Tag Archives: antibiotic side effects

Publicizing Fluoroquinolone Warnings

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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In Memory of Dr. David Flockhart

On November 26, 2015, the floxie community lost Dr. David Flockhart, M.D., Ph.D., a beloved physician and researcher who passed away at his home in Indianapolis, surrounded by his family, after a year-long struggle with an aggressive form of brain cancer called glioblastoma multiforme.

Dr. Flockhart was a beacon of hope for many people dealing with fluoroquinolone toxicity. He acknowledged the harm done by fluoroquinolones, and was able to help hundreds of floxies with both his vast knowledge of the harm that fluoroquinolones do, and personalized treatment protocols. His floxed patients loved him for his caring bedside manner and he was considered by many to not only be a physician, but also a friend. He will be missed by many.

A lovely obituary for Dr. Flockhart can be found here – http://sideeffectspublicmedia.org/post/remembering-david-flockhart-md

From the above obituary, it is noted that, “Over the course of his career, he (Dr. Flockhart) became one of the world’s foremost authorities on drug interactions and reactions. Patients from around the nation sought his opinion when other doctors insisted they were simply imagining or inventing sometimes painful and debilitating side effects.”

Dr. Flockhart spoke out to the media about adverse effects of fluoroquinolones. He noted in the PBS Newshour Frontline expose, “Certain Antibiotics Spur Widening Reports of Severe Side Effects” that, “You don’t use these big guns, if you like, for killing mosquitoes, for little limb infections. You should use them appropriately for big infections that they’re useful for.”

Also, reported in the Washington Post article, “It Pays to Read the Warnings When You Open Up a Prescription,” “’The vast majority of physicians don’t even know how to report side effects to the FDA. They don’t have a clue,’ says David Flockhart, head of the Department of Clinical Pharmacology at the Medical School of Indiana University. ‘And there’s a psychological resistance to believing that what they’ve done has hurt.'”

Dozens of other quotes from Dr. Flockhart about fluoroquinolones can be found throughout the internet.

Dr. Flockhart didn’t only focus on fluoroquinolone toxicity. His career in research and medicine had many facets. He was a pioneer and leader in the field of pharmacogenetics, the understanding of how an individual’s genes affect his or her response to drugs. Additionally, “He published more than 250 articles, reviews, and book chapters, and was a member of many prestigious professional organizations. He received numerous awards, including the Leon I. Golberg Memorial Lecture Series Award from the University of Chicago, the Rawls-Palmer Award for Progress in Medicine from the American Society for Clinical Pharmacology and Therapeutics, and the Nathaniel T. Kwit Memorial Distinguished Service Award from the American College of Clinical Pharmacology.” (quoted from his obituary)

Candy Markman, a past board member of Amnesty International’s U.S. section and a personal friend of Dr. Flockhart noted that, “He was an enormously compassionate human being who really respected other human beings.”

My condolences to Dr. Flockhart’s family, friends, patients and associates. He is missed.

 

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FDA Hearing – Victory for Victims of Fluoroquinolones

FDA Hearing Fluoroquinolones

On November 5, 2015, a meeting was held at the FDA’s White Oak campus in Silver Spring, Maryland, for the Antimicrobial Drugs Advisory Committee to discuss, “the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.”

Hundreds of victims of fluoroquinolones from all over the U.S. and Canada came to the meeting to tell their stories of fluoroquinolone toxicity, and the pain and disability that fluoroquinolones brought to their lives. 35 victims and advocates had the opportunity to speak directly to the committee.

The stories of pain, disability, and death caused by Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin were heart-felt and poignant. The pain that these drugs have caused was noted by all those in attendance–including fellow victims, supporters of victims, the media, and the committee.

After deliberation and discussion, the FDA committee decided that the risk and benefits of systemic fluoroquinolone use for treatment of sinus infections, bronchitis in those with COPD, and uncomplicated urinary tract infections, are NOT sufficiently described in the warning labels for fluoroquinolones. The committee voted almost unanimously in favor of changing the warning labels. WE WERE HEARD! This is a HUGE step in the right direction!

FDA Votes1

The committee is now going to recommend that the FDA update the warning labels to better address the risks and benefits associated with fluoroquinolones. You can read in past posts about how the briefing for this meeting acknowledged that fluoroquinolones are no better at treating the conditions in question than placebos (https://floxiehope.com/2015/10/20/the-fda-notes-that-fluoroquinolones-are-no-better-than-placebos/) and how fluoroquinolones cause a constellation of disabling symptoms (https://floxiehope.com/2015/10/25/an-official-name-fluoroquinolone-associated-disability-fqad/). The entire brief can be read HERE.

