Monthly Archives: August 2016

Publicizing Fluoroquinolone Warnings

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I have such mixed feelings about the FDA’s response to the November, 2015 Antimicrobial Drugs Advisory Committee meeting regarding fluoroquinolone safety. On one hand, I feel like they really did hear those who testified, and they not only listened, they responded in a way that showed that they listened. The FDA did what the Antimicrobial Drugs Advisory Committee recommended they do: they updated fluoroquinolone warnings to note that, “the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options.” They not only updated the warning labels, they updated the black-box warnings–the most severe warning a drug can have. I am truly grateful for the steps forward in acknowledging fluoroquinolone adverse-reactions, and I’m hopeful that the updated warning labels will lead physicians and patients to realize that fluoroquinolones are dangerous drugs with potentially devastating consequences.

I wonder though, what good is an updated warning label? In the post, Who Reads the Drug Warning Labels? I go over the problem of people not knowing what is on the warning labels. Are physicians going to read the updated warning labels? Are patients? Is anyone other than the “floxie” community going to realize that the warning labels have been changed?

I appreciate the action taken by the FDA–I really do–but are updated warning labels actually going to change anything? Will fewer people get injured and killed by fluoroquinolones? I certainly hope that a significant portion of doctors hear about the warning label changes, and stop prescribing fluoroquinolones, but, unfortunately, the FDA isn’t taking any major steps to make this happen.

The FDA has no plans to inform individual doctors about the recent warning label changes made to fluoroquinolone warning labels. Even though the black-box warnings, again–the most severe warning label a drug can receive, have been updated to note that fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions, the FDA is not going to tell doctors about the changes. No “dear doctor” letter will be issued by the FDA. They will not do a massive publicity campaign to let physicians or patients know that the warning labels have been updated. They know about the dangers of fluoroquinolones, and, in their own way, they acknowledge them, but they’re not proactively communicating what they know to patients or physicians.

Since the FDA isn’t going to issue a “dear doctor” letter, it will likely be helpful if we (the people in the fluoroquinolone toxicity community, and those who care about drug safety) give the information the FDA has released to our doctors, local hospitals, and media.

I encourage everyone reading this to please, please, please send this information (that is directly from the FDA) to your doctors, the media, your friends, your loved ones, and anyone else who you think may benefit from the information. People need to know how dangerous Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Factive/gemifloxacin are. In order for them to know how dangerous these drugs are, we need to tell them.

Please forward these FDA releases to those who need this information:

  1. 5/12/16 – Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections
  2. 7/26/16 – FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
  3. July, 2016 Drug Safety Labeling Changes

Since most people don’t actually click on links, I’m also going to copy and paste what the FDA notices said (feel free to share this post with anyone who needs the information too).

Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections:

AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient

ISSUE: FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) 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.

As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

See the FDA Drug Safety Communication for a list of currently available FDA approved fluoroquinolones for systemic use.

BACKGROUND: The safety issues described in the Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.

RECOMMENDATION: Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. 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. Patients should talk with your health care professional if you have any questions or concerns.

Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects:

SAFETY ANNOUNCEMENT

The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.

We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones).

Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course (see List of Currently Available FDA-approved Fluoroquinolones for Systemic Use).

Fluoroquinolones are antibiotic medicines that work by killing or stopping the growth of bacteria that can cause illness. They are FDA-approved to prevent or treat certain serious bacterial infections.

The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports* of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone (see Data Summary). We evaluated only reports submitted to FDA, so there are likely additional cases of which we are unaware. The side effects occurred within hours to weeks after starting the fluoroquinolone, and at the time we received the reports, the side effects had continued for an average of 14 months to as long as 9 years after stopping the medicines. Several cases reported that some side effects stopped or improved after discontinuation of the medicine; others reported the side effects worsened or continued.

We previously communicated about these safety issues associated with fluoroquinolones in May 2016. Additional communications about related safety issues associated with fluoroquinolones occurred in August 2013 (peripheral neuropathy) and July 2008 (tendinitis and tendon rupture). The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.

