Quinolone Vigilance Foundation Warns Levaquin, Cipro, Avelox May Result In Neurodegenerative Diseases
FDA and Drug Makers Fail to Warn Doctors and Patients
N.J., Sept. 2, 2014 /PRNewswire-iReach/ -- Four years ago, Lisa was a
physically active and healthy 45 year old. She would frequently unwind
at the local gym after spending a long day on her feet teaching a class
of energetic elementary school students. All of that changed
dramatically when she took an antibiotic for a sinus infection. Lisa's
doctor prescribed the popular antibiotic, Levaquin, a drug she was told
was safe. She became so disabled, she was unable to continue working.
Lisa's doctor was at a loss to explain the sudden onset of these
painful, debilitating symptoms, particularly when they continued to
worsen months after she had stopped taking the antibiotic.
belongs to a class of antibiotics called Fluoroquinolones. Originally
manufactured to treat serious, life-threatening infections, they have
been increasingly used for minor infections and, in some cases, when no
infection exists. A common misconception is that they are safe,
despite several Black Box warnings, which include Central Nervous
System (CNS) dysfunction and increased risk of tendon rupture. In August
2013, the FDA strengthened Levaquin's warning to include the risk of
Peripheral Neuropathy, which can be permanent.
doctors have struggled to explain Fluoroquinolone Toxicity Syndrome,
part of the explanation may be found in an April 17, 2013 FDA report
which indicates Levaquin, Cipro, and Avelox may cause Mitochondrial
Toxicity. This report, obtained through a Freedom of Information
request, states that Mitochondrial Toxicity is implicated in serious,
life-threatening neurodegenerative conditions, such as Parkinson's,
Alzheimer's, and ALS.
Based on this 2013 FDA report, signed by an
FDA Acting Division Director, Dr. Charles Bennett from the University
of South Carolina, submitted a Citizen Petition to the FDA requesting a
Black Box warning be added to the Levaquin label which would warn
doctors and patients of the risk for Mitochondrial Toxicity.
Quinolone Vigilance Foundation (QVF), www.SaferPills.org,
a non-profit, charitable organization that fosters, initiates, and
funds research on Fluoroquinolone Toxicity, supports the Citizen
Petition. Rachel Brummert, QVF Executive Director, herself injured by
Levaquin in 2006, was diagnosed four years later with Neurosarcoidosis,
a degenerative neurological disorder that is linked to Mitochondrial
Toxicity. "The failure by the FDA and drug makers to adequately warn
the public puts patients at an alarmingly high risk of developing
life-threatening neurodegenerative disorders," said Brummert. "We call
on the FDA and drug makers to protect the American public and issue
this important warning immediately."
John Fratti, also
damaged by Levaquin and is a staunch advocate for additional Black Box
warnings, agrees with Brummert. "Doctors and patients should not have
to obtain drug safety information through a Freedom of Information Act
request. The boxed warning requested by the Citizen Petition is needed
For Lisa, who still struggles with the
aftermath of the damage caused by Levaquin, the requested Citizen
Petition Black Box warning will come too late. It may, however, prevent
others from suffering a similar fate.
Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, 609-575-9839, email@example.com
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SOURCE Quinolone Vigilance Foundation
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