An almost unanimous vote by the committee is a HUGE step in the right direction and it is a huge VICTORY that should be celebrated!

THANK YOU to all who came to the meeting testify or to support! You are all appreciated!

In a few days (maybe weeks) the entire meeting will be available to be viewed online. I suggest checking in at the FDA’s web site in a couple of weeks – http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/ucm424449.htm. (I’m not sure that that’s the correct link. If it’s not, I apologize.)

Here are a couple of videos of the testimony provided:

Nicole Delaine:

Michael Kaferly:

More information about Michael’s journey to tell his story can be found at – http://thencamemichael.com/2015/11/08/david-vs-golliath-michaels-fda-testimony/

Here is what I (Lisa Bloomquist) said:

My name is Lisa Bloomquist. I flew in from Denver in order to testify about the damage that ciprofloxacin did to me, and to encourage you to cut the approved uses for fluoroquinolones so that they are only used in life-or-death situations.

In 2011 I took ciprofloxacin to treat an uncomplicated urinary tract infection. I experienced the following symptoms after taking it:

1. Hives all over my body
2. Weakness in my legs to the point that I could barely walk
3. Tightness and pain in my tendons
4. Brain fog
5. Memory loss
6. Autonomic nervous system dysfunction
7. Fatigue
8. Anxiety, fear and other central nervous system symptoms

I was sick for 18 months of my life in my early 30s because of a drug I took to treat a simple urinary tract infection. I have gotten rid of subsequent uncomplicated UTIs with d-mannose and my immune system. It is NOT APPROPRIATE for drugs that are as dangerous and consequential as ciprofloxacin and the other fluoroquinolones to be prescribed to treat simple infections that can be cured with more benign methods.

You will hear the testimony of people who have had much worse reactions than I did. You will hear from people whose lives have been destroyed by fluoroquinolones. The adverse effects of these drugs are severe.

Janssen and Bayer lawyers claim that there is no mechanism for the constellation of symptoms described today. They are wrong.

Fluoroquinolones cause:

  1. Mitochondrial damage which starts a vicious cycle of oxidative stress and further mitochondrial damage. 
  2. Acute fluoride toxicity.
  3. Fluoroquinolones chelate vital minerals from cells, including magnesium and iron. These minerals are necessary for hundreds of enzymatic reactions. 
  4. Fluoroquinolones cause a downgrading of GABA receptors and essentially throw people into protracted benzodiazepine withdrawal.
  5. Fluoroquinolones cause a massive histamine release and mast cell activation. 
  6. They cause collagen synthesis disorders.
  7. They cause microbiome destruction.
  8. All topoisomerase interrupting drugs cause epigenetic damage. They are chemo drugs. Fluoroquinolones should be treated as chemo drugs. They should only be used in life-or-death situations. 

I know these effects, and I can refer you to the studies documenting them. Why don’t you?

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Sherry Reiver:

Good afternoon chair and committee people,

I am so angry after hearing the drug companies but I have my speech written already!

My name is Sherry Reiver and I am 64 years old. I have been sick from FQs in all forms since I was 43. I moved from NY to Charlotte 10 years ago and for 21 years it is difficult to find a dr that will validate that FQs has destroyed my health and life. Each year that goes by, it’s harder for Drs to believe that these affects last so long. Over two years ago during a surgery at Duke against my consent, Floxin soaked GELFOAM PLEDGETS and steroids were placed in my head and I am 200x worse. Lets not kid ourselves, TOPICALS are just as dangerous as any FQs and the Topicals need to be INCLUDED not EXCLUDED from that PN warning the FDA came out with in August of 13.


The perils of the topicals used on children for ear and eye infections should cause great concern and should be researched as well. What are these drugs doing to their little brains and bodies?


This is a bittersweet day for me. Four years ago today, my 93 year old dad died. He FELL at home and was taken to the hospital by a neighbor. By the time my husband and I arrived in Florida, my dad had no idea who we were. They THOUGHT he had pneumonia so they IV’d him with Levaquin. It turned out that he did NOT have pneumonia but he continued to hallucinate for 6 weeks and then died. He was sharp as a tack before Levaquin dripped into his body. He did have an aortic aneurysm for many years which was being watched but it ruptured on November 4th. I would have never connected the AA with FQs until I read this research paper dated October 5th 2015. So here is another RARE side effect that can occur, which it did in my dad’s case. How many others have died from AAs and had taken a FQ drug? It took 10 years for this report to come to light. Was the FDA aware of this research from Tawain?