In addition to updating information in the Boxed Warning, we are also including information about these safety issues in the Warnings and Precautions section of the label. The Indications and Usage section contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI). The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines. We are continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed.

We urge health care professionals and patients to report side effects involving fluoroquinolone antibacterials and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

ADDITIONAL INFORMATION FOR PATIENTS

  • Fluoroquinolone antibiotic medicines are associated with disabling and potentially permanent serious side effects that can occur together in the same patient and should not be used to treat certain uncomplicated infections. These uncomplicated infections include acute bacterial sinusitis (ABS), acute worsening of bacterial chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI).
  • These side effects can involve the tendons, muscles, joints, nerves, and central nervous system, and can occur within hours to weeks after starting a fluoroquinolone medicine.
  • FDA has updated the Boxed Warning in the labels, added new warnings, and has revised the patient Medication Guide of all fluoroquinolone antibiotics.
  • Contact your health care professional immediately if you experience any serious side effects while you are taking your fluoroquinolone medicine.
  • Before starting a new fluoroquinolone medicine, inform your health care professional if you have previously experienced any serious side effects with another antibiotic.
  • Serious side effects involving the tendons, muscles, joints and nerves include:
    • Swelling or inflammation of the tendons
    • Tendon rupture
    • Tingling or pricking sensation (“pins and needles”)
    • Numbness in arms or legs
    • Muscle pain
    • Joint pain
    • Joint swelling
  • Serious central nervous system side effects include:
    • Depression
    • Hallucinations
    • Suicidal thoughts
    • Confusion
    • Anxiety
  • Other side effects include:
    • Abnormally rapid or irregular heart beat
    • Ringing or buzzing in the ears
    • Vision problems
    • Skin rash
    • Sensitivity of skin to sunlight
    • Headache
    • Trouble falling asleep
    • Fatigue
  • Read the patient Medication Guide you receive with your fluoroquinolone antibiotic prescriptions, which explains the benefits and risks of the medicine.
  • Talk to your health care professional if you have questions or concerns about fluoroquinolone antibiotic medicines.
  • We communicated safety information associated with fluoroquinolones in May 2016, August 2013, andJuly 2008.
  • Report side effects from a fluoroquinolone or any drug to your health care professional and the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

ADDITIONAL INFORMATION FOR HEALTH CARE PROFESSIONALS

  • FDA has approved label changes that reserve the use of fluoroquinolone antibacterial medicines when treating acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) for patients who do not have alternative treatment options.

  • FDA has also updated the Boxed Warning and the Warnings and Precautions sections of the labels and revised the patient Medication Guide of the fluoroquinolone drug class to describe the serious risk of multiple disabling and potentially irreversible adverse reactions that can occur together.

  • These adverse reactions primarily include tendinitis and tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects.

  • The adverse reactions can occur within hours to weeks after starting treatment with a fluoroquinolone medicine.

  • Discontinue the fluoroquinolone medicine immediately at the first signs or symptoms of any serious adverse reaction.

  • Avoid fluoroquinolones in patients who have previously experienced serious adverse reactions associated with fluoroquinolones.

  • Serious Adverse reactions of the musculoskeletal system and peripheral nervous system include:

    • Tendinitis/Tendon rupture

    • Muscle pain

    • Muscle weakness

    • Joint pain

    • Joint swelling

    • Peripheral Neuropathy

    • Serious Central nervous system effects include:

      • Psychosis
      • Anxiety
      •  Insomnia
      • Depression
      • Hallucinations
      • Suicidal thoughts
      • Confusion
    • Other adverse reactions include:

      • Exacerbation of myasthenia gravis
      • Prolongation of the QT interval
      • Hypersensitivity reactions/anaphylaxis
      • Photosensitivity/phototoxicity
      • Blood glucose disturbances
      • Clostridium difficile-associated diarrhea
    • Encourage patients to read the Medication Guide that they receive with their fluoroquinolone prescriptions.

