Doctors Still Overprescribing Fluoroquinolones Despite Risks

July 5, 2022 – When Amy Moser had a easy urinary tract an infection in her late 20s, her physician prescribed Cipro, a robust antibiotic used to deal with anthrax and a few of the most fearsome bacterial infections.

Nearly 2 weeks after she completed her therapy, her left kneecap dislocated whereas she was making an attempt on a swimsuit at a retail retailer. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, adopted by three Achilles tendon tears.

“That’s when I fell apart,” says Moser, a Phoenix well being blogger and ebook creator. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”

Moser’s medical doctors had no reply for what was making her accidents, all of which required surgical fixes. A married mom of three, she was in any other case wholesome and match. So, after her third Achilles tear, she turned to the FDA’s web site for solutions. There, she discovered many warnings about uncomfortable side 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 search led to FDA warnings and articles about the potential for 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 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 right tendon ruptures and accidents, together with a double-knee substitute this yr.

“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 hardly an remoted case. Since the Eighties, greater than 60,000 sufferers have reported a whole bunch of hundreds of significant occasions linked to fluoroquinolones to the FDA, together with 6,575 studies of deaths.

The most typical uncomfortable side effects had been tendon rupture, in addition to neurological and psychiatric signs. But specialists estimate only one% to 10% of such occasions are reported to the FDA. That means that fluoroquinolones might need harmed a whole bunch of hundreds of individuals within the United States alone, says Charles Bennett, MD, a hematologist on the University of South Carolina’s College of Pharmacy in Columbia.

Yet regardless of the numerous affected person studies and FDA warnings on harmful uncomfortable side effects, many medical doctors proceed to wrongly prescribe fluoroquinolones for easy urinary tract infections, sinus infections, and respiratory points 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 scholar with the Johns Hopkins Center for Health Security.

“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 deal with sure bacterial infections.

FDA-approved fluoroquinolones embrace ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic variations of those brand-name medicines are additionally in the marketplace, making them among the many most prescribed antibiotics within the U.S.

Over the previous 2 a long time, a variety of bodily and psychological well being uncomfortable side effects have been tied to fluoroquinolones. As a results of these “adverse event reports” and analysis printed in medical literature, the FDA has required an escalating sequence of warnings and security labeling modifications for medical doctors who prescribe these medication.

• In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an elevated danger of tendinitis and tendon rupture in sufferers prescribed these meds.
• In 2011, the company required the warning label to incorporate dangers of worsening signs for these with myasthenia gravis, a power autoimmune illness that causes muscle weak point, imaginative and prescient issues, and speech issues.
• In 2013, regulators required up to date labels noting the potential for irreversible peripheral neuropathy (critical nerve harm).
• In 2016, the FDA issued its strongest warning towards using such antibiotics for easy bacterial infections – resembling uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying 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 security labeling modifications to incorporate warnings in regards to the dangers of aortic aneurysm – a life-threatening enlargement of the primary vessel that delivers blood to the physique – and psychological well being uncomfortable side effects and critical blood sugar disturbances.

But FDA regulators have stopped wanting barring fluoroquinolone use within the therapy of bacterial infections, citing the advantages for sure situations.

“For some sufferers, the advantages of fluoroquinolones might proceed to outweigh the dangers for therapy of significant bacterial infections, resembling pneumonia or intra-abdominal infections,” stated 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 research printed within the journal JAMA Network Open discovered the FDA’s warnings might have helped decrease prescribing of the medication in Medicare sufferers. But not all medical doctors have been aware of these warnings, researchers discovered.

“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 ought to do extra to highlight the hazards of fluoroquinolones and require medical doctors and sufferers to signal guidelines consent varieties to point out they’re conscious of the potential uncomfortable side effects of those medication.

Rachel Brummert, a affected person advocate who sits on an FDA client advisory board, believes the FDA wants to enhance its communication to medical doctors on fluoroquinolone dangers and get harder with those that proceed to inappropriately prescribe the medication.

“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 consultant on the FDA’s Medical Devices Advisory Committee.

As an instance, she factors to Australia’s medical legal guidelines requiring medical doctors and sufferers to signal a guidelines earlier than any fluoroquