FDA Requires Warnings for Fluoroquinolone Drugs (Cipro, Levaquin, Avelox, Floxin)

FDA Requires Warnings for Fluoroquinolone Drugs (Cipro, Levaquin, Avelox, Floxin)

August 18th, 2013 by Loretta Lanphier, NP, CN, CH, HHP

FDA Requires Warnings for Fluoroquinolone Drugs (Cipro, Levaquin, Avelox, Floxin)

On August 15, 2013, the FDA put out yet another Safety Announcement concerning fluoroquinolone drugs such as Levaquin, Cipro and Avelox which states that these drugs will now be required to contain a warning for severe, permanent and disabling peripheral neuropathy. The FDA Safety Announcement also indicates that damage can occur in the very beginning of treatment with fluoroquinolone drugs and the damage can be permanent or last for years after treatment is stopped. (See 2016 updated warnings below under Official Safety Announcement from the FDA)

What is peripheral neuropathy?  The FDA describes Peripheral neuropathy as follows: Peripheral neuropathy is a nerve disorder occurring in the arms or legs. Symptoms include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position.

Livatrex

Adverse Effect History of Fluoroquinolone Drugs

The quinolones are a family of synthetic broad-spectrum antibacterial drugs. The first generation of quinolones began with the introduction of nalidixic acid in 1962 for treatment of urinary tract infections in humans. Nalidixic acid was discovered by George Lesher and coworkers in a distillate during an attempt at chloroquine synthesis. Quinolones exert their antibacterial effect by preventing bacterial DNA from unwinding and duplicating. The majority of quinolones in clinical use belong to the subset fluoroquinolones, which have a fluorine atom attached to the central ring system, typically at the 6-position or C-7 position.

Ciprofloxacin (CIPRO) is the most widely used of the second-generation quinolone antibiotics that came into clinical use in the late 1980s and early 1990s. In 2010, over 20 million outpatient prescriptions were written for ciprofloxacin, making it the 35th-most commonly prescribed drug, and the 5th-most commonly prescribed antibacterial, in the US. Ciprofloxacin was first patented in 1983 by Bayer A.G. and subsequently approved by the US Food and Drug Administration (FDA) in 1987. Ciprofloxacin has 12 FDA-approved human uses and other veterinary uses, but it is often used for unapproved uses (off-label).

In July of 2008 the FDA issued the following Safety Announcement about fluoroquinolone drugs: FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients.

In 2010, Levaquin was the best-selling antibiotic in the United States. But by 2011 it was also the subject of more than 2,000 lawsuits from patients who had suffered severe reactions after taking it.

bg-quote2As many as one-third of patients taking a fluoroquinolone will experience some sort of negative psychiatric effect, such as anxiety, personality changes, or confusion. The psychiatric effects of the fluoroquinolones are under appreciated by the medical profession as well as by the public. The bigger the gun you use, the more damage you can expect as collateral.  David A. Flockhart, professor of medicine and chief of clinical pharmacology at Indiana University School of Medicine.

In a 2001 study by Dr. Jay Cohen, the following reaction rates were documented:(1)

  • Nervous system symptoms occurred in 91 percent of patients (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 the following:

bg-quote2

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. Since the publication of my article with its 45 cases two and a half years ago, I have received e-mails from more than 100 people seeking help for their reactions. In most cases, their doctors have dismissed their complaints or outright denied that the reactions could occur with fluoroquinolones. Yet extensive medical workups do not find any other cause. Worse, there are no known effective treatments. Thus, these people suffer pain and disability for weeks, months, and years.

Another concern is that fluoroquinolones are usually inappropriately prescribed. Instead of being reserved for use against serious, perhaps life-threatening bacterial infections like hospital-acquired pneumonia, these antibiotics have been frequently prescribed for sinusitis, bronchitis, earaches and other illnesses that could resolve on their own or could be treated with less potent drugs or non-drug remedies — or are caused by viruses, which are not susceptible to antibiotics.(2)

See the THE MECHANISMS OF FLUROQUINILONE-ASSOCIATED DISABILITY (Cipro,floxacin, Levaquin, Avelox) PDF CHART for more info. Also check out the “Dear Colleague” letter by Dr. Miriam J. de Jong which provides many, many resource for the chart. It can be read HERE.