    • FDA convened a public advisory committee meeting in November 2015 to discuss the risks and benefits of fluoroquinolone antibacterial medicines for the treatment of ABS, ABECB, and uncomplicated UTI. We also communicated safety information associated with fluoroquinolones in May 2016, August 2013, and July 2008.

    • Report adverse reactions involving a fluoroquinolone or any drug to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

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Levaquin/levofloxacin Warning Label Changes (Please see July, 2016 Drug Safety Labeling Changes for the other fluoroquinolone label changes:

BOX WARNING (revised)

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including LEVAQUIN®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:
    • Tendinitis and tendon rupture
    • Peripheral neuropathy
    • Central nervous system effects
  • Discontinue LEVAQUIN immediately and avoid the use of fluoroquinolones, including LEVAQUIN, in patients who experience any of these serious adverse reactions. Fluoroquinolones, including LEVAQUIN, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid LEVAQUIN in patients with known history of myasthenia gravis.
  • Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions, reserve LEVAQUIN for use in patients who have no alternative treatment options for the following indications:
    • Acute exacerbation of chronic bronchitis
    • Acute uncomplicated cystitis
    • Acute sinusitis

WARNINGS AND PRECAUTIONS

Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects (addition)
  • Fluoroquinolones, including LEVAQUIN, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting LEVAQUIN. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
  • Discontinue LEVAQUIN immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including LEVAQUIN, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Tendinitis and Tendon Rupture replaces Tendinopathy
  • Fluoroquinolones, including LEVAQUIN, have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting LEVAQUIN, or as long as several months after completion of fluoroquinolone therapy… Tendinitis and tendon rupture can occur bilaterally.
  • The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Discontinue LEVAQUIN immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including LEVAQUIN, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.
Peripheral Neuropathy (new sentences added)
  • Fluoroquinolones, including LEVAQUIN, have been associated with an increased risk of peripheral neuropathy. Cases of sensory…
  • …minimize the development of an irreversible condition…Avoid fluoroquinolones, including LEVAQUIN, in patients who have previously experienced peripheral neuropathy.

ADVERSE REACTIONS

  • The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
    • Disabling and Potentially Irreversible Serious Adverse Reactions (addition)
    • Tendinitis and Tendon Rupture (replaces Tendon Effects)

PATIENT COUNSELING INFORMATION

Serious Adverse Reactions
  • Advise patients to stop taking LEVAQUIN if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug. Inform patients of the following serious adverse reactions that have been associated with LEVAQUIN or other fluoroquinolone use:
  • Disabling and potentially irreversible serious adverse reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of LEVAQUIN and may occur together in the same patient. Inform patients to stop taking LEVAQUIN immediately if they experience an adverse reaction and to call their healthcare provider. (addition)
  • Tendinitis and tendon rupture replaces Tendon Disorders

MEDICATION GUIDE

What is the most important information I should know about LEVAQUIN?

Tendon rupture or swelling of the tendon (tendinitis).

  • Stop taking LEVAQUIN immediately and get medical help right away…
  • Worsening of myasthenia gravis (a problem that causes muscle weakness). Tell your healthcare provider if you have a history of myasthenia gravis before you start taking LEVAQUIN. (addition)

What is LEVAQUIN?

  • LEVAQUIN should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
  • LEVAQUIN should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections cause by a certain type of bacterial called Streptococcus pneumoniae.

Before you take LEVAQUIN, tell your healthcare provider if you:

  • have a disease that causes muscle weakness (myasthenia gravis); LEVAQUIN should not be used in patients who have a known history of myasthenia gravis.
  • have nerve problems; LEVAQUIN should not be used in patients who have a history of a nerve problem called peripheral neuropathy

How should I take LEVAQUIN?

Do not skip any doses of LEVAQUIN, or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless:

  • you have nerve problems. See “What is the most important information I should know about LEVAQUIN?”

  • you have central nervous system problems. See “What is the most important information I should know about LEVAQUIN?”

     

All help in spreading the word about these FDA warnings will be greatly appreciated!