Do you know that after each cystoscope, Urologists hand out the gift of one Cipro, thank you Bayer, for the “just in case ” scenario? I know this for a fact. Cipro is also given out FREE at pharmacy so therefore it is prescribed more.


Three minutes does not allow me time to talk about my own health issues but understand there are many but Dr. Boxwell’s slides just showed them. We have flares which come and go at the whim of these drugs. It’s the drug that keeps on giving even years later. It has no time constraints, it holds no barriers. Doctors are clueless. We get no warnings, doctors DO NOT report our concerns and they dint read the labels themselves!

NOW EVERYONE, THIS IS THE PART I WAS UNABLE TO READ AS I READ TOO SLOWLY AND MY 3 minutes were up!!!


We are all disabled in different degrees. Don’t judge a book by its cover. I miss my life, i miss reading , I miss being productive and I miss my salary. What I have is not the “aging process” as some Drs have told me, but FQ Toxicity.


Unfortunately there are millions of people who have not connected the dots because they don’t expect an antibiotic to do such harm. Some of these people have died and their families will never know that the FQs were the reason.


Drug reps are NOT the ones who should be educating the Drs on the uses of ANY drugs. The drug companies need to come forward with information they are hiding. Their studies are flawed. PLEASE STOP THE MADNESS of these drugs being handed out so indiscriminately.

Although I am not asking you to ban these drugs, I personally, if on my deathbed would rather die than experience any worsening of my life as it is now.
Thank you for your time. I waited 21 years to be heard!

Rachel Brummert (President of the Quinolone Vigilance Foundation):

FDA_november_rachel02

Note: Rachel’s slide presentation referenced is available HERE.

Good afternoon. My name is Rachel Brummert and I am the Executive Director of the Quinolone Vigilance Foundation. Neither the foundation, nor I, have any financial ties to this hearing.

[SLIDE ONE: Fire pictures/pictures of pills]

Fluoroquinolone antibiotics are incredibly powerful with the capability to save lives when used as a treatment of last resort for life-threatening bacterial infections like anthrax. These antibiotics have equal power to destroy lives when they are prescribed for routine infections like sinus infections and UTIs that don’t need their strength. Just as it is irresponsible to squelch a kitchen fire with the defenses we would mount against a wildfire, likewise, it is reckless to use a fluoroquinolone antibiotic to squelch a routine infection. There are safer, effective antibiotics for the treatment of routine infections in the event that an antibiotic is even necessary.

[SLIDE TWO- Pictures of my ruptures/scars]

I am living proof that the risks in using a fluoroquinolone to treat a routine infection far outweighs the benefits. In 2006, I was prescribed Levaquin for a sinus infection. Within weeks, my achilles tendon ruptured in a parking lot, the first of ten tendon ruptures I’ve suffered over nine years.

[SLIDE THREE- List of my adverse reactions with ICD9 codes]

A first-line of defense antibiotic like Amoxicillin, would have resolved my sinus infection, and I would not have been exposed to the relatively disproportionate risks of known fluoroquinolone-associated injury, which includes a progressive neurodegenerative disorder, from which I will never recover.

With just one prescription, a once-healthy wage-earner, parent, or grandparent – just like you, just like me – can no longer enjoy a reasonable quality of life and now lives with lifelong risks for the development of an illness that is life-threatening.

[SLIDE FOUR- HOW CAN THE FDA HELP?]

What can the FDA do to protect patients from profound, preventable harm? A preventable problem is a fixable problem. The FDA is responsible for protecting and promoting public health through the regulation and supervision of a wide variety of consumer products including prescription medications. Fluoroquinolone antibiotics are causing widespread disability and their overuse is also a contributing factor in the antibiotic resistance epidemic. Antibiotic resistance is such an important issue that there is a White House objective to do something about it. If fluoroquinolones are being prescribed for routine infections which don’t need their strength and they are disabling otherwise healthy patients, and their overuse is leading to an international epidemic, the answer is clear: The FDA must apply its highest level of scrutiny, regulation and surveillance of fluoroquinolones to achieve this shared goal.

Thank you for your time and consideration and for holding this very important meeting.

Linda Livingston:

I have 3 minutes to tell you about my side effects from Cipro, given to me for a simple UTI. I could take an hour trying to describe the two nightmarish months where my breathing was so suffocating I gasped for every single breath. Each night I had to take a pill to sleep and only got an hour if I was lucky. And each night before I took the pill I prayed I wouldn’t wake up. Words cannot describe the rage I feel for the torture I have endured.

