The A to Z of Fluoroquinolone Toxicity Syndrome

The following was written by Kim Jansen. You can read Kim’s story of fluoroquinolone toxicity HERE

If you are interested in writing a guest-post for floxiehope.com, please let me know. Here is a post with more information about writing for floxiehope.

Here is a version of this post that is easier to read and print. It’s a great overview of fluoroquinolone toxicity to give to your loved-ones. The A to Z of Fluoroquinolone Toxicity Syndrome

The A to Z of Fluoroquinolone Toxicity Syndrome

A. Antibiotic. Fluoroquinolones are a family of broad-spectrum antibiotics that are commonly used to treat a variety of illnesses such as respiratory and urinary tract infections. Types of fluoroquinolones (along with their brand-names in brackets), include: ciprofloxacin (Cipro); levofloxacin (Levaquin); moxifloxacin (Avelox); gatifloxacin (Tequin); ofloxacin (Ocuflox/Floxin/Floxacin); norfloxacin (Noroxin). These antibiotics have serious side effects, with the term ‘fluoroquinolone toxicity syndrome’ being used to refer to the condition experienced by those who suffer from these side effects.

B. Bayer. Bayer is a pharmaceutical company that manufactures Cipro and Avelox. Bayer is currently facing a new lawsuit from a complainant, who has been diagnosed with peripheral neuropathy (see ‘Nerve Damage’ entry below) since 2011. She alleges that Bayer knew that Cipro could cause chronic or permanent peripheral neuropathy soon after receiving FDA (U.S) approval in 1987. By 1988, the drug companies possessed at least one published case report that constituted a safety “signal” that fluoroquinolones were associated peripheral nerve damage and that further investigation and study were necessary to protect patients. Since then, numerous other studies have affirmed this connection. This complainant’s Cipro lawsuit joins hundreds of other fluoroquinolone toxicity claims pending against manufacturers of fluoroquinolone antibiotics.

C. Central Nervous System Damage. Fluoroquinolones are able to penetrate the blood brain barrier, thus also able to damage a person’s central nervous system . The FDA in America acknowledged this fact and placed a warning about potential CNS damage on fluoroquinolone medication (see ‘FDA Warnings’ entry below). Some of the side effects of CNS damage include insomnia, restlessness, seizures, convulsions, and psychosis. An extensive collaborative investigation by scientists and member of a social network in 2016 found that 93 of 94 respondents of a survey reported fluoroquinolone-associated events including anxiety, depression, insomnia, panic attacks, clouded thinking, depersonalization, suicidal thoughts, psychosis, nightmares, and impaired memory beginning within days of fluoroquinolone initiation or days to months of fluoroquinolone discontinuation. They also discovered that mice treated with ciprofloxacin had lower grip strengths, reduced balance, and depressive behaviour compared with the controls.

D. DNA Damage. Fluoroquinolones work by inhibiting the replication of bacterial DNA. Tests have shown that these antibiotics also damage healthy DNA, including mitochondrial DNA. This is one of the likely reasons why the damage caused by fluoroquinolone toxicity affects multiple body systems and is persistent.

E. EMA. Public Hearing. In June 2018, the EMA (European Medicines Agency) held a public hearing to discuss the serious health concerns surrounding side effects of quinolones and fluoroquinolones. On 15 November 2018, EMA finalised a review of serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018. Here is an excerpt from the press release of their findings:
EMA’s human medicines committee (CHMP) endorsed the recommendations of EMA’s safety committee (PRAC) and concluded that the marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid, and pipemidic acid should be suspended. The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted. In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system.

F. FDA Warnings. The U.S. Food and Drug Administration has issued a series of warnings over the last number of years regarding serious and potentially permanent adverse side effects of fluoroquinolones, including a ‘Black Box’ warning (its strongest warning possible) in 2008, which it has upgraded numerous times since. A summary of the warnings is below:
a. 2008 – increased risk of tendinitis and tendon rupture.
b. 2011 – fluoroquinolones may have neuromuscular blocking activity.
c. 2013 – the potential for irreversible peripheral neuropathy (serious nerve damage).
d. 2016 – disabling and potentially permanent serious side effects that can occur together which may involve the tendons, muscles, joints, nerves, and central nervous system.
e. 2018 (July) – may cause significant decreases in blood sugar, potentially resulting in coma, as well as certain mental health side effects, including disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities called delirium.
f. 2018 (December) – the risk of aortic aneurysm and dissection.
Fluoroquinolones are now deemed to be a ‘drug of last resort’ in the U.S for most infections. The clinical guidelines in Australia, whilst not quite as strong, clearly indicate that fluoroquinolones should be reserved for serious bacterial infections for which an alternative treatment is not available. The reality of over-prescription and lack of physician awareness of the side effects of fluoroquinolones indicate a significant disconnect between the official regulatory bodies and current medical practice.

G. Glutathione. Glutathione is an important antioxidant. It is comprised of three amino acids (cysteine, glutamic acid, and glycine) present in most mammalian tissue. Glutathione also acts as a free radical scavenger and a detoxifying agent. A 2011 study found that the fluoroquinolone antibiotic Ciprofloxacin causes a significant decrease in glutathione levels in the body (a 25.5% decrease in levels by the fifth day of treatment.) . The reduction of glutathione in the body caused by fluoroquinolones is likely to be a contributing factor to the oxidative stress (see ‘Oxidative Stress’ entry below) caused by fluoroquinolones. Tests conducted on rats also revealed administering Ciprofloxacin resulted in a significant decrease in glutathione content in the liver.

H. Heart Damage. Due to its collagen-depleting mechanism, fluoroquinolones can cause serious damage to the heart. The U.S FDA released a warning in December 2018, stating that patients should avoid fluoroquinolone antibiotics due to an increased risk of heart-vessel tears. ‘These tears,’ it stated, ‘called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death’.

I. Income loss. One of the all-too frequent associated impacts of fluoroquinolone toxicity is the sufferer’s inability to continue in paid employment. There are many media and online stories where people share the devastating impact this drug has had, not just on their health, but on their family relationships, their livelihood and their ability to be financially independent. One such news story is footnoted here.

