendon rupture when using the drugs. Public Citizen later brought suit to force the change, and the FDA added that warning in 2008.

Extensive product liability litigation has played out over alleged harm from Levaquin, but J&J has had some success beating back complaints. The drugmaker didn’t immediately respond Friday to requests for comment.



Quinolone Vigilance Foundation wishes to thank Dr. Bennett and SONAR for their hard work and dedication.

*PLEASE NOTE*- Only one drug could be chosen and Levaquin was picked. This is NOT just for Levaquin. When one black box warning is added, they are added to all FQs.
Rachel Brummert, Executive Director/President of Quinolone Vigilance Foundation."