I could tell you about the damage to the nerves around my neck that make it feel numb at times and like I am being choked at other times. I could tell you about the horrific olfactory nerve damage that made everything thing in the world asphyxiate me, making me a virtual shut in. I could tell you about my pericardial effusion, blurred vision, terrifying light show, excruciating back pain worse than when I had cracked ribs, or being bedridden for a month and having to have food and non-fluoridated water dropped off, and laundry picked up. I could tell you about my numb fingers and toes, constant bladder pressure, ravaged GI system and 32 pound weight loss in two months, with muscle waste and extreme weakness. There is the swelling over the ulnar nerve, the spasming uncontrollable fingers, the light sensitivity, sound sensitivity, newly acquired food sensitivities, electrical zaps in my knee and arm, popping in my spine and hip, extreme anxiety, depression, crying everyday for 8 months, and suicidal thoughts.

I could tell you about my fears —that my breathing will never again be normal; that my eyes will not improve or even get worse; that my DNA is permanently damaged or my fears surrounding the links to several eye diseases, ALS, Parkinsons and Altzheimers. No one deserves to have their life devastated for a simple UTI!

My life is so different from 9 months ago. I cannot work and worry about how I will pay rent, let along treatments which are not covered by insurance. I can’t meet friends for dinner or happy hour. I have not enjoyed a cup of coffee or glass of wine since January. I can’t exercise like I used to. (I was in incredible shape before this.) My diet is so restricted that there are few places I can go. I am tired all the time, and my anxiety prevents me from doing many things I used to do. My passion is theatre and I may never be able to perform again. There is little joy.

First we are poisoned, then we are left to fend for ourselves because doctors are mostly oblivious to any of the side effects. They are not reading labels or warnings. We are treated with ridicule and derision by the medical community, and then we are financially devastated as well.

If another country did this to us, they would be called war crimes. The pharmaceutical companies have known for decades about the hideous side effects. The FDA has allowed them to inappropriately market these drugs for simple infections. There was recently a GM car recall because of 78 deaths. These drugs may be responsible for up to 300,000 deaths (not to mention all the life altering side effects.) We are not just figures on a share-holders statement. We are people who have been tortured and have our lives decimated. So, why are you even still discussing it at this point?

Linda Landmon:

FullSizeRender

My name is Linda Landmon. I’m here today with my husband David, we’re from Dallas Texas and I’m 58 years old.

In 2009 we bought our dream home that we planned to retire in. I had been self employed for 9 years working from home. I was an avid bicycle rider, I enjoyed swimming, entertaining , traveling, spoiling our 2 grandkids and I even had a personal trainer coming to my house twice a week.

Life was good !

But then things changed –

December of 2011 I was diagnosed with a kidney stone.

My Urologist gave me Levaquin “samples ” with no information on the medication or the side effects it may cause. My urine culture was negative for infection.

April of 2012 my Urologist gave me Cipro after a Lithotripsy , again I had no infection.

December of 2012 my Urologist surgically removed my kidney stone and again gave me Cipro. I had no infection this time either.

One week later, January 2013 I went to the ER with Kidney stone pain and I was given one IV of Levaquin and pain medication. My urine culture was negative for infection.

10 days later I went back to the ER with kidney stone pain and I was given 4 bags of Levaquin AND a prescription for Levaquin to take for 10 more days. My urine culture was negative for infection.

Since these medications I’ve been diagnosed with Peripheral Neuropathy, ringing in the ears, high anxiety , a torn rotator cuff, a torn meniscus , which has resulted in needing a total knee replacement , spinal stenosis and tendon damage in my foot. This has all led to depression and I’ve basically become a recluse. For me to speak here today is HUGE !

I’ve had numerous MRI’s , X-rays, steroid shots, I’ve been prescribed, Celebrex , Neurontin, Lyrica, Tramadol and Xanax.

I have a walker, crutches, a leg brace various boots and supports for my foot.

These drugs are prescribed way too often without any proof of infection. I know because it happen to me , FIVE TIMES.

Fluoroquinolones are the only antibiotics I’ve found that carry a Black Box warning and it hasn’t stopped doctors from passing them out like candy.

I didn’t have Anthrax, the Plague OR an infection. I had a kidney stone.

Christabelle Cruz Chajon:

Good afternoon Chair and Committee Members, my name is Christabelle
Chajon. I am 35 years old and live in Washington DC with my husband and
5 year old daughter.

Prior to February 2014, I was loving life. I was healthy and active, and on
no medications. I was a full-time mom with the ability to also work part-time
from home, and enjoyed exercising, hiking, reading, and playing music.