J. Johnson & Johnson. Johnson & Johnson’s Janssen Pharmaceuticals unit discontinued production of the fluoroquinolone antibiotic Levaquin in December 2017, amid growing concerns over the serious side effects and complications potentially associated with the use of fluoroquinolone antibiotics. Another likely reason for this discontinuation by Johnson & Johnson is due to its having lost millions of dollars in previous lawsuits over Levaquin, (including settling 845 lawsuits over Levaquin in 2012) . There are still hundreds of individuals waiting to have their cases heard over debilitating injuries caused by Levaquin and other fluoroquinolones, which is another likely reason for Johnson & Johnson’s decision. Johnson & Johnson’s decision to cease manufacturing this drug does not constitute a product recall, with the drug still being available with the J&J brand until 2020 and generic versions of the drug continuing indefinitely at this stage.

K. Kidney Damage. Fluoroquinolone antibiotics can cause kidney damage including renal failure. A 2013 study found a twofold increased risk of acute kidney injury requiring hospital admission with the use of fluoroquinolone antibiotics among adult men.

L. Levaquin. Levaquin is the brand name of a type of fluoroquinolone antibiotic manufactured by Janssen Pharmaceutical (see ‘Johnson & Johnson’ entry above). The drug’s scientific name is levofloxacin. Levaquin has been the subject of hundreds of lawsuits by patients who have suffered debilitating side effects from this drug.

M. Mitochondrial Toxicity. The mitochondria are rod-shaped organelles that are the ‘power generators’ of cells, ‘turning sugars, fats and proteins that we eat, into forms of chemical energy that the body can use to carry on living’. Fluoroquinolones damage mitochondrial DNA, resulting in a range of disabling symptoms in sufferers, including pain, weakness and fatigue.

N. Nerve Damage. Many sufferers of fluoroquinolone toxicity syndrome experience nerve damage, often resulting in peripheral neuropathy. Peripheral neuropathy is a condition in which the nerves in the peripheral nervous system become damaged. Usually the disorder affects the nerves that provide sensation, which causes pain, tingling, and burning symptoms of the nerves affected, frequently, but not limited to, the hands and feet. The U.S. Food and Drug Administration enhanced its warnings of fluoroquinolone side effects in 2013 to include ‘the potential for irreversible peripheral neuropathy’.

O. Oxidative Stress. ‘Oxidative stress occurs when excess oxygen radicals are produced in cells, which could overwhelm the normal antioxidant capacity. [Oxidative stress can lead to damage of] proteins, lipids, and DNA, which could lead to cytotoxicity, genotoxicity, and even carcinogenesis when damaged (mutated) cells can proliferate.’ A scientific study conducted in 2011 demonstrated that fluoroquinolone antibiotics are a significant cause of oxidative stress, with tests revealing this stress was ‘greatest 5 days after exposure to ciprofloxacin and levofloxacin therapy, which indicates the formation of reactive oxygen species as in previous studies with fluoroquinolones. These results [were] further supported by [a] decrease in plasma antioxidant status by 77.6% and 50.5% for ciprofloxacin and levofloxacin respectively’24. They concluded their report with the finding that ‘[t]here was a considerable increase in lipid peroxide levels indicating an enormous oxidative stress’ in patients taking fluoroquinolones and suggested that increase in oxidative stress may be responsible for the pathological mechanism of tendinitis (see ‘Tendon Ruptures’ entry below).

P. Pain. Pain is often (but not always) the first symptom fluoroquinolone toxicity sufferers experience. This can occur after the first dose taken. The pain usually begins in the legs or feet before spreading to other parts of the body. The pain will often be constant and remain for months or years. Pain in joints, hands, feet, tendons and nerves (see ‘Nerve Damage’ entry above) is common, ranging in severity from a dull ache to, extreme, sharp, unbearable pain. Many case studies document patients living with extreme, ongoing pain that cannot be medically managed.

Q. Quinolones. Quinolones are an earlier generation of the current fluoroquinolone family of antibiotics (although quinolones are still in limited use). A fluorine atom was added to the quinolone’s central ring system, thus creating fluoroquinolones, which have proven to be more effective in disrupting bacterial DNA than the quinolone form of the antibiotic.

R. Relapse. Many sufferers of fluoroquinolone toxicity syndrome report (often multiple) relapses of their symptoms, sometimes years after the initial onset of their illness. This is likely due to the multi-system, cellular and oxidative-stress nature of this toxicity. Sometimes a relapse can be caused by a specific trigger, such as the subsequent use of NSAIDs (such as ibuprofen) or steroid medications.

S. Suicide. There have been thousands of reported cases of deaths linked to fluoroquinolone toxicity (over 6500 to the end of 2015 in the U.S alone). This number, however, does not include the large number of people who have taken their own lives after experiencing sudden and extreme mental health side effects from fluoroquinolones. A group of doctors wrote an article for the European Journal of Internal Medicine in which they report on the concerning number of suicides or attempted suicides by patients on fluoroquinolone antibiotics. They cite that in the United States, 40% of reported fluoroquinolone-related suicide events occurred within two weeks of taking fluoroquinolone medication. Many of these patients had no previous mental health issues.

T. Tendon Ruptures/Tendonitis. One of the most common adverse side effects of fluoroquinolones is tendon damage, including tendon ruptures, frequently to the Achilles tendon. This is due to a combination of factors, including fluoroquinolones being responsible for destroying collagen (collagen is a major component of tendons). A study in 2015 investigated the impact of fluoroquinolones on collagen and discovered that fluoroquinolones ‘were associated with almost a tripling of the risk of tendon ruptures—a recognised collagen-associated adverse event induced by these medications.’ Perhaps of even greater concern was their finding that ‘fluoroquinolones were associated with a similar increase in the risk of aortic aneurysms.’