 

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Updated Black-box Warnings for Fluoroquinolones

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In July, 2016, the FDA made significant changes to the warning labels for all fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, Noroxin/norfloxacin, and Factive/gemifloxacin). These label changes include black-box warnings for fluoroquinolones that state:

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including CIPRO®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:
    • Tendinitis and tendon rupture 
    • Peripheral neuropathy
    • Central nervous system effects
  • Discontinue CIPRO immediately and avoid the use of fluoroquinolones, including CIPRO, in patients who experience any of these serious adverse reactions. Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis.
  • Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions, reserve CIPRO for use in patients who have no alternative treatment options for the following indications:
    • Acute exacerbation of chronic bronchitis
    • Acute uncomplicated cystitis
    • Acute sinusitis

You can view all of the updated fluoroquinolone labels HERE.

These updated black-box warning labels are HUGE steps in the right direction. The FDA is acknowledging, in a highlighted black-box section of the warning labels, that fluoroquinolone adverse-effects can be serious, irreversible, and disabling. They’re also acknowledging peripheral neuropathy and central nervous system effects, in addition to the adverse-effects on tendons, in the black-box warning. Additionally, the black-box warning states explicitly that fluoroquinolones should not be used for treatment of patients with chronic bronchitis, uncomplicated cystitis (I wish they would have said “urinary tract infections” instead of “cystitis” as they did in the hearings and preliminary documentation), and sinusitis, unless there are no alternative treatment options.

If this updated black-box warning had been in place when fluoroquinolones were first introduced to the market (in the 1980s and 1990s), many people would have been saved from being “floxed.” If these warnings had been in place when fluoroquinolones entered the market, or even when people started screaming about the significant damages and injuries caused by fluoroquinolones, perhaps more doctors would be aware of the dangers of these drugs, and they would be used more appropriately (only in life-or-death situations where there are no alternatives available). Currently, unfortunately, most people are not aware of the devastating effects of fluoroquinolones. Hopefully this updated black-box warning label will enlighten both patients and physicians about the serious and severe dangers of fluoroquinolones.

Prior to this update, the black-box warning for Cipro (and other fluoroquinolones) stated:

Fluoroquinolones, including CIPRO®, are associated with an 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).

Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis (see WARNINGS).

This 2008 black-box warning was hard fought for, as both Bayer and Ortho-McNeil-Janssen (a subsidiary of Johnson & Johnson) wanted to bury the risks of tendon ruptures in small-text embedded in the warning labels, rather than highlighting the increased risk in a black-box warning. It was only after Public Citizen sued the FDA that this black-box warning was added to fluoroquinolone warning labels.

Though the old black-box warning was a significant victory at the time, it left much to be desired. The statement that, “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,” suggests that those who are under 60 years of age, not taking corticosteroid drugs, and who have not had kidney, heart, or lung transplants, can safely take fluoroquinolones. Though it is also noted that the risk of tendon ruptures is increased for people of “all ages,” it is common to hear of people being told that they wouldn’t have problems with fluoroquinolones because only older people, or people with myasthenia gravis, are at risk for experiencing adverse-effects. This simply isn’t true, as there are thousands of people who have been hurt by fluoroquinolones who are under the age of 60, do not have myasthenia gravis, who are not on corticosteroid drugs, and who have not had an organ transplant.

The old black-box warning gave people (both patients and physicians alike) the impression that fluoroquinolones are only unsafe for certain, small sections of the population. The truth is, fluoroquinolones can cause devastating, severe, disabling adverse-reactions in people who are young and old, strong and weak, fit and out-of-shape, and, at this time, there is no way to determine who will have an adverse-reaction and who won’t. There are almost certainly factors that predispose some people toward having devastating adverse-reactions to fluoroquinolones while others seem to be able to take fluoroquinolones without problem, but we don’t know what those predispositions are. No one knows if people who have latent autoimmune or endocrine system disorders, or who have MTHFR genetic mutations, or who are G6PD deficient, or who have leaky gut, or who have been exposed to heavy metals, or any other potential risk factor, are more succeptible to fluoroquinolone adverse-reactions than anyone else. There is a dice-roll, a pull of the Russian roulette trigger, every time ANYONE takes a fluoroquinolone because NO ONE knows what the real risk factors are, or even how frequent/rare adverse-reactions are. I wish that it was explicitly said on the fluoroquinolone warning labels, preferably in the black-box warning, that risk-factors are currently unknown and that everyone who takes fluoroquinolones is potentially at risk for experiencing disabling adverse-effects.

