FDA ISSUES BLACK BOX WARNING ON ALL FLUOROQUINOLONE ANTIBIOTICS
Fluoroquinolones are antibiotics that are commonly used to treat a variety of illnesses such as respiratory and urinary tract infections. These medicines include ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin). More than 23 million patients received a prescription for one of these drugs in 2011.
The FDA initially issued a warning in 2008 about the dangers associated with taking the fluoroquinolone class of antibiotics. A black box warning was placed on these antibiotics warning against severe tendon damage and rupture. In 2013, the FDA strengthened its warning- stating that fluoroquinolones, taken by mouth or injection carry a risk for permanent peripheral neuropathy. The safety announcement states:
“The U.S. Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy.
This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.
Peripheral neuropathy is nerve damage in the arms and/or legs, characterized by “pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or sense of body position.”
What Makes Fluoroquinolones So Dangerous?
Fluoroquinolones have fluoride as a central part of the drug. Fluoride is a known neurotoxin, and drugs with an attached fluoride molecule are able to penetrate into very sensitive tissues, including your brain.
The ability to cross the blood-brain barrier is what makes fluoride such a potent neurotoxin. Fluoride also disrupts collagen synthesis, and can damage your immune system by depleting energy reserves and inhibiting antibody formation in your blood.
According to Todd R. Plumb, M.D.–a physician and fluoroquinolone victim—fluoroquinolone toxicity appears to be functional. Based on the available research, he cites the following four possible mechanisms of harm by fluoroquinolones:
A) Inhibition or disruption of the central nervous system GABA receptors
B) Depletion of magnesium and disruption of cellular enzyme function
C) Disruption of mitochondrial function and energy production
D) Oxidative injury and cellular death
Cipro, Levoquin, Avelox May Be The Deadliest Antibiotics On The Market
Besides nerve damage, they have been associated with damage to other body systems, including your musculoskeletal system, eyes and kidneys. What makes these particular drugs so hazardous?
It has to do with the fact that fluoroquinolones are antibiotics whose potency has been “kicked up” by the addition of a fluoride molecule. Fluoride increases permeability into hard-to-penetrate tissues, such as your brain.
In terms of peripheral neuropathy, the FDA was not exactly quick to take action. Adverse reactions of fluoroquinolones were documented in Europe as far back as the 1980s:
In 2001, Dr. Jay Cohen documented the following fluoroquinolone-related reactions, yet it took more than a decade—and many destroyed lives—for the FDA to take action.
Dr. Cohen revealed the following reactions:
Nervous system symptoms occurred in 91 percent of patients taking fluoroquinolones (pain, tingling and numbness, dizziness, malaise, weakness, headaches, anxiety and panic, loss of memory, psychosis)
Musculoskeletal symptoms in 73 percent of patients (tendon ruptures, tendonitis, weakness, joint swelling)
Sensory symptoms in 42 percent of patients (tinnitus, altered visual, olfactory, and auditory function)
Cardiovascular symptoms in 36 percent of patients (tachycardia, shortness of breath, chest pain, palpitations)
Skin reactions in 29 percent of patients (rashes, hair loss, sweating, intolerance to heat or cold)
Gastrointestinal symptoms in 18 percent of patients (nausea, vomiting, diarrhea, abdominal pain)
In a letter to his Congressman, Dr. Cohen wrote:
“These severe reactions are occurring in patients who are usually healthy, active, and young. Most often, the antibiotics are prescribed for mild infections such as sinusitis, urinary or prostate infections. Most reactions occur very quickly, sometimes with just a few doses of the fluoroquinolone antibiotic.
Reactions are acute, severe, frightening, and often disabling.”
Despite persistent warning signs, the FDA didn’t take action until 2008, at which point they added a black box warning about severe tendon damage. They waited another five years before issuing a warning about permanent neuropathy.
This is yet another sad example demonstrating that just because a drug is FDA approved does NOT mean it has a proven safety record.
Fluoroquinolones have also been associated with the following health problems and adverse effects:
1. Peripheral Neuropathy
2. Disruption to blood sugar metabolism
3. Retinal detachment
4. Acute kidney failure
5. Brain fog
7. Hearing problems
8. Painful rashes
Levaquin, the best-selling antibiotic in 2010, actually faces thousands of lawsuits per year from people who have been seriously harmed by taking it.
Headed For More FDA Warnings?
Two other recent studies may foreshadow even more warnings about fluoroquinolones, in terms of liver toxicity and greater risks for people with diabetes.
Moxifloxacin (Avelox) and levofloxacin (Levaquin) were found to increase the risk for acute liver toxicity in people age 66 and up. The findings were published in the Canadian Medical Association Journal in August 2012. The authors recommended FDA consider regulatory warnings regarding acute liver toxicity.
Oral fluoroquinolones cause an increased risk of dysglycemia (high blood sugar or low blood sugar reactions) for those with diabetes, according to a study in the August 14, 2013 issue of Clinical Infectious Diseases. Fluoroquinolones are thought to be particularly dangerous for children under age 18, adults over 60, and pregnant and nursing women, as well as for people with liver disease, diabetes, or those taking corticosteroids or nonsteroidal anti-inflammatory drugs (NSAIDs). But, they are often prescribed for these groups anyway, without even a passing thought.
Sourced through Scoop.it from: articles.mercola.com
CIPRO, LEVOQUIN and AVELOX MAY BE THE DEADLIEST ANTIBIOTICS ON THE MARKET.
Comments by Dr. Monteiro:
This group of antibiotics, fluoroquinolones, are so damaging that the FDA has issued 2 Black Box Warnings on these drugs. The first in 2008, warned of severe tendon damage and rupture; the second, in 2013, warned of permanent peripheral nerve damage and the possibility is high that another warning may be issued soon on liver damage and glucose dysregulation. These antibiotics have also been linked to aortic dissections and aortic aneurysm. The aorta is the largest blood vessel in the body and these antibiotics can damage the lining or cause tears. Both of these conditions are deadly and few if any survive them, yet, we still find these dangerous antibiotics on the market.
Fluoroquinolone antibiotics are prescribed for infections such as, urinary tract infections, prostate infections, respiratory infections, sinus infections, pelvic inflammatory disease, gastroenteritis and joint and bone infections. These antibiotics are even prescribed to our poor unsuspecting pets. It seems that veterinary doctors as as clueless as the vast majority of human doctors when it comes to the risks of these antibiotics. The difference is…WE HAVE A CHOICE. OUR ANIMALS DO NOT.
Cipro is the most widely prescribed of all the fluoroquinolones, making up 80% of all prescriptions. Levaquin is the 2nd most popular drug in this class, with 28% of all prescriptions and in 2010 was actually the ‘best selling’ (ie: best money making) antibiotic in the U.S. The reality is that these drugs, the most widely prescribed, were never meant to be used as a first line of defense. They were intended to be used in critical cases, where all else had failed.
Dr. Mahyar Etminan, an epidemiologist at the University of British Columbia, told The New York Times that overusing these drugs is like “Trying to kill a fly with an automatic weapon.”
Just recently, May 12, 2016, the FDA announced that it is requiring an even stronger black box warning. FDA states:
“Risks May Outweigh Benefits For Levaquin, Cipro”
I urge you, next time your doctor hands you a prescription for Cipro, Levaquin or Avelox, decline it vehemently. Your life and your health depend upon it.
This blog has been provided by Dr. John Coppola, D.C. and Dr. Valerie Monteiro, D.C. Dr. Coppola and Dr. Monteiro are the founders of the San Antonio Neuropathy Center, and Precision Sport & Spine. They are the leading experts in the field of neuropathy and specifically drug free nerve repair. They are the authors of the critically acclaimed book “Defeat Neuropathy Now …. In Spite of Your Doctor. The doctors have over 25 years of clinical experience.
If you would like to reach the doctors regarding a specific health problem, you may email them at [email protected].