Optimum Wellness Starter Oxygen Colon CleanseSome Side Effects Reported by Users
of Fluoroquinolone Drugs

  • tendon rupture
  • peripheral neuropathy
  • retinal detachment
  • fibromyalgia symptoms
  • liver injury
  • kidney injury
  • dry eyes, mouth and skin
  • ringing in ears
  • delayed urination
  • uncontrollable shaking
  • burning pain in eyes and feet
  • tingling in hands and feet
  • heart palpitations
  • muscle spasms
  • central nervous system injury (causing “brain fog,” depression, hallucinations and psychotic reactions)
  • Hematologic abnormalities such as anemia, methemoglobinemia, leukopenia, granulo-cytopenia, increased or decreased prothrombin time, and increased or decreased platelet counts
  • skin (painful, disfiguring rashes and phototoxicity)
  • gastrointestinal system (nausea and diarrhea)
  • antibiotic-resistant Staphylococcus aureus (known as MRSA) and severe diarrhea caused by Clostridium difficile. One study found that fluoroquinolones were responsible for 55 percent of C. difficile infections at one hospital in Quebec.

Official Safety Announcement from the FDA

UPDATE: AS OF MAY 12, 2016: FDA Issues New Stronger Warnings About Risks Of Fluoroquinolone Antibiotics, saying “An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, andinjectable) are associated with disabling and potentially permanent serious side effects that can occur together.These side effects can involve the tendons, muscles, joints, nerves and central nervous system.

FDA Warning Label – Ciprofloxacin (Cipro) 
2016 update to the Ciprofloxacin (Cipro) warning label

FDA Warning Label – Levofloxacin (Levaquin) 
2016 update to the Levofloxacin (Levaquin) warning label

FDA Warning Label – Moxifloxacin (Avelox) 
2016 update to the Moxifloxacin (Avelox) warning label

[8-15-2013]  (http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm) 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 (see Table for a list) may occur soon after these drugs are taken and may be permanent.

The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection.  Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive).  The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.

If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk. Peripheral neuropathy is a nerve disorder occurring in the arms or legs. Symptoms include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position.  It can occur at any time during treatment with fluoroquinolones and can last for months to years after the drug is stopped or be permanent.  Patients using fluoroquinolones who develop any symptoms of peripheral neuropathy should tell their health care professionals right away.

FDA will continue to evaluate the safety of drugs in the fluoroquinolone class and will communicate with the public again if additional information becomes available.

Facts about the fluoroquinolone drug class

  • Antibacterial drugs approved for the treatment or prevention of certain bacterial infections.
  • Approximately 23.1 million unique patients received a dispensed prescription for an oral fluoroquinolone product from outpatient retail pharmacies during 2011.  Patients receiving a dispensed prescription for ciprofloxacin, levofloxacin, or moxifloxacin accounted for 70%, 28%, and 9% of the total number of patients, respectively, during 2011.  Gemifloxacin, ofloxacin, and norfloxacin each accounted for less than 1% of total patients during 2011.
  • Within the hospital setting, there were approximately 3.8 million unique patients billed for an injectable fluoroquinolone product during 2011.  Levofloxacin, ciprofloxacin, and moxifloxacin accounted for 63%, 28%, and 13% of total unique patients, respectively, during 2011; hospital billing for ofloxacin was not captured.