I also wish that it was noted in the black-box warning that adverse reactions to fluoroquinolones can be delayed for weeks, months, or even years after administration of the drugs has ceased. And I wish that people were warned that ceasing administration of the drug may not stop the adverse-reaction, and that the symptoms of fluoroquinolone toxicity can continue long after the drug “should” be out of one’s system.

I also wish that the danger of co-administering fluoroquinolones and corticosteroid drugs had stayed in the black-box warning, and I wish that the contraindication of NSAIDs and fluoroquinolones was noted in the black-box warning.

I wish that “cystitis” was changed to “urinary tract infection,” or that they were both mentioned as ailments for which the use of fluoroquinolones is not appropriate unless there is no alternative. I also wish that prostatitis and travelers’ diarrhea were added to the list of ailments for which fluoroquinolones should not be used unless there is no alternative.

Perhaps the next iteration of the black-box warning on fluoroquinolones will note those things. I wish I, and my doctor, had been warned more thoroughly about the dangers of fluoroquinolones before she prescribed them to me, and before I took them. Hopefully the updated black-box warning label will help physicians and patients to realize how dangerous fluoroquinolones are, and will keep many people from getting “floxed.”

Though the updated black-box warnings still leave a bit to be desired, they are a HUGE step in the right direction. Acknowledgement from the FDA that fluoroquinolone adverse-effects can be irreversible and disabling, and that they should not be used to treat many common conditions unless there are no other treatment options available, is very big news, and it should be celebrated. We are making progress, and hopefully fewer people will be hurt by fluoroquinolones because of these black-box warning updates.

 

 

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First Do No Harm – By Barbara Arnold

do-no-harm

The following was written by Barbara Arnold and published in a magazine aimed toward ex-pats living in Spain. When Barbara sent it to me she said, “If it saves one person from taking this poison, then I will be happy. I am trying to get it translated to Spanish so I can send it to the Spanish papers here.
I urge every floxie that is well enough to try and get articles published in any magazine local paper etc. It’s certainly helped me focus my anger in a positive way, and maybe eventually it will become better known about.”

I also encourage all of my floxie friends to write something like what Barbara wrote below. It is important to focus your anger in a positive way, and it is even healing. Writing, advocating, and helping others through this mess have been vital parts of my healing process. I suspect that those things can be healing for other people as well, and I encourage each of my floxie friends to write, advocate, and help others in whatever way you feel comfortable. 

Thank you, Barbara, for speaking out and passionately advocating for those in medicine to think about the Hippocratic Oath when they prescribe fluoroquinolones!

FIRST DO NO HARMWritten by Barbara Arnold.

Before Doctor can practice they have to take “The Hippocratic oath”, First do no harm. Unfortunately harm is being done to hundreds of thousands, maybe even millions of people across the world by Doctors prescribing antibiotics from a group called FLUOROQUINOLONES.

For me, it all started nearly 2 years ago when I went to the Doctor with bronchitis. I had no idea then that my life was about to change, in the most awful drastic way possible and that for the next two years to date I would still be  suffering from the debilitating side effects from ciprofloxacin an antibiotic from the group called FLUOROQUINOLONES. At the same time I was given cortisone injections the result of which was like a bomb going off in my body. It started with searing pain in my Achilles tendons, at the time I stupidly believed that it was caused by changing my high heeled shoes to low heels and then walking to far. I had no idea that my body was being POISONED by a treatment for a simple thing like Bronchitis. I had great difficulty walking but I believed it would soon get better. HOW WRONG I WAS. 