U. Under-reporting. It is almost certain that fluoroquinolone toxicity is under-reported. Drug safety professionals estimate that only 10% of adverse events (across all drugs) are reported to the FDA every year, in part due to physicians having no requirement or incentive to report adverse reactions. It is highly likely that the rate of adverse reaction reporting for fluoroquinolone antibiotics is lower still, for the following reasons:
a. The noticeable symptoms of fluoroquinolone toxicity can take months to manifest, thus making it more likely that the patient does not connect their ‘new’ symptoms with a course of fluoroquinolone antibiotics they took previously.
b. Many medical practitioners are still unaware of, or refuse to acknowledge, the damage that fluoroquinolone antibiotics can cause. This is evidenced in the frequency with which these antibiotics are prescribed for uncomplicated (suspected) infections when safer alternatives are available. As one report states: ‘Despite these seemingly significant numbers and overwhelming reports from patients, physicians continue to prescribe fluoroquinolone antibiotics unsystematically, against US Food and Drug Administration recommendations. Thus, adverse reactions to fluoroquinolones are often not reported by physicians, nor by the patient themselves. Even though significant under-reporting is extremely likely, there are over 200,000 reported cases of adverse reactions to fluoroquinolone antibiotics in the U.S alone, tens of thousands of these being serious and over 6,000 reported deaths. 1,498 cases of adverse reactions to Ciprofloxacin have been submitted to Australia’s Therapeutic Goods Administration (up to 18 January 2019).

V. Vitamins and Minerals. There is no quick cure or treatment for fluoroquinolone toxicity. Healing plans usually focus on rest and a diet/supplement regime which aims to replenish those essential elements that have been depleted or damaged by the drug. One of the most important mineral supplements is magnesium. This is because fluoroquinolones deplete magnesium from the body and also because toxicity from fluoroquinolones is reduced by the supplementation of magnesium (as proven through tests conducted on both humans and rats).

W. Weakness and Fatigue. Alongside pain, muscle weakness and fatigue are often the first symptoms fluoroquinolone toxicity sufferers experience. The weakness is likely a result of the cellular damage caused by the drug, including damage to the mitochondria in the cells (see ‘Mitochondrial Toxicity’ entry above). As a consequence, many sufferers are (mis)diagnosed with CFS/ME (Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis).

X. The X Factor (the unknowns). Scientists and medical professionals are still discovering all the ways in which fluoroquinolones adversely affect the body and mind. Much is still unknown about the long-term impacts of this drug. One of the more frightening discoveries in recent years is the likelihood that fluoroquinolone toxicity sufferers are at a significantly higher risk of developing Parkinson’s Disease and Alzheimer’s due to the long-term oxidative stress caused by this drug and by the damage it causes to the cells’ mitochondria (see ‘Oxidative Stress’ and ‘Mitochondrial Toxicity’ entries above). In 2014, A U.S. medical practitioner, Charles Bennett, who has conducted a great deal of research on fluoroquinolone toxicity, filed a citizen’s petition with the FDA seeking to expand the black box warning to include mitochondrial toxicity as one of its side effects, with the concern that it can lead to Parkinson’s Disease and Alzheimer’s.

Y. Years. People who suffer from fluoroquinolone toxicity often take years to recover, whilst others experience little improvement in their symptoms, even years after first suffering toxicity (as evidenced by some of the speakers at the EMA public hearing in June 2018).

Z. ZZZZ (sleep). The European Medicines Agency’s 2018 public hearing and investigation into fluoroquinolones concluded that sleep problems (including nightmares and insomnia) were among the many long-term side effects of fluoroquinolone toxicity. Sadly, much of the medical profession world-wide seems to have no trouble being asleep to the dangers of fluoroquinolones, with doctors continuing to prescribe this drug in the millions each year for uncomplicated health conditions where safer, as effective antibiotics are available. Patients also continue to report having been prescribed fluoroquinolones without being given any information about the risk of serious, potentially permanent, side effects.

References:

