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:
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
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
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
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.
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.
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.
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.
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.
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."