I had mentioned to the nurse who was administrating the cortisone injection that I was having trouble walking, and did he think it was anything to do with the injections. He told me it couldn’t be as cortisone is an anti-inflammatory. At this point I did not connect the dots. I later found out these drugs are contra indicated to anyone over 60yrs and even worse especially alongside cortisone injections. Fluoroquinolones leach magnesium from the cells and as you get older you have less magnesium to begin with. The pain got worse to the point I ruptured a tendon causing a bruise the size of “England” on the inside of my right leg and I could   barely walk a few yards. At the same time I started to get Chronoc Fatigue to the point where I could hardly keep my eyes open. I had dizziness and balance problems.

For the next three months and many visits to my Doctor, I eventually saw a Rheumatologist who diagnosed my condition as “side effects of ciprofloxacin”.

From that point onwards I started to do my own research on Fluoroquinolones. The results were MIND BLOWING I found out that these antibiotics were being used for simple bladder infections, bronchitis and sinus infections. This was the equivalent of using a sledge hammer to kill a fly. There are many other safer antibiotics that could be used without the devastating side effects that can be caused by Fluoroqinolones. I was told I was a RARE CASE and that my Doctor had never heard of this before. Unfortunately this is totally untrue, as the symptoms of fluoroquine poisoning are vast and in some people the reaction does not occur until months later. Therefore a lot of misdiagnosis is going on. Here are some of the symptoms that can occur but are not limited to, weeks or even months later.

MUSCULOSKELETAL DAMAGE WITH DEGENERATION OF CARTILAGE AND TENDONS. DAMAGE TO THE MITOCHONDRIA (the power cells that give us energy} DETATCHED RETINAS, NEURO PROBLEMS, ANXIETY, PANIC ATTACKS. PERIPHERAL NEUROPATHY IE, BURNING, DAMAGED NERVES,, PAIN, OXIDATIVE DAMAGE IN MAMMALIAN CELLS, CELL DEATH, INSOMNIA, DIFFICULTY BREATHING, PALPITATIONS, SKIN RASH, VOMITING, HIVES LOSS OF MUSCLE STRENGTH, BRAIN FOG. These are just a few of fluoroquinolone poisoning symptoms. There are many many more.

As things got worse I had to result to using  a wheelchair as it was extremely painful to walk. As well as the pain, my legs felt like I was dragging along lead weights. During the months that followed I had various blood tests which showed NOTHING apart from high ferritin levels. I was referred to another Rheumatologist who treated me more or less with contempt as no test she did showed anything wrong. I had  learned that there was a BLACK BOX WARNING in America about this group of antibiotics and when I told her about this, that the Black Box Warning is the highest warning you can get in America, she scoffed at me and declared “This is Spain not America.”  This kind of arrogance and ignorance is allowing others to suffer in the most devastating ways. Subsequently, some 18 months later, the Food and Drug Administration has just issued an advisory to ALL DOCTORS IN THE UNITED STATES, to cease using these dangerous drugs to all patients unless it is a life or death situation.

I have spent thousands of pounds in natural supplements trying to cure myself as Doctors do not have any answers. However there are some Doctors willing to listen now as they or some-one in their family have been effected. by this group of chemotherapy drugs. YES they are chemo drugs because they destroy good cells as well as bad. They do damage down to the very DNA and in some people they leave permanent nerve damage. I am presently seeing an integrative Doctor who is also a Medical Doctor. He is in Marbella and I have to travel 5 hours to see him. I have no choice if I want to recover. The medical health care system here poisoned me and now I have to heal myself with all the costs that, that incurs.

I fully understand that Doctors do the best they can and cannot be expected to know the side effects of every drug they prescribe, but this group of drugs are completely different as they are one of the most dangerous drugs on the market, It was the responsibility of the  health representatives to inform Doctors of this. They were negligent in their duty of care and because of that I, and many other’s have been sentenced to years of suffering. This has been known about since the 1970’s. The attitude of the pharmaceutical companies beggars belief. It is only now with the event of the world-wide web that this is becoming common knowledge   If you think you have been effected by any of these drugs go to http://www.floxiehope.com. There is a mine of information there from fellow sufferers and Doctors who are now beginning to take notice. I urge every-one that reads this to be very very careful that you are not prescribed any antibiotic from this group namely ….CIPROFLOXACIN, LEVAQUIN/LEVOFLOXACIN, AVELOX/MOXIFLOXACIN OR FLOXIN/OFLOXACIN.