List of approved Fluoroquinolone Drug products

Generic name Contained in Brand name
levofloxacin Levaquin
ciprofloxacin Cipro
moxifloxacin Avelox
norfloxacin Noroxin
ofloxacin Floxin
gemifloxacin Factive

If you or a loved one have been harmed from the use of fluoroquinolone drugs contact the FDA at:

1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem
MedWatch Online
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857


References & Research

Ann PharmacotherDecember 1, 2001 vol. 35 no. 12 1540-1547 

New York Times: Popular Antibiotics May Carry Serious Side Effects

Rubinstein E. History of quinolones and their side effects. Chemotherapy. 2001;47(S2):3-8.

Carbon C. Comparison of side effects of levofloxacin versus other fluoroquinolones. Chemotherapy.2001;47(S2):9-14.

Shehab N, Patel PR, Srinivasan A, Budnitz DS. Emergency department visits for antibiotic-associated adverse events. Clin Infect Dis. Centers for Disease Control and Prevention. 2008;47(6):735-743.

LaSalvia EA, Domek GJ, Gitlin DF, et al. Fluoroquinolone-induced suicidal ideation. Gen Hosp Psychiatry. 2010;32:108-10.

Labay-Kamara U, Manning S, McMahon T. Fluoroquinolone-induced suicidal ideation and suicidality. Psychosomatics. 2012 Jan-Feb;53:1.

Qian Qi, Nasr SH, Akogyeram CO, et al. Myoglobin-associated acute kidney injury in the setting of ciprofloxacin administration. Am J Kidney Dis. 2012;59(3):462-66.

Figueira-Coelho J, Pereira O, Picado B, et al. Acute hepatitis associated with the use of levofloxacin. Clin Ther. 2010 Sep;32(10):1733-7.

Werner NL, Hecker MT, Sethi AK, et al. Unnecessary use of fluoroquinolone antibiotics in hospitalized patients. BMC Infectious Diseases. 2011;11:187.

Karabay O, Ozdemir D, Guclu E, et al. Attitudes and behaviors of family physicians regarding use of antibiotics. JMID. 2011;1(2):53-57.

White AR (BSAC Working Party on the Urgent Need: Regenerating Antibacterial Drug Discovery and Development). Effective antibacterials: at what cost? The economics of antibacterial resistance and its control. 2011;66:1948-53.

The spread of superbugs: What can be done about the rising risk of antibiotic resistance? The Economist. Mar 2011.

Mehnert-Kay SA. Diagnosis and management of uncomplicated urinary tract infections. Am Fam Physician. 2005;72:451-6.

U.S. Food and Drug Administration. Information for Healthcare Professionals: Fluoroquinolone Antimicrobial Drugs [ciprofloxacin (marketed as Cipro and generic ciprofloxacin), ciprofloxacin extended-release (marketed as Cipro XR and Proquin XR), gemifloxacin (marketed as Factive), levofloxacin (marketed as Levaquin), moxifloxacin (marketed as Avelox), norfloxacin (marketed as Noroxin), and ofloxacin (marketed as Floxin)]. May 2009. Retrieved at: http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm126085.htm.

U.S. Food and Drug Administration. Risk of fluoroquinolone-associated Myasthenia Gravis Exacerbation February 2011 label changes for fluoroquinolones. March 2011. Retrieved at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm247115.htm.

Fisk, MC, Hawkins, B. Johnson & Johnson settles 845 Levaquin lawsuits. Bloomberg Businessweek. Nov 2011. Retrieved from: http://www.businessweek.com/news/2012-11-01/johnson-and-johnson-reaches-settlement-in-845-levaquin-cases

Powers JH. Risk perception and inappropriate antimicrobial use: Yes, it can hurt. Clin Infect Dis. 2009;48:1350-3.

Flynn R, Eckel E, Zuckerman D. National Research Center for Women and Families. The facts about medication for colds and the flu. May 2011. Retrieved at: http://www.center4research.org/2010/03/the-facts-about-medication-for-colds-and-the-flu/.

American College of Physicians. Antibiotics: Do you really need them? Retrieved at: http://www.acponline.org/patients_families/pdfs/health/antibiotics.pdf.

