US and Europe update Antibiotic Warnings

Fluoroquinolone antibiotics, often found in your medicine cabinet or travel kit, have the potential of permanent disabling side effects with no known treatment. Imagine you take this antibiotic for a common UTI or sinus infection and a month later your knee or elbow becomes unstable or you suddenly have plantar fasciitis. These may seem unrelated but the serious side effects are well documented in medical literature.  The drug label warns “any tendon at any age” may be affected.   

As a patient, you have to be your own advocate for your and your family’s health and request your medical providers to research safer alternatives.  Be aware that these antibiotics can cause unexplainable tendon damage and nervous system damage the first time you are exposed or not until you have had many exposures.

Both the FDA and the European Medicines Agency have recommended that this powerful class of antibiotics be used as a last resort medication only, when no other options are available for patient care, due to serious disabling side effects. The FDA and EMA have strongly advised that this class of antibiotics NOT be used for common UTI’s, COPD, and Sinus Infections.

The FDA continues to actively review submitted case studies and published medical literature since an important hearing was convened in 2015 that brought to their attention the disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. This has been referred to as Fluoroquinolone Associated Disability (FQAD).

Below find links to the safety label changes that have been required in recent years.

These links will identify fluoroquinolones and show the history of the FDA warnings. 

List of fluoroquinolone drugs with generic names.  There are so many names for these drugs. https://www.drugs.com/drug-class/quinolones.html

December 2018  The FDA warned about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients https://www.fda.gov/Drugs/DrugSafety/ucm628753.htm

July 2018  The FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics and required label changes https://www.fda.gov/drugs/drug-safety-and-availability/fda-reinforces%5B1%5Dsafety-information-about-serious-low-blood-sugar-levels-and-mental-health-side

July 2016 The FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects (disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. https://www.fda.gov/Drugs/DrugSafety/ucm511530.htm

May 2016  The FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together (Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations.) https://www.fda.gov/Drugs/DrugSafety/ucm500143.htm   

August 2013  The FDA required label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection (Peripheral Neuropathy)

October 2008  Warning on Tendon Injuries with Fluoroquinolone Antibiotics – FDA Patient Safety News

List of common Fluoroquinolone Antibiotics

It is important to have a list of the most common drugs in this category of Fluoroquinilone antibiotics.  If your doctor prescribes one of these drugs… START ASKING QUESTIONS!  Tell your doctor to refer to the FDA updated warnings as of July 26, 2016.

Oral Antibiotics that are commonly prescribed.

  • Avelox (moxifloxacin)
  • Cipro (ciprofloxacin)
  • Factive (gemifloxacin)
  • Levaquin (levafloxacin)
  • Noroxin (norfloxacin)

Eye Drops There are fluoroquinolones in eye drops! You might have an infection or they might be prescribed after eye surgery.  There are other antibiotics that are safer.

  • Besivance (besifloxacin)
  • Cetraxal, Ciloxan (ciprofloxacin)
  • Iquix, Quixin (levofloxacin)
  • Ocuflox (ofloxacin)
  • Vigamox (moxifloxacin)
  • Zymar (gatifloxacin)
  • Moxeza (moxifloxacin)

Ear Drops  These also contain fluoroquinolones.  Ask for another medication.

  • Cetraxal, Ciprodex (ciprofloxacin)
  • Floxin (ofloxacin)
  • Xtoro (finafloxacin)

Inhaled Fluoroquinolones  Could be prescribed for lung/ bronchial issues.

  • Quinsair (levofloxacin)

 

Pending FDA Approval Another fluoroquinilone is being considered.

  • Baxdela (delafloxacin)

 

Refer your provider to FDA updated warnings as of 7.26.16.  The warnings are located on this website!

Athletes should refer their provider to Mayo Clinic Recommendations for athletes.  The Mao Clinic has the following recommendations.

1.  Athletes should avoid all use of fluoroquinolone antibiotics unless no alternative is available.

2.  Oral or injectable corticosteroids should not be administered concomitantly with fluoroquinolones.

Here is this information in a PDF so you can print it out.

List of Fluoroquinolone Antibiotics in a table  Just click here to download

 

Adverse Reactions to Fluoroquinolones

Adverse Reactions to Fluoroquinolones
The following adverse reactions to fluoroquinolones have been reported. This should not be considered an exhaustive list of possible reactions, nor is it meant to be a diagnostic tool for fluoroquinolone toxicity. But, these are examples of the side effects from the drugs.  The list can be downloaded as a PDF on the link below.