In February 2014, I went to the doctor for a lingering cough. I was
diagnosed with bronchitis and given a 5 day course of Levofloxacin. I
asked at the pharmacy if there were side effects, and was told they were
rare and that tendon damage was only a concern for elderly patients. After
the last pill, I woke in the middle of the night shaking, unable to speak, and
numb from head to toe with my heart racing, and my husband rushed me to
the ER. This happened 3 more times within 6 months after taking
Levofloxacin, and each time I was discharged with nothing more than heart
palpitations.

I also developed many other symptoms including insomnia, intense muscle
and joint pain and weakness, digestive issues, vertigo, fatigue, painful
neuropathy, cognitive impairment, and extreme chemical sensitivities. This
translated into changing my life completely – having to cancel planned
family trips, being unable to carry my daughter when she needed me,
falling asleep unexpectedly while caring for my daughter, being unable to
exercise and enjoy hobbies let alone walk and get out of bed some days.
Food that I ate with no problems before made me sick, and I also lost over
10% of my weight, which is attributed to my body no longer digesting fats
and proteins. Many of these symptoms I still struggle with today, and my
quality of life has declined tremendously. I do not work, and the proper
care and treatments I need are a financial burden on my family. It has
been a frightening struggle to say the least.

But what is most frightening is that most doctors fail to realize that
fluoroquinolones can cause this type of systemic damage. In my search for
help, I even encountered one doctor who was insulted that I considered
that my symptoms were caused by levofloxacin. How can that be when the
connection was obvious as I went from perfectly healthy to unable to get
out of bed and function normally most days?

I joined the Fluoroquinolone Toxicity Group online in the spring of 2014,
which at the time had around 2000 members, all who have suffered from a
constellation of symptoms. That number has more than doubled since
then. It is evident that Fluoroquinolone Associated Disability is not rare.

And per today’s meeting’s briefs, it’s been concluded that antibiotics don’t
make much of a difference on uncomplicated conditions such as sinusitis,
bronchitis, and UTIs; yet, potent fluoroquinolones are being prescribed for
them. The doctors who are inappropriately prescribing these drugs for
simple infections are either unaware of these warnings, or are not taking
them seriously. Limiting the indications to only include serious and lifethreatening
infections, full disclosure to patients about these drugs, and
adding FQAD to the warning labels of fluoroquinolones are absolutely
necessary to stop the countless number of lives damaged and even lost to
these drugs.

If you would like to share your testimony on this site (to archive it, for search engines to find it, or just because you want to) please send it to me through the Contact link above. I am happy to post any and all testimony in any form.

Thank you again to everyone who came to the meeting yesterday! It truly was a huge victory! Great job, everyone!!!

 

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Dr. Perlmutter Speaks About the Microbiome and Advocacy

Yesterday I went to a wonderful event at a Natural Grocers where Dr. David Perlmutter spoke about the importance of nourishing your microbiome with healthy foods.

According to his amazon.com bio, “David Perlmutter, MD, is a globally recognized leader in brain science. He is the recipient of the Linus Pauling Award, editor-in-chief of the global online and print peer-reviewed journal Brain and Gut, and author of the #1 New York Times bestseller Grain Brain, The Grain Brain Cookbook, Brain Maker, The Better Brain Book, Raise a Smarter Child by Kindergarten, and Power Up Your Brain. He lives and practices in Naples, Florida.”

Dr. Perlmutter understands the connections between microbiome health and brain health. He speaks out about the connections between microbiome destruction via over-use of antibiotics, and chronic illness. He has acknowledged fluoroquinolone toxicity on news-casts, and has made videos about fluoroquinolone-induced peripheral neuropathy.

His presentation was wonderful and if you get the opportunity to see him speak, I recommend that you do so.

I had the opportunity to thank Dr. Perlmutter for the work he’s done speaking out about fluoroquinolone toxicity.

I also had the opportunity to ask him, in the Q&A section in front of the whole audience, what can be done to encourage more doctors to understand that fluoroquinolone antibiotics are dangerous drugs that should not be used frivolously. He responded that speaking out was the way to bring about change, and that doctors and other people can be educated about the dangers of fluoroquinolones one person at a time.

Every time we share an article that connects microbiome destruction to chronic illness (several are linked to HERE), we encourage people to understand that microbiome health is critical for all areas of health, and that throwing a nuclear bomb into the gut with fluoroquinolones (information about the dangers of fluoroquinolones can be found HERE), can be devastating.