Loretta Lanphier is a Naturopathic Practitioner (Traditional), Certified Clinical Nutritionist, Holistic Health Practitioner and Certified Clinical Herbalist as well as the CEO / Founder of Oasis Advanced Wellness in The Woodlands TX. She has studied and performed extensive research in health science, natural hormone balancing, anti-aging techniques, nutrition, natural medicine, weight loss, herbal remedies, non-toxic cancer support and is actively involved in researching new natural health protocols and products.  A 14 year stage 3 colon cancer survivor, Loretta is able to relate to both-sides-of-the-health-coin as patient and practitioner when it comes to health and wellness. “My passion is counseling others about what it takes to keep the whole body healthy using natural and non-toxic methods.” Read Loretta’s health testimony Cancer: The Path to Healing. Loretta is Contributor and Editor of the worldwide E-newsletter Advanced Health & Wellness
†Results may vary. Information and statements made are for education purposes and are not intended to replace the advice of your doctor. Oasis Advanced Wellness/OAWHealth does not dispense medical advice, prescribe, or diagnose illness. The views and nutritional advice expressed by Oasis Advanced Wellness/OAWHealth are not intended to be a substitute for conventional medical service. If you have a severe medical condition or health concern, see your physician of choice.

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  • ciprovictimalso

    Do you really think the FDA cares?

    • Janet Werner Abele

      I do hope so, it is a Federal office for the safety of our Citizens..

  • Janet Werner Abele

    my daughter, who has severe special needs and chronic ear infections is constantly on antibiotics, recently, just two weeks ago, was on Cipro, and needed to stop it, due to stomach upset, vomiting, loose stools and now does has a tear on top of her backside, which I have been using Nystatin cream on it and special soap which is a liquid soap , for wounds. I intend to call Dr. about the sore tomorrow.

  • UCSD Fluoroquinolone Effects Study

    Have you taken an antibiotic such as Cipro (ciprofloxacin), Levaquin (levofloxacin), or Avelox (moxifloxacin)? Would you be willing to help in a survey-based medical research study?

    Dr. Beatrice A. Golomb and her colleagues at the University of California, San Diego are conducting a new study to identify and describe side effects and risk factors for good and bad outcomes involving antibiotics in the fluoroquinolone class. Other example fluoroquinolones include Zymar (gatifloxacin), Floxin (ofloxacin), Zagam (sparfloxacin), Trovan (trovafloxacin), Tavanic, and Vigamox.

    Whether you believe you have experienced side effects or you believe you have tolerated them, you are invited to participate in this voluntary study. Participants possessing English language fluency from all countries are accepted.

    Study participants will be asked to complete questionnaire(s). By participating in these surveys, you can help us further understand the effects of fluoroquinolones and report findings to the medical community (including prescribing physicians) and the general public. Surveys will cover your overall health, well-being, fluoroquinolones taken, and symptoms; impacts on your life and career; and your personal story.

    For those without side effects, there is currently just one survey taking 20-30 minutes to complete.

    For those having adverse effects, there are currently 3 (voluntary) questionnaires that can be done separately, each taking approximately 40-90 minutes (time varies per individual). Each survey addresses a different set of concerns related to fluoroquinolone effects. More voluntary surveys may be available in the future. Compensation for taking the surveys is not available.

    If there is a chance you are interested in participating, please visit our website at:

    http://www.fqstudy.info

    for further information on this important study.

    If you know of anyone else who might consider participating, then please pass on our website address. We truly appreciate your participation and referrals.

    -The UCSD Fluoroquinolone Effects Study

  • Pingback: Why You Should Avoid These Commonly Prescribed Antibiotics at All Costs | Natural Health Online()

  • since taking cipro i am constantly in pain.i cannot exercise without hurting something.knees,wrists,neck,dry yes.all hurt after even doing lite strecthing.dr thinks im nuts
    sad that doctors are so ignorant today

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