Consult your physician if you think you are suffering from an adverse reaction to a fluoroquinolone.  Look up your record of drugs you have been prescribed including oral drugs, eye drops, ear drops and even inhalers.

•    Tendinitis
•    Speech/aphasia
•    Tendon rupture
•    Suicidal ideation
•    Ligament rupture
•    Seizures
•    Meniscus tear in knee
•    Visual/auditory hallucinations
•    Joint pain/popping
•    Non-allergy itching
•    Muscle atrophy/weakness/pain
•    Poor wound healing
•    Degeneration of spinal disks
•    Swallowing deficit
•    Peripheral neuropathy/nerve pain/nerve damage
•    Persistent gastric problems
•    Fatigue
•    Mouth sores
•    Dental pain
•    Food/chemical sensitivities
•    Facial pain/numbness
•    Dry/itchy eyes
•    Muscle twitching/involuntary spasms
•    Lack of tear production
•    Tremors
•    Visual changes
•    Insomnia
•    Retina tears
•    Brain fog
•    Vertigo
•    Anxiety/depression
•    Tinnitus
•    Impaired memory
•    Palpitations/arrhythmia
•    Palpitations/arrhythmia
•    Dysautonomia
•    High/low blood pressure

Click to get this list as a PDF download.

Adverse Reactions to Quinolones Table

Fluoroquinolones affect your PETS!

This class of antibiotics also affects your pets!  Veterinarians prescribe them for animals with infections when there are less serious drugs without these dangerous side effects.  So ask your vet if the drug they are prescribing is a fluoroquinolone.

  • Advocin, Advocid (danofloxacin)
  • Dicural, Vetequinon (difloxacin)
  • Floxasol, Saraflox, Sarafin (sarafloxacin)
  • ibaflin (ibafloxacin)
  • Marbocy, Zeniquin (marbofloxacin)
  • Orbax, Victas (orbifloxacin)

Flouroquinilones Cause C-diff

Consumer Reports February 2017 announced that one remedy for deadly hospital caused infections is to STOP prescribing flouroquinilone antibiotics such as Cipro and Levaquin.  These type of antibiotics are broad spectrum highly powerful drugs that are known to cause the infection commonly called C-diff.  This infection is a serious and in many cases deadly diarrhea.  Doctors often prescribe these antibiotics while a person is in the hospital and they can end up with an infection far worse than what they were checked in for.

In addition, the article also states that there are other serious side effects from these antibiotics.  Though the articles says that they are rare, that is not actually the case.  The FDA made note to all doctors to stop prescribing flouroquinilones for minor infections because the risk of the side effects far outweighs many of the reasons they are prescribed!

Unless you are in an extremely serious situation, avoid these drugs.  If you actually read the warning label that comes with them, you will see that they are for the Plague and Anthrax poisoning!

Link to the Consumer Reports article

Introduction

What we all should know:

  1. Antibiotics save lives and have been a vitally important tool in medicine to fight infection since they were developed in the 1930’s.
  2. Antibiotics have been overused, both in medicine and the raising of animals for food, leading to antibiotic resistance. This is currently well documented and slowly being addressed in both the medical community and farming.
  3. There are many classes of antibiotics. In the 1980’s the Fluoroquinolone class was introduced and quickly reports of serious side effects began to emerge. Over half of the Fluoroquinolone antibiotics have already been removed from the market due to fatalities and serious side effects.
  4. Medical professionals are currently unaware of the heightened warnings that have been added since 2008 including permanent and /or long term disabling side effects. Most drug side effects are transient and treatable. Fluoroquinolone side effects are long term and currently untreatable.
  5. In 2008 two black box warnings were added to the warning labels. This is the strongest warning the FDA provides for physicians.
  6. Fluoroquinolones including CIPRO, are associated with increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see WARNINGS).
  7. Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis.
  8. In 2013 an additional heightened warning was also added to the warning label for fluoroquinolones.

“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.”

The 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, of a change in sensation to light touch, pain or temperature, or sense of body position.”

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The side effects can stop you in your tracks!  There is no cure for the side effects!  Before you pop a pill to try to either kill an infection or prevent one, make sure you read everything you can if it is in the Fluoroquinolone class of antibiotics.  The most common are called Cipro and Levaquin.  Because they are broad spectrum antibiotics, doctors are prescribing them too often putting patients at risk for dangerous side effects.