  1. The Marshall Protocol Knowledge Base. “Fluoroquinolone Antibiotics”: https://mpkb.org/home/othertreatments/antibacterials/fluoroquinolones
  2. Arentz Law Group. “Cipro Lawsuit Alleges Bayer Actively Concealed Irreversible Peripheral Neuropathy Risks.” https://arentzlaw.com/defective-drug/cipro-lawsuit-peripheral-neuropathy/
  3. Dr Joseph Mercola. “Antibiotic Alert: The Drug the Doctor Ordered Could Cause Deadly Side Effects.”
    https://articles.mercola.com/sites/articles/archive/2012/10/20/fluoroquinolones-side-effects.aspx
  4. Oncology Practice. “Fluoroquinolone-related neuropsychiatric and mitochondrial toxicity: a collaborative investigation by scientists and members of a social network.” https://www.ncbi.nlm.nih.gov/pubmed/26955658
  5. Nucleic Acids Research. “Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase-2.” https://academic.oup.com/nar/article/46/18/9625/5088042
  6. European Medicines Agency. “Quinolone- and fluoroquinolone-containing medicinal products – European Commission Final Decision.” https://www.ema.europa.eu/en/medicines/human/referrals/
    quinolone-fluoroquinolone-containing-medicinal-products
  7. FDA Drug Safety Communication. “FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects.” https://www.fda.gov/drugs/drugsafety/ucm511530.htm
  8. U.S. Food and Drug Administration. “FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections”. https://www.fda.gov/Drugs/DrugSafety/ucm500143.htm
  9. U.S National Library of Medicine. “Glutathione.” https://pubchem.ncbi.nlm.nih.gov/compound/glutathione
  10. Journal of Young Pharmacists. “Oxidative Stress Induced by Fluoroquinolones on Treatment for Complicated Urinary Tract Infections in Indian Patients.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3249743/
  11. Drug and Chemical Toxicology. “Ciprofloxacin‐Induced Glutathione Redox Status Alterations in Rat Tissues.” https://www.tandfonline.com/doi/abs/10.1081/DCT-120037504?journalCode=idct20
  12. Medical Xpress. “Certain antibiotics tied to deadly heart vessel tears: FDA.”
    https://medicalxpress.com/news/2018-12-antibiotics-tied-deadly-heart-vessel.html
  13. Al Jazeera. “Left paralysed from Fluoroquinolone antibiotic toxicity.”
    https://www.aljazeera.com/indepth/features/2017/09/left-paralysed-fluoroquinolone-antibiotic-toxicity-170919135407632.html
  14. RX Injury Help. “Janssen Discontinued Levaquin Production as Concerns Over Fluoroquinolone Side Effects Grow.” https://www.rxinjuryhelp.com/news/2018/07/18/janssen-discontinued-levaquin-production-as-concerns-over-fluoroquinolone-side-effects-grew/
  15. Drug Injury Law: Medical and Legal Information. “Johnson & Johnson settles 845 Levaquin Lawsuits.” https://www.drug-injury.com/drug_injury/2012/11/johnson-johnson-settles-845-levaquin-lawsuits.html
  16. Arentz Law Group. “Levaquin pulled from market to avoid lawsuit.”
    https://arentzlaw.com/defective-drug/jj-stops-levaquin-sales/
  17. Canadian Medical Association Journal. “Risk of acute kidney injury associated with the use of fluoroquinolones.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3708027/
  18. Thomas J Henry Law. “Johnson & Johnson Settles Levaquin Lawsuits”. https://thomasjhenrylaw.com/blog/dangerous-drugs-devices/johnson-johnson-settles-levaquin-lawsuits/
  19. Mitochondrial Biology Unit. http://www.mrc-mbu.cam.ac.uk/what-are-mitochondria
  20. Oncology Practice. “Fluoroquinolone-related neuropsychiatric and mitochondrial toxicity: a collaborative investigation by scientists and members of a social network.” https://www.mdedge.com/hematology-oncology/article/106661/patient-survivor-care/fluoroquinolone-related-neuropsychiatric
  21. Journal of Investigative Medicines: “Permanent Peripheral Neuropathy: A Case Report on a Rare but Serious Debilitating Side-Effect of Fluoroquinolone Administration.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4528905/
  22. Medicine Net. “Peripheral Neuropathy Causes, Symptoms, and Treatment Medications.” https://www.medicinenet.com/peripheral_neuropathy/article.htm#peripheral_neuropathy_definition_and_facts
  23. Science Direct. “Oxidative Stress.” https://www.sciencedirect.com/topics/neuroscience/oxidative-stress
  24. Journal of Young Pharmacists: “Oxidative Stress Induced by Fluoroquinolones on Treatment for Complicated Urinary Tract Infections in Indian Patients.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3249743/
  25. Journal of Pain & Palliative Care Pharmacotherapy. “Intractable Acute Pain Related to Fluoroquinolone-Induced Peripheral Neuropathy.” https://www.ncbi.nlm.nih.gov/pubmed/28358229
  26. US National Library of Medicine. “Fluoroquinolone-induced serious, persistent, multisymptom adverse effects.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4600819/
  27. US National Library of Medicine. “Fluoroquinolones interactions with nonsteroidal anti-inflammatory drugs.” https://www.ncbi.nlm.nih.gov/pubmed/15176310
  28. European Medicines Agency. “EMA public hearing on quinolones and fluoroquinolones.” https://www.ema.europa.eu/en/documents/other/public-hearing-quinolone-fluoroquinolone-written-interventions_en.pdf
  29. Nature. “When antibiotics turn toxic.” https://www.nature.com/articles/d41586-018-03267-5
  30. European Journal of Internal Medicine. “Fluoroquinolone-associated suicide.” https://www.ejinme.com/article/S0953-6205(18)30284-X/fulltext
  31. The Journal of Clinical and Aesthetic Dermatology. “The Risk of Fluoroquinolone-induced Tendinopathy and Tendon Rupture.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2921747/
  32. BMJ Journals. “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study.” https://bmjopen.bmj.com/content/5/11/e010077
  33. PSQH: Patient Safety and Quality Healthcare. “A Closer Look at FDA’s Adverse Event Reporting System.” https://www.psqh.com/analysis/a-closer-look-at-fdas-adverse-event-reporting-system/
  34. Oxidative Medicine and Cellular Longevity. “Treatment of the Fluoroquinolone-Associated Disability: The Pathobiochemical Implications.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5632915/
  35. Journal of Investigative Medicine. “Permanent Peripheral Neuropathy: A Case Report on a Rare but Serious Debilitating Side-Effect of Fluoroquinolone Administration.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4528905/
  36. Therapeutic Goods Administration (Australia) Database of Adverse Event Notifications – medicines https://apps.tga.gov.au/PROD/DAEN/daen-report.aspx
  37. American Society for Microbiology. “Diminished Ciprofloxacin-Induced Chondrotoxicity by Supplementation with Magnesium and Vitamin E in Immature Rats.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1803142/
  38. ME Association UK. “Update: MHRA issues new restrictions and precautions for Fluoroquinolone antibiotics 29 March.” https://www.meassociation.org.uk/2019/03/update-mhra-restrictions-and-precautions-for-fluoroquinolone-antibiotics-28-march-2019/
  39. CBS Chicago. “Safety Advocate: Powerful Antibiotics Being Overprescribed.”
    https://chicago.cbslocal.com/2015/03/11/safety-advocate-powerful-antibiotics-being-overprescribed/
  40. European Medicines Agency. “Public Hearing on quinolone and fluoroquinolone antibiotics” .
    https://www.youtube.com/watch?v=1vao8o5NGUc
  41. European Medicines Agency. “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics.” https://www.ema.europa.eu/en/news/disabling-potentially-permanent-side-effects-lead-suspension-restrictions-quinolone-fluoroquinolone

******

The Tragic Loss of Rachel Held Evans

Christian author Rachel Held Evans in 2018. (Dan Evans)

Many people in the “floxie” community have been sharing the tragic news of the death of Rachel Held Evans.