To conclude, not everyone that takes these drugs suffers the side effects initially but eventually maybe years later this has been known to happen. There are likely genetic factors that make some people  more susceptible to suffer adverse reactions to fluoroquinolones than others. Human bodies are complex and how a drug reacts in a human body is difficult to predict. I just wish Doctors took their  “Hippocratic Oath” more seriously and FIRST DO NO HARM.

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August catch-up

I haven’t written a post for Floxie Hope in a while, and I apologize for that!

A lot has taken place in both my personal life and in “floxie” news since I last posted on this site. My thoughts on all matters personal and professional are a bit jumbled at the moment, so this post is just going to be a bit of a hodgepodge.

First and foremost, the FDA announced the warning label changes for fluoroquinolones. Please see “FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects” for more information about this. The CBS News article, “Class of antibiotics gets stronger warning due to dangerous side effects” is a succinct article to show your loved ones too. I will write more about this important update shortly–just as soon as my life calms down. If you want my quick opinion–I think it’s a huge step in the right direction and I hope that it will keep many others from getting hurt by fluoroquinolones.

I haven’t written more extensively about the warning label changes because I’ve been busy in my personal life. The main thing I’ve been busy with is…

I got married!

Wedding Lisa Mark

The wedding was beautiful and perfect and I couldn’t be happier! 🙂

When I first got floxed I was scared that I wouldn’t ever be able to find love and acceptance. Those fears faded with time and healing, and this past weekend I was able to marry the love of my life, Mark. It was an incredible day and I look forward to years of happiness with my amazing husband!

In marrying Mark, I not only gained a wonderful husband, I also gained many new family members, including three amazing step-kids. Mark’s kids live in Michigan with their mom most of the time, but they have been staying with us in Colorado for the last several weeks. They’re wonderful kids, and I enjoy them immensely! I’m not sure if it makes me a good or bad step-mom to note this next thing, but, man, keeping up with kids is difficult! I’m semi-exhausted most of the time – and that’s with healthy, happy, good kids, and a fully recovered (from FQ toxicity) body and mind. People who parent while sick (with FQ toxicity or any other illness), or who parent sick kiddos, have my undying admiration and respect. I don’t know how you do it, but you do, and you deserve props and recognition for the effort involved.

Even though I’m semi-exhausted from wedding planning and execution, as well as from keeping up with the kids, I think that it’s a normal level of exhaustion for a 36-year-old doing what I’m doing. I have all the “spoons” I think I would have if I had never taken ciprofloxacin. I was more exhausted more frequently when I was going through the depths of fluoroquinolone toxicity. Over time (and I think that supplementing iron helped me immensely – though I don’t supplement it regularly any longer), my energy levels have returned to normal. I hope that my noting of getting my energy back helps others to have hope that their energy can return too.

Thank you to all in the floxie community who wished me well on my nuptials on facebook! It is great to have your support and well-wishes! I consider many in the floxie community to be friends, and each of you are appreciated!

If anyone reading this feels inclined, it would be wonderful to read a post about how fluoroquinolone toxicity has stolen your energy and/or ability to parent. If you want to write about that, Hormones Matter is always looking for new writers, and it’s a good site to tell personal health stories/journeys. Here’s info on how to write for Hormones Matter –  https://www.hormonesmatter.com/write-for-hormones-matter/. If you have another topic that you’d like to write about for Hormones Matter, feel free to reach out about anything health-related that is on your mind.

I have been referring people to this post – https://floxiehope.com/2015/10/12/im-floxed-now-what/ and this site – http://fluoroquinolonethyroid.com/ – often lately. Please check both out!

Those are my updates for the moment. Sorry for this being such a random and disjointed post! I hope that you all are finding help, hope, information, and recovery!

Hugs,

Lisa

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