Dr. Perlmutter also spoke about how mitochondria are ancient bacteria, and every time we share information about how fluoroquinolones damage mitochondria, we are also increasing the chances of doctors and other people making the connections between mitochondria-damaging drugs and chronic illness.

The outreach advice I got from Dr. Perlmutter and Dr. Wahls (in Episode 14 of The Floxie Hope Podcast) was to keep screaming, keep telling people about fluoroquinolone toxicity, and one person at a time, minds will change.

For fluoroquinolone toxicity to be on the radar of someone as influential as Dr. Perlmutter is a HUGE step in the right direction for us. He reaches millions of people through his books, web site, journal, practice, and other contributions. If you get a chance to thank him for his fluoroquinolone toxicity awareness efforts, please do so. He is brilliant, thoughtful, interesting and a wonderful advocate. He has my respect and admiration.

 

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The Next Time Will be Worse: Cross-Reactivity of Fluoroquinolones

On every single warning label for each fluoroquinolone it says that if a person has experienced an adverse reaction to a quinolone, they should not be exposed to quinolones again.

The Cipro/ciprofloxacin warning label says:

“Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any of the product components.”

The Avelox/moxifloxacin warning label says:

“Contraindications: Known hypersensitivity to AVELOX or other quinolones.”

The Ciprodex ear drop warning label says:

“CIPRODEX® Otic is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication.”

Yet these warnings are disregarded regularly. I often hear from people who tell their doctor that they are allergic to Levaquin, and their doctor prescribes them Cipro. Or they tell their doctor that they are allergic to Cipro, but are still prescribed ofloxacin eye drops. There seems to be a lack of understanding of the cross-reactivity or one quinolone with all other quinolones.

The lack of knowledge and understanding is not because of lack of documentation. In an article in Current Pharmaceutical Design entitled “An Update on the Diagnosis of Allergic and Non-Allergic Drug Hypersensitivity,” it is noted that, “cross-reactivity among quinolones at both the IgE- and T-cell level is clinically well documented. Therefore, patients with hypersensitivity reactions to any quinolone should not be re-exposed to any antimicrobial agents of that class.”

Additionally, in The European Journal of Allergy and Clinical Immunology’s article, “Cross-reactivity between quinolones,” it is noted that, “We conclude that cross-reactivity between quinolone seems to be very important, and avoidance of any quinolone should be recommended to any patients who has suffered an allergic reaction to one of these drugs.”

When I told my doctors at Kaiser Permanente that I wanted fluoroquinolones to be put in my chart as a drug allergy, they couldn’t do it, because “fluoroquinolones” are a class of drugs, and they could only enter individual drugs into their system. In order to get all fluoroquinolones in my chart, I had to list every fluoroquinolone separately, because if I just said that I was allergic to Cipro, they would still give me Levaquin, or Avelox or Floxin. That’s a bit ridiculous seeing as it says ON THE WARNING LABEL that if someone has a history of hyper-sensitivity to one quinolone, they should avoid exposure to other quinolones. I’m sure that it’s easier said than done, but couldn’t there be some sort of cross-population of information that takes the “clinically well documented” cross-reactivity of quinolones into consideration? If someone has experienced a severe adverse reaction to Floxin, they shouldn’t take Levaquin—it’s not that difficult a concept. But systems are not currently in place to recognize, much less track or prevent, cross-reactivity or contraindications between drugs.

fluoroquinolone-lawsuit-banner-trulaw

If a person experiences a severe adverse reaction to a fluoroquinolone and they feel as if a bomb has gone off in their body and mind, they know that they have had an adverse reaction to a quinolone. Going through one severe adverse reaction to a quinolone is enough for most people, and they are likely to realize that they should never take a quinolone again. However, there are many people who experience mild-to-moderate adverse reactions to quinolones who don’t realize that they have had an adverse reaction in the past.

For the people reading this who may have taken a fluoroquinolone in the past but haven’t had a severe adverse reaction, I encourage you to think about your health history. After taking Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, or Floxin/ofloxacin, did you experience any of the following?