Rachel Held Evans was a popular Christian author, blogger, and speaker. She lived a significant and impactful life in the 37 years that she was alive. She was a wife to Dan Evans, and the mother of two children. Dan said of Rachel:

“She put others before herself,” her husband, Dan Evans, said in an email on Saturday. “She shared her platform. She always remembered how others had helped her. She enjoyed seeing other people in contexts where they thrived. She didn’t hold grudges, would forget as well as forgive. She had little time for pettiness and a big heart for people. And these are all things I wish I had told her more while I still had the privilege to keep her company.” (source)

There are lovely obituaries and tributes to Rachel Held Evans in many publications. Here are a couple:

Rachel Held Evans experienced an adverse reaction to an antibiotic before her death, and that adverse reaction, along with UTI and flu symptoms, are what led her to check into the hospital on April 14, 2019. On May 4, 2019, she had passed after experiencing brain-swelling, seizures, and a medically-induced coma.

Many people have asked if the antibiotic that Rachel Held Evans had a “severe allergic reaction” to was a fluoroquinolone. It is reasonable to think that the antibiotic she reacted to may have been a fluoroquinolone – fluoroquinolones are often used to treat UTIs. However, I have not seen any confirmation that Held Evans was given a fluoroquinolone. It’s possible that she was “floxed,” but it’s also possible that she reacted horribly to another antibiotic. We don’t know at this time. Perhaps her family will update her story with information about what antibiotic she reacted badly to at some time in the future. At this point, the health updates from Dan Evans don’t give specific information about the antibiotic that contributed to her illness.

What is known about Held Evans’ illness and death is summarized well in the Washington Post article, “What we know about the death of popular Christian writer Rachel Held Evans.”

We don’t know what caused her health to decline so rapidly, or what kind of antibiotic she reacted badly to. We don’t know what caused her seizures, or what happened in the hospital. We don’t know what genetic (or other) predispositions she had toward adverse drug reactions, seizures, or anything else. We don’t really know why a 37 year old woman who was healthy less than a month ago is now dead.

We do know that when she entered the hospital she was well enough to tweet and to express concern about missing the newest episode of Game of Thrones (GOT), and that while in the hospital she started to experience seizures and brain swelling. We know that the seizures and brain-swelling led to her death.

We also know that fluoroquinolones can trigger seizures. Per the FDA warning label for CIPRO:

“CIPRO, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold. As with all fluoroquinolones, use CIPRO with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (for example, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (for example, certain drug therapy, renal dysfunction). Use CIPRO when the benefits of treatment exceed the risks, since these patients are endangered because of possible undesirable CNS side effects. Cases of status epilepticus have been reported. If seizures occur, discontinue CIPRO.” (source)

But, again, we don’t know whether Rachel Held Evans took Cipro, or any other fluoroquinolone antibiotics. And we certainly don’t know whether or not fluoroquinolones caused her seizures.

We do know that the death of Rachel Held Evans is tragic, and that she will be missed by thousands (possibly millions) of people whose lives she touched. Hearts around the world are aching for her husband, children, and all others who loved her.

Considering her decline while in the hospital, I think it’s also reasonable to assume that her death was iatrogenic (caused by a medication or medical treatment). If this assumption, and questions around it, give the loved-ones of Rachel Held Evans some peace and closure, I hope that they get both answers and some form of justice.

It is clear that Rachel Held Evans was an amazing person who lived a generous, thoughtful, connected, beautiful life. It is a heartbreaking shame that she died so young and under such shocking and difficult circumstances.

My sincere condolences to her family and loved-ones.

*****

 

Ciprofloxacin Depletes Exosomal DNA

Journal of Extracellular Vesicles, “Biological properties of extracellular vesicles and their physiological functions”

The study, “Antibiotic-induced release of small extracellular vesicles (exosomes) with surface-associated DNA” published in Nature, found that, “ciprofloxacin induced the release of both DNA (mitochondrial and chromosomal sequences) and DNA-binding proteins on the exofacial surfaces of small extracellular vesicles referred to in this paper as exosomes.” And, “Our results reveal for the first time that prolonged low-dose ciprofloxacin exposure leads to the release of DNA associated with the external surface of exosomes.”

In the discussion section of “Antibiotic-induced release of small extracellular vesicles (exosomes) with surface-associated DNA” the authors expand on their findings:

“Exposure of Jurkat cells to ciprofloxacin has been shown to induce oxidative stress, production of reactive oxygen species, mitochondrial dysfunction, inhibition of the respiratory chain and decrease of mitochondrial membrane potential leading to mitophagy47. Our MS analysis has also confirmed the above biological processes in Jurkat cells. Importantly, the presence of ciprofloxacin has been reported to lead to the loss of mtDNA28, 29 and an aneuploidy caused by the genotoxic stress of Jurkat cells30, 48. Genotoxic stress response has been shown to induce the release of nucleosomes by leukemic myeloid cells49. In the present study, mitochondrial damage of ciprofloxacin-exposed Jurkat cells has been evidenced by the abundance of mtDNA, and the nucleoid protein FEN1, as well as numerous other mitochondrial proteins in the secreted vesicles. Ciprofloxacin inhibits both the bacterial DNA gyrase and the mammalian topoisomerase II enzymes responsible for proper DNA replication50. Given that ciprofloxacin mainly inhibits the mitochondrial isoform of mammalian topoisomerase II29, its presence induces mtDNA fragmentation as well as subsequent gradual decrease in mtDNA content29.”

And also note that:

“We found that the exosomal DNA release-inducing effect was not solely observed in the case of Jurkat cells as we also detected ciprofloxacin-induced release of exofacial EV DNA in the case of the pancreatic cancer cell line MiaPaCa. These results demonstrate that DNA-associated EVs may be released from various types of cells after long-term ciprofloxacin exposure.”

These findings are interesting, and I think consequential and explanatory.

But, I am guessing that most people reading this need some more information about what the excerpts above mean. I know I did (and I had to read it about five times).

First, understanding “Antibiotic-induced release of small extracellular vesicles (exosomes) with surface-associated DNA” requires a little knowledge of what extracellular vesicles and exosomes are.

Extracellular vesicles (EVs) are “lipid bilayer-delimited particles that are naturally released from a cell and, unlike a cell, cannot replicate. EVs range in diameter from near the size of the smallest physically possible unilamellar liposome (around 20-30 nanometers) to as large as 10 microns or more, although the vast majority of EVs are smaller than 200 nm. They carry a cargo of proteins, nucleic acids, lipids, metabolites, and even organelles from the parent cell. Most cells that have been studied to date are thought to release EVs, including some bacterial, fungal, and plant cells that are surrounded by cell walls. A wide variety of EV subtypes have been proposed, defined variously by size, biogenesis pathway, cargo, cellular source, and function, leading to a historically heterogenous nomenclature including terms like exosomes and ectosomes.” (Source)

Exosomes are a subtype of extracellular vesicles. “Exosomes are best defined as extracellular vesicles that are released from cells upon fusion of an intermediate endocytic compartment, the multivesicular body (MVB), with the plasma membrane.” (Source) More information (that’s only basic if you have a heavy science background) about exosomes can be found in “Q&A: What are exosomes, exactly?

Basically, they’re molecules secreted from cells that affect other cells (sometimes positively, sometimes negatively).

Here’s a series of videos that give a really high-level, shiny and high-production-value explanation of exosomes and extracellular vesicles:

Additionally, here are some interesting tidbits about extracellular vesicles (EVs) and exosomes gathered from various articles:

“In the past decade, extracellular vesicles (EVs) have been recognized as potent vehicles of intercellular communication, both in prokaryotes and eukaryotes. This is due to their capacity to transfer proteins, lipids and nucleic acids, thereby influencing various physiological and pathological functions of both recipient and parent cells. While intensive investigation has targeted the role of EVs in different pathological processes, for example, in cancer and autoimmune diseases, the EV-mediated maintenance of homeostasis and the regulation of physiological functions have remained less explored.” (Source)

“EVs alone regulated the expression of numerous genes related to inflammation and signaling.” (Source)

“EVs are carriers of pathogen-associated and damage-associated molecular patterns, cytokines, autoantigens and tissue-degrading enzymes. In addition to a possible role in the pathogenesis of a number of inflammatory conditions, such as infections and autoimmune diseases, EVs, including microvesicles (also known as microparticles), exosomes and apoptotic vesicles, have therapeutic potential and might be used as biomarkers for inflammatory diseases.” (Source)

“another significant role of EVs has emerged in the removal of unwanted molecular material as a means for cell maintenance.” (Source)

“This report is the first show that numbers of blood-derived EVs are elevated in patients suffering from CFS/ME, indicating their potential involvement in disease pathogenesis. This promising finding may not only provide insights into the mechanisms involved in the disease but also shows that EVs may be useful for early diagnosis of illness. Moreover, isolation of circulating EVs coupled to our prototype for their detection by LFIA may constitute a powerful diagnostic tool, which can be performed in a single step and in minutes. We concluded that EVs may play a critical role in CFS/ME. Studies with larger sample size, outcome measures and different study designs (i.e. cross-sectional vs. longitudinal cohorts) are now urgently needed. These studies should stratify subgroups according to illness onset and progression, and assess patients at baseline and following induction of post-exertional malaise (PEM), using the 2-day cardiopulmonary exercise test (CPET).” (Source)

“Mast cells, being capable of both degranulation and subsequent recovery, have recently attracted substantial attention as also being rich sources of secreted extracellular vesicles (including exosomes and microvesicles).” (Source)

Both extracellular vesicles and exosomes contribute to processes that are related to many illnesses (including multi-symptom chronic illnesses like ME/CFS and autoimmune diseases, as well as cancer), as well as some of the processes behind those diseases such as inflammation, mast cell activation, cellular signaling and communication, etc. Neither extracellular vessicles nor exosomes are bad though – they are neither good nor bad. They are a natural function, and their relationship to these disease processes may be to spread the disease or prevent the disease, depending on many more factors than I can even begin to fathom.

I surmise and assume though, that removal and depletion of DNA from exosomes, is not a healthy or productive thing to do. And as this study showed, ciprofloxacin, and probably other fluoroquinolones, remove/deplete DNA from exosomes.

Can the removal of DNA from exosomes trigger inflammation? Can the depletion of DNA from exosomes change the inter-cellular communication in ways that trigger illnesses? Extracellular vesicles and exosomes are involved with the immune system, so can depletion of DNA from exosomes trigger immune dysregulation or autoimmune diseases? In depleting DNA from exosomes, does ciprofloxacin trigger disease? We know that ciprofloxacin can trigger multi-symptom chronic illness – is the depletion of exosomal DNA the mechanism through which it “floxes” people?

I don’t know the answers to those questions, and I doubt that the scientists who know much more about cellular processes than I do know those answers either. But “Antibiotic-induced release of small extracellular vesicles (exosomes) with surface-associated DNA” raises some really interesting questions, and provides some interesting and insightful links for those of us who are exploring what occurs in the body of a “floxed” person.

Sources*:

Nature, “Antibiotic-induced release of small extracellular vesicles (exosomes) with surface-associated DNA

BMC Biology, “Q&A: What are exosomes, exactly?

Journal of Extracellular Vesicles, “Biological properties of extracellular vesicles and their physiological functions

Cellular and Molecular Life Sciences, “Critical role of extracellular vesicles in modulating the cellular effects of cytokines.

Nature Reviews. Rheumatology., “Emerging role of extracellular vesicles in inflammatory diseases.

Journal of Extracellular Vesicles, “Circulating extracellular vesicles as potential biomarkers in chronic fatigue syndrome/myalgic encephalomyelitis: an exploratory pilot study

Seminars in Cell and Developmental Biology, “Mast cell secretome: Soluble and vesicular components.

*I found these sources through the post “Nature’s Quinolones: The 4Qs” on FluoroquinoloneThyroid.com – you should check it out – it’s great.

