The U.S. Food and Drug Administration today is requiring safety labeling changes for a class of antibiotics called fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances, and make these warnings more consistent across the labeling for all fluoroquinolones taken by mouth or given by injection.
“The use of fluoroquinolones has a place in the treatment of serious bacterial infections — such as certain types of bacterial pneumonia — where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option. The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health careproviders and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive) and delafloxacin (Baxdela). There are more than 60 generic versions. The safety labeling changes the FDA is requiring today were based on a comprehensive review of the FDA’s adverse event reports and case reports published in medical literature.
Across the fluoroquinolone antibiotic class, a range of mental health side effects are already described in the Warnings and Precautions section of the drug labeling, but differed by individual drug. The new class-wide labeling changes will require that the mental health side effects be listed separately from other central nervous system side effects and be consistent across the labeling of the fluoroquinolone class. The mental health side effects to be included in the labeling across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.
Additionally, the recent FDA review found instances of hypoglycemic coma where users of fluoroquinolones experienced hypoglycemia. As a result, the Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones will now be required to explicitly reflect the potential risk of coma with hypoglycemia.
Today, the FDA also published a drug safety communication about safety information regarding hypoglycemic coma and mental health side effects with fluoroquinolones.
The FDA first added a Boxed Warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture. In February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning. In August 2013, the agency required updates to the labeling to describe the potential for irreversible peripheral neuropathy (serious nerve damage).
In 2016, the FDA enhanced warnings about the association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system. Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options.
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.
This is an important announcement and another small step in the right direction towards limiting the use of these incredibly dangerous drugs. Everyone in the medical community is so worried about antibiotic resistance and yet no one is really paying attention to the incredibly common occurrence of severe adverse drug reactions (ADRs) to fluoroquinolones (FQs). The sad and sorry truth is that there are literally millions upon millions of people in the US who have been seriously harmed by FQs, but unfortunately, most have delayed reactions so neither they nor their medical teams have made the connection. This is why ADRs to FQs are under reported by a factor of a hundred or more, even more so than with most drugs. Doctors routinely misdiagnose victims with fibro, lupus, ALS, Parkinson’s, MS, various autoimmune disorders and a hundred or more other WRONG conditions. Worse yet, they then insist we take more of their toxic and often addictive drugs even when we do not show indicators that we actually have these conditions. These unneeded drugs inevitably make our conditions worse rather than better and often leave us struggling through horrible withdrawals which make a terrible situation even worse.
It is hard to describe and impossible to exaggerate just how HORRIFIC it is to have a toxic chemical melting your connective tissue and disrupting collagen production from head to toe. I am so glad that FDA finally acknowledged the terrifying mental issues we so often endure, but it is much too little, much too late. This is a global catastrophe of almost unimaginable scope and scale that will take trillions of dollars to clean up after. This is the thalidomide story of our generation, times a hundred, and it will be in the news a lot for the next decade or two. There will need to be massive government and NPO actions to deal with this crisis, as every single community and almost every family has been affected. Someone you love is “floxed”, the slang term for our condition, a condition that is often permanent, by the way. The articles about this announcement often read that these mental problems can occur “while taking the drugs”, which falsely implies that the problems will go away once we discontinue them. THAT NEVER HAPPENS! These are not side effects, they are direct damage to our bodies, and in particular to our DNA, so that we continue reproducing defective cellular matrices long into the future, perhaps until death. Of course, for many, death comes almost immediately, in which case the doctor will of course attribute it to the disease or condition they suspected and not the drug or combination of drugs they were poisoned with. One study I read showed FQs are used inappropriately 87 out of 88 times, with most patients not needing an antibiotic at all or needing a much less potent antibiotic in the first place. Of the small percentage that actually needed an FQ, the vast majority were either prescribed too much each day or they were prescribed for too long or the patients were prescribed other drugs that are contraindicated concurrently. Only 1 out of 88 times did the doctors give the patient the right drug in the right way. This is a big part of why we have a pandemic of floxed people, although FQs are so toxic that some people die on their first or second dose.
Did you know that most other drugs in the class are used for chemo treatments? I was given chemo with no warning or consultation, and on a whim my idiot doctor decided to double the dose and triple the duration. He also had me on several drugs that are contraindicated and then, as more and more obvious symptoms of an FQ ADR were setting in, they failed to spot the fat loud stinking elephant in the room and continued to add more and more drugs to the mix. I went from an extreme athlete to a cripple in a month’s time with spontaneous tendon ruptures, one while watching TV, cartilage lesions that required a cartilage transplant, ligament damage, joint pain all over, torn lumbar muscle, half a dozen bulging discs out of nowhere, an umbilical hernia, DVT in my chest and arms, bloated failing veins carved from 13 entry points so far, more to come, broken blood vessels, pulmonary edema, collapsed lung, pleurisy, non-smoker’s COPD, chronic diarrhea, rapid fluctuation in blood pressure, blood sugar variations leading to blackouts, wounds won’t heal and old wounds reappear. My teeth are crumbling out of my mouth, my nails fell off and came back with ridges and defects, my hair fell out and came back like I was 20 years older, I have damage to vision, hearing, taste, smell and touch. My mind has suffered cognitive and emotional anguish beyond description. There are hundreds of other problems ranging from minor to disabling. I now live with my sister so she can help take care of me and actually, we help take care of each other because she too is floxed, as is my father. There is clearly a genetic component to who has the most trouble with these drugs, although everyone will have an ADR eventually if they keep taking them. Each round is another game of Russian roulette.
Thank God the world is finally catching on. This class of drugs completely destroyed my life. My health, marriage and finances are all in ruins. From tendon problems, cdiff, suicidal thoughts the compete degeneration of a previous spinal fusion, chronic pain and insomnia. I’ve stuggled for real.
Thank you so much for sharing this important FDA warning about Fluoroquinolone antibiotics!! These are some dangerous drugs that should only be prescribed for life threatening conditions not for a first line of defense. I have permanent bodily damage because of this antibiotic and have lived in pain the last 5-1/2 years! There are millions of us out there affected by these adverse reactions!
These drugs are used prophylactically, just in case!
That happened to me 12 years ago. My life changed forever!