Insomnia
Anxiety
Loss of endurance
Muscle twitches
Tendon tears or ruptures
Depression
GI issues
Mild peripheral neuropathy

Those are all Warning Signs of fluoroquinolone toxicity. After the first time I took ciprofloxacin I had a twitchy eyelid and intermittent stomach cramping. I wish I had known that those symptoms were adverse reactions to the ciprofloxacin, and that I had known that I could no longer tolerate it. If I had known that I had experienced an adverse reaction to ciprofloxacin in the past, and if I had known that the warning labels say that people who have had a bad reaction shouldn’t take the drug again, I wouldn’t have taken it again and I would have avoided full-blown fluoroquinolone toxicity. There are a million “if only” scenarios around my adverse reaction to ciprofloxacin. I can’t turn back time and change anything though. I can only move forward and warn people. I hope that people heed my warning, and connect bizarre, seemingly innocuous symptoms like anxiety and sprained elbows, to the fluoroquinolone they took to treat an infection, and that they avoid future use of fluoroquinolones.

 

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Quinolone Vigilance Foundation (QVF) Update

Quinolone Vigilance Foundation (QVF) Update

I asked Rachel Brummert, President of the QVF, to update the January, 2014 post about the QVF – https://floxiehope.com/2014/01/29/the-quinolone-vigilance-foundation-qvf/.  It turns out that a lot of updating needed to be done, so I’m making the update a whole new post.  Thank you to everyone involved with the QVF for all your efforts!  

There is a non-profit, charitable foundation devoted to raising awareness about the dangers of fluoroquinolone antibiotics and fluoroquinolone toxicity, advocating for victims, educating the medical community, and to funding research on fluoroquinolone toxicity. It is called The Quinolone Vigilance Foundation (the QVF) – www.saferpills.org.

Following is some information about the QVF:

History and Purpose

The QVF is a registered 501(c)(3) non-profit foundation established in 2009 and Incorporated in 2012. Its founders sought to establish professional credibility by reviewing the existing scientific literature that addressed adverse reactions from fluoroquinolones; recruited and networked medical researchers; and stimulated new research into this poorly understood issue. The QVF branched out in 2014 to educating the medical profession.

“Our mission is four-fold: Educating the medical profession about fluoroquinolones, advocating for victims of fluoroquinolone toxicity, raising awareness in the United States and abroad, and research. Advocacy, education, and research go hand in hand and gives a complete picture of the problem. Helping victims already affected and getting ahead of it so damage doesn’t happen in the first place is something we are very passionate about and we work hard to achieve,” explains Rachel Brummert, Executive Director of the QVF.

Advocacy and Outreach

  • In the spring of 2014, the QVF began educating doctors in local practices and major medical centers.
  • QVF has held six fundraisers since 2013 to raise funding for advocacy and education, and for the University of Rochester research study.
  • QVF sells awareness merchandise:

www.cafepress.com/quinvigil

https://www.bravelets.com/bravepage/fluoroquinolone-life-qvf

http://konectidy.com/charity/quinolone-vigilance-foundation/

  • QVF is in early stages of bringing in two new research studies.
  • QVF attended two FDA Hearings
  • QVF continues to work with media outlets to warn viewers of the dangers of fluoroquinolone antibiotics. We provide information to reporters and assist in finding victims to be interviewed.
  • QVF receives many requests from doctors offices and pharmacies for brochures and awareness cards to display. We also offer free brochures to anyone who wishes to pass them out in their communities. In addition, we offer downloadable brochures on our website under the Resources tab for anyone who wishes to print them out themselves. http://www.saferpills.org/print-download/
  • Author, actor and international speaker Josh Rivedal asked QVF to participate in the i’Mpossible Project and the upcoming book The i’Mpossible Project: Volume 1 Reengaging With Life, Creating a New You due to be released on January 13, 2016 and available for pre-order on September 16, 2015. Per an agreement with the publisher, 100% of proceeds made from our contribution to the book will be donated to QVF and no person shall personally gain from the book. QVF has been approached by several media outlets to discuss the book and about the topic of fluoroquinolone toxicity. The book will be available in paperback and e-book, at major bookstores like Books A Million, Barnes & Noble and Amazon, and online as an ebook at BN.com, Kindle, iTunes, Nook, and Google Books. The i’Mpossible Project is a collection of powerful stories. The stories in this first volume are all about overcoming obstacles, reengaging with life, and creating new possibilities. Among the other authors are Academy Award Winner James Lecesne, and actress Ali Stroker of Fox’s GLEE. We are honored to participate and to bring fluoroquinolone toxicity awareness to an international audience.
  • QVF produces awareness videos which can be readily shared to spread awareness and participates in podcasts and radio shows.

