July 5, 2022 – When Amy Moser had a easy urinary tract an infection in her past due 20s, her physician prescribed Cipro, an impressive antibiotic used to regard anthrax and one of the maximum fearsome bacterial infections.
Just about 2 weeks after she completed her remedy, her left kneecap dislocated whilst she was once attempting on a go well with at a retail retailer. In a while later on, she had painful ligament ruptures in her wrists, then her shoulder dislocated, adopted by way of 3 Achilles tendon tears.
“That’s when I fell apart,” says Moser, a Phoenix well being blogger and guide writer. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”
Moser’s docs had no resolution for what was the reason for her accidents, all of which required surgical fixes. A married mom of 3, she was once another way wholesome and have compatibility. So, after her 3rd Achilles tear, she became to the FDA’s website online for solutions. There, she discovered many warnings about unwanted effects of Cipro, Levaquin, and different so-called fluoroquinolones, together with dangers for tendon and ligament accidents.
“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’” she recollects.
Her seek resulted in FDA warnings and articles about the potential of tendon and ligament ruptures with fluroquinolones.
“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list … and I realized that I’d just been prescribed that before everything started,” she says.
That was once 12 years in the past. Since then, the FDA has issued extra warnings about fluoroquinolone dangers. In that point, Moser, now 40, has had greater than 30 surgical procedures to proper tendon ruptures and accidents, together with a double-knee alternative this 12 months.
“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”
Moser’s is infrequently an remoted case. For the reason that Eighties, greater than 60,000 sufferers have reported masses of hundreds of significant occasions related to fluoroquinolones to the FDA, together with 6,575 experiences of deaths.
The most typical unwanted effects had been tendon rupture, in addition to neurological and psychiatric signs. However mavens estimate just one% to ten% of such occasions are reported to the FDA. That implies that fluoroquinolones would possibly have harmed masses of hundreds of other people in the USA by myself, says Charles Bennett, MD, a hematologist on the College of South Carolina’s Faculty of Pharmacy in Columbia.
But in spite of the numerous affected person experiences and FDA warnings on bad unwanted effects, many docs proceed to wrongly prescribe fluoroquinolones for easy urinary tract infections, sinus infections, and respiration problems higher handled with much less dangerous antibiotics.
“There probably is over-prescription by primary care doctors, for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious illness specialist and senior student with the Johns Hopkins Middle for Well being Safety.
“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors … but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
FDA Warnings on Fluoroquinolones
Fluoroquinolones are a category of broad-spectrum antibiotics used for many years to regard sure bacterial infections.
FDA-approved fluoroquinolones come with ciprofloxacin (Cipro), ciprofloxacin extended-release capsules, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). Greater than 60 generic variations of those brand-name medications also are in the marketplace, making them a few of the maximum prescribed antibiotics within the U.S.
Over the last 2 many years, a variety of bodily and psychological well being unwanted effects were tied to fluoroquinolones. Because of those “adverse event reports” and analysis revealed in scientific literature, the FDA has required an escalating collection of warnings and protection labeling adjustments for docs who prescribe those medication.
- In 2008, the FDA first added a “black box” caution to fluoroquinolones, mentioning an higher chance of tendinitis and tendon rupture in sufferers prescribed those meds.
- In 2011, the company required the caution label to incorporate dangers of worsening signs for the ones with myasthenia gravis, a prolonged autoimmune illness that reasons muscle weak spot, imaginative and prescient issues, and speech issues.
- In 2013, regulators required up to date labels noting the opportunity of irreversible peripheral neuropathy (severe nerve injury).
- In 2016, the FDA issued its most powerful caution in opposition to using such antibiotics for easy bacterial infections – reminiscent of clear-cut urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – pronouncing the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system … outweighs the benefits for patients.”
- And in 2018, regulators required protection labeling adjustments to incorporate warnings in regards to the dangers of aortic aneurysm – a life-threatening expansion of the primary vessel that delivers blood to the frame – and psychological well being unwanted effects and severe blood sugar disturbances.
However FDA regulators have stopped wanting barring fluoroquinolone use within the remedy of bacterial infections, mentioning the advantages for sure stipulations.
“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”
In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.
“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. … Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”
Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.
Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.
“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.
As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.
“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”
Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.
Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.
As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.
“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would I have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’
“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
Should Guidelines Be Stronger?
So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Adalja and other experts say several things are at work.
For one thing, Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.
“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”
But Adalja says the over-prescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.
“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”
That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.
“Anytime a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’”
What You Can Do
Brummert and Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.
Moser has published a book on her experiences, The Magnificent Story of a Lame Author, and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.
“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.
Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.
“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”
The upshot for patients?
- Check out the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
- If you believe you’ve been harmed by fluoroquinolones, consult with the FDA’s MedWatch website online to document your reviews.
Brummert additionally advises sufferers to invite 12 crucial questions of any physician who desires to prescribe a fluoroquinolone, together with the next indexed on her website online:
- For what situation is that this drugs prescribed, and is there every other drug explicit to my situation?
- What are the dangers related to this drugs, and do the advantages outweigh them?
- Will this drugs have interaction with my different medication and/or different well being stipulations?
- What are the “black box” warnings for this drugs, and the place can I document antagonistic occasions?
“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’”
Moser concurs that it’s a must to be your personal affected person recommend and now not merely take a physician’s recommendation on any scientific factor with no need a deeper dialog.
“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.
“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”