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EMA Final Decision re Fluoroquinolones

The European Medicines Agency (EMA) released their final decision regarding fluoroquinolones. You can read the EMA verdict in “Quinolone- and fluoroquinolone-containing medicinal products” and “Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics” (both from the EMA web site). Additional information can be found on the UK Government web site in the article, “Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects.” Changes to European fluoroquinolone labels can be viewed HERE.

From the EMA:

Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used:

  • to treat infections that might get better without treatment or are not severe (such as throat infections);
  • to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
  • for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
  • to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.

Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used with special caution in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided.

Please excuse me for not knowing exactly how European drug regulation works (and please correct me if I am wrong), but it looks like the EMA makes recommendations, then the various European governments pass down instructions to their citizens.

The UK government web site gave the following recommendations to healthcare providers:

Advice for healthcare professionals:

  • systemic (by mouth, injection, or inhalation) fluoroquinolones can very rarely cause long-lasting (up to months or years), disabling, and potentially irreversible side effects, sometimes affecting multiple systems, organ classes, and senses
  • advise patients to stop treatment at the first signs of a serious adverse reaction, such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects, and to contact their doctor immediately for further advice – sheet for patients

do not prescribe fluoroquinolones:

  • for non-severe or self-limiting infections, or non-bacterial conditions

  • for some mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease; please refer to revised indications in the Summary of Product Characteristics) unless other antibiotics that are commonly recommended for these infections are considered inappropriate (see below)

  • ciprofloxacin or levofloxacin should no longer be prescribed for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate (see below)avoid use in patients who have previously had serious adverse reactions with a quinolone or fluoroquinolone antibiotic

  • prescribe with special caution for people older than 60 years and for those with renal impairment or solid-organ transplants because they are at a higher risk of tendon injury avoid use of a corticosteroid with a fluoroquinolone since co-administration could exacerbate fluoroquinolone-induced tendinitis and tendon rupture

  • report suspected adverse drug reactions to fluoroquinolone antibiotics on the Yellow Card website or via the Yellow Card app (download it from the Apple App Store, or Google Play Store)

I hate that they put “very rarely” into these warnings, seeing as adverse reactions to fluoroquinolones are woefully under-studied and the assertion that these effects are “rare” is based on assumption rather than fact. BUT, these prescriber guidelines, along with the EMA guidelines, are steps in the right direction, and hopefully they will cut unnecessary fluoroquinolone prescriptions significantly.

Here are a few notes about the proposed changes to the European Fluoroquinolone Warning Labels:

  1. It is recommended that fluoroquinolone use be restricted for uncomplicated cystitis, Acute exacerbation of chronic bronchitis and of chronic obstructive pulmonary disease, Acute bacterial rhinosinusitis, and Otitis media acute.
  2. The warning labels are still leaving a lot of discretion to doctors/prescribers, and state, “In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.” even though other parts of the warning label note that FQs should not be used for that particular indication. I worry that this may lead to some confusion among doctors/prescribers.
  3. The new warning label notes that people who have experienced adverse reactions to fluoroquinolones in the past should not take fluoroquinolones. “The use of [INN] should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment of these patients with [INN] should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment.”
  4. The possibility of prolonged, serious, and disabling side effects of fluoroquinolones are noted. “Prolonged, disabling and potentially irreversible serious adverse drug reactions
    Very rare cases of prolonged (continuing months or years), disabling and potentially
    irreversible serious adverse drug reactions affecting different, sometimes multiple, body
    systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients
    receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk
    factors. [INN] should be discontinued immediately at the first signs or symptoms of any
    serious adverse reaction and patients should be advised to contact their prescriber for
    advice.”
  5. I’m slightly shocked that the risk of tendon problems is just-now being added to European warning labels, but it is one of the changes noted. “Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided. At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with [INN] should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.”
  6. Warnings about peripheral neuropathy are also added. “Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under treatment with [INN] should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition.”
  7. Permanently disabling effects are noted again, “*Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors.”
  8. Disappointingly, the “Package leaflet: Information for the patient” is full of the words “very rarely” when referring to all the potential effects of fluoroquinolones. Again, the exact rate of adverse reactions to fluoroquinolones is unknown (and may be unknowable because of delayed adverse reactions), and I think that it’s a dis-service to patients to downplay the possibility of these serious and severe effects of fluoroquinolones.

THANK YOU, THANK YOU, THANK YOU to all the European advocates that pushed for these changes in fluoroquinolone warnings and prescribing. You have made an enormous difference, and hopefully rates of fluoroquinolone prescriptions will decrease significantly because of your advocacy.

*****

Levofloxacin and Azithromycin Both Cause Heart Rhythm Abnormalities

The CBS News article, “FDA warns azithromycin “Z-pack” antibiotics could lead to deadly heart rhythms for some” has been circulating around Facebook lately. The article is from 2013, but it is still relevant today, and I am glad to see that people are spreading the word about the dangers and consequences of all antibiotics.

However, whenever I see the article posted, I want to scream – Levaquin/levofloxacin is just as bad, if not worse, for heart health, than azithromycin/Z-packs. 

The article in Annals of Family Medicine, “Azithromycin and Levofloxacin Use and Increased Risk of Cardiac Arrhythmia and Death” concluded that:

“Compared with amoxicillin, azithromycin resulted in a statistically significant increase in mortality and arrhythmia risks on days 1 to 5, but not 6 to 10. Levofloxacin, which was predominantly dispensed for a minimum of 10 days, resulted in an increased risk throughout the 10-day period.”

The article elaborates:

“In this nationwide cohort study of US veterans, compared with amoxicillin, we found that a short-course of azithromycin therapy was associated with statistically significant hazard ratios of 1.47 for mortality risks and 1.77 serious arrhythmias risks within the first 5 days of treatment. The risk of these events was not significantly increased for days 6 to 10. Treatment with levofloxacin, also when compared with amoxicillin, had statistically significant hazard ratios of 2.49 for mortality risk and 2.43 for serious arrhythmia risk; however, the increased risk with levofloxacin continued to be statistically significant during days 6 to 10.”

Both azithromycin/Z-packs and Levofloxacin are more dangerous than amoxicillin. But Levofloxacin is more dangerous to the heart for a longer period of time.

The warning label for fluoroquinolones elaborate on the arrhythmia risk:

“Some fluoroquinolones, including LEVAQUIN®, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Rare cases of torsade de pointes have been spontaneously reported during postmarketing surveillance in patients receiving fluoroquinolones, including LEVAQUIN® . LEVAQUIN® should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.”

Additionally, fluoroquinolones increase the risk of aortic ruptures and tears. The FDA added warnings about aortic tears and ruptures to fluoroquinolone warning labels in 2018 – “FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients.”

People should be aware of the increased risk of heart rhythm irregularities with azithromycin/Z-packs. They should know that azithromycin prescriptions can have deadly consequences. People should also know that fluoroquinolones, Levofloxacin in particular, is NOT a safer alternative. In fact, it’s even more dangerous than azithromycin, and it not only causes deadly heart-rhythm irregularities, it also damages blood vessels.

People with pre-existing heart-rhythm irregularities should avoid both azithromycin and levofloxacin (as well as the other fluoroquinolones).

Doctors and patients alike should be aware of these risks to heart and vascular health that are associated with antibiotic use. A decade ago it would have been considered unthinkable that antibiotics could be linked to heart and vascular problems. But the research has shown that these connections exist.

Be careful, my friends. And spread the word about all dangerous antibiotics.

*****

Floxie Hope Podcast Episodes 27 & 28 – Dawn

Dawn shares her journey through fluoroquinolone toxicity on episodes 27 and 28 of The Floxie Hope Podcast. Please listen to, and share, these podcasts:

http://www.floxiehopepodcast.com/episode-027-dawn/

http://www.floxiehopepodcast.com/episode-028-dawn-2/

Both podcasts can be downloaded through iTunes as well: https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

Dawn suffered from severe depression, suicidal ideation, and dark thoughts that made her fear for her life. I hope that her story helps others who are going through this to know that they are not alone.

A couple of compounding issues that Dawn had were benzodiazepine withdrawal and breast implant illness. If anyone is suffering from those issues too, Dawn’s story will likely resonate with them too.

Please accept my apologies for both splitting Dawn’s story into two podcast episodes, and for the poor sound quality. My computer that I knew how to produce podcasts on died, and I’m having some issues with my new computer. Thank you for your patience, and for listening to Dawn’s episodes of the podcast despite the poor production quality.

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Fluoroquinolone Toxicity News in South Africa – Carte Blanche

I encourage you all to watch, and share, the WONDERFUL news story from Carte Blanche, a South African investigative journalism television series, about the dangers of fluoroquinolones. It’s one of the best pieces of journalism I have seen regarding fluoroquinolone adverse-effects. You can view the story through the Carte Blanche web site, or through Youtube:

Carte Blanche Web Site, “Antibiotic Alert”

Video Link

Carte Blanche tells the stories of pain brought on by fluoroquinolones for three South African “floxies,” Tracy Witelson, Gerald Ludwinsky, and Debbi Kinrade. Their stories are powerful and poignant, and they thoroughly describe the horror of fluoroquinolone toxicity.

The Carte Blanche journalist that interviews the victims of fluoroquinolones, as well as Bayer representatives and representatives of the South African Health Products Regulatory Authority (SAHPRA), does a WONDERFUL job of compassionately framing the stories of the victims, and pushing the pharmaceutical and SAHPRA representatives by asking them tough questions, challenging them, and doing what he can to hold them accountable for the harm done by fluoroquinolones.

In an exchange that is simply wonderful, journalist Derek Watts goes over the newly (2016-2018) highlighted warnings included on the FDA warning labels for fluoroquinolones (including a warning that notes that fluoroquinolones can cause permanent disability, one that notes that the risks of fluoroquinolone use outweigh the benefits, one that notes that fluoroquinolones cause blood-sugar irregularities and mental health adverse-effects, and one that notes that fluoroquinolones increase the risk of aortic aneurysm and dissection) with Dr. Naren Jairam, the Bayer Pharmaceuticals representative. Dr. Jairam dismissively asserts that these warnings are nothing new. Watts responds by asking Jairam why Bayer hasn’t been communicating the dangers of fluoroquinolones with doctors (much less patients). Jairam claims that Bayer supports responsible use of antibiotics and that Bayer has advocated that fluoroquinolones not be used as first-line antibiotics. Watts CALLS HIM OUT and says, “That’s not true,” and notes that millions of prescriptions for non-life-threatening infections are being given all over the world. It is truly wonderful to see a quick-witted journalist asking tough questions of pharmaceutical company representatives, and calling them out when they lie and mislead.

In another exchange, Watts asks Jairam, “Is your intention to obfuscate or clarify?” VERY good question – thank you for having the chutzpah to ask, Mr. Watts!

Watts also confronts Eric Chauke, Bayer’s Head of Regulatory Affairs, by asking him to show that Bayer is communicating the risk of harm by fluoroquinolones with doctors. Chauke shows Watts some general pamphlets on antibiotic stewardship, and Watts pushes back – noting that there is nothing in what Chauke is showing him that adequately communicates that fluoroquinolones can have “dreadful side-effects” or that adequately communicates that fluoroquinolones should not be used as first-line antibiotics.

Watts also asks Professor Marc Blockman, a representative of the South African Health Products Regulatory Authority (SAHPRA), some tough questions. He asks whether or not the SAHPRA warnings are adequate, and why SAHPRA can’t send a communication to doctors stating, “don’t prescribe these drugs unless it’s life threatening and there is no alternative?” Patient advocates have been asking the same thing for years, and it’s nice to hear a journalist ask this question to a drug regulator.

I love how tough Watts is on the Bayer and SAHPRA representatives. He is doing a wonderful job at being a journalist that brings to light stories of victims, and holding those in-power responsible for their role in victimizing people.

Please watch and share the Carte Blanche piece on fluoroquinolones. It’s wonderful, and it would be great for it to be internationally “viral.”

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