Television Media stories featuring QVF volunteers

Arizonahttp://www.abc15.com/news/local-news/investigations/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label

Arizonahttp://www.azcentral.com/videos/news/local/arizona/2014/11/04/18450053/

Michiganhttp://www.wxyz.com/news/local-news/investigations/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label

Indianahttp://www.theindychannel.com/news/u-s-world/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label

Florida- http://www.wptv.com/money/consumer/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label

Ohiohttp://www.wcpo.com/news/health/healthy-living/levaquin-popular-antibiotic-carries-side-effects-not-listed-on-label

Californiahttp://www.10news.com/news/investigations/patients-experts-popular-antibiotics-could-cause-permanent-damage-11242014

Georgiahttp://www.wsbtv.com/videos/news/channel-2-investigates-complaints-about-popular/vDDZZS/

Georgiahttp://www.wsbtv.com/news/news/local/patients-suffer-devastating-side-effects-popular-a/nj4Br/

Georgiahttp://www.wsbtv.com/videos/news/another-widow-says-medication-killed-her-husband/vDD6mw/

Californiahttp://losangeles.cbslocal.com/2015/03/04/southland-firefighter-says-popular-antibiotic-stripped-him-of-his-career/

Missourihttp://www.kctv5.com/story/28170151/fda-evaluates-popular-antibiotic-that-patients-say-makes-them-sicker

Virginiahttp://wric.com/2015/04/21/8news-investigates-could-this-antibiotic-permanently-damage-your-health/

Virginiahttp://wric.com/2015/05/20/8news-investigates-doctors-left-in-dark-about-prescription-drug-dangers/

Articles featuring QVF

Care Novate: http://carenovatemag.com/personal-account-prescription-destruction-black-box-warning/

United Kingdom: http://born-in-newyork.com/ciprofloxacin-antibiotic-resistance/

Washington Post: http://www.washingtonpost.com/national/health-science/it-pays-to-read-the-warnings-when-you-open-up-a-prescription/2015/08/03/a29e11b4-d70e-11e4-b3f2-607bd612aeac_story.html?tid=hpModule_9d3add6c-8a79-11e2-98d9-3012c1cd8d1e

Tulsa World: http://www.tulsaworld.com/opinion/idelle-davidson-the-risky-business-of-taking-antibiotics/article_bcce562a-bd78-5d92-b156-6926115be61c.html

Connecticut- http://www.courant.com/consumer/hc-ls-antibiotics-drug-reaction-20150821-story.html

Italy: http://m.ilgazzettino.it/m/gazzettino/articolo/NORDEST/1270894

QVF Staff/Volunteers

The QVF is comprised of a board of directors, non-board volunteers, and ambassadors/advocates from all over the world: The United States, Canada, Ireland, the United Kingdom, Belgium, Australia, Algeria, and Italy.

The current volunteer staff positions are as follows:

Board

Rachel Brummert – Executive Director and President

Matthew Arnold – Vice President

Donna Schutz – Assistant Director and Ambassador Coordinator

Leslie Day – Corporate Secretary

Christina Manthos -Sorrell – Treasurer

Dr. Deanna Minkler – General Board Member

Dr. Joe Hudak – General Board Member

Non-board

Victoria Chiovare – Assistant Fundraising Director

Jenny Frank- Public Relations Director

All QVF positions are staffed by volunteers who generously donate their time and talents to promote the mission and values of the organization. No one within the organization receives compensation of any kind.

More information about the QVF can be found on www.saferpills.org and you can sign up for quarterly newsletters to keep up to date on QVF projects and activities.

To donate to QVF: donations@saferpills.org. All donations are tax deductible.

 

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Request a Congressional Hearing

Please join me in requesting a Congressional Hearing about the damage that fluoroquinolone antibiotics have done.  Cipro, Levaquin, Avelox, Floxin and their generic counterparts have disabled people, ruined lives and even killed people.  The cellular damage done by fluoroquinolones is unacceptable.

When car companies make faulty vehicles that kill people, there are Congressional hearings.  But when pharmaceutical companies make drugs that kill and maim people the mantra of “all drugs have side-effects” is repeated over and over again, and no rectifying action is taken.  It’s time for that to change.

The amount of damage done by fluoroquinolones is ridiculous.  Fluoroquinolones damage mitochondria, lead to massive amounts of oxidative stress, destroy the microbiome, cause neurotransmitter imbalances, etc.  Each level of damage caused by fluoroquinolones is linked to chronic diseases including autoimmune diseases, neurodegenerative diseases and the “mysterious” diseases of modernity like fibromyalgia and ME/CFS.

Instructions on how to request a Congressional Hearing can be found HERE.  (If you have any trouble opening the link, please let me know via email – floxiehope@gmail.com.)

Thank you for taking the time to email the Representatives that can get a Congressional Hearing for fluoroquinolone toxicity on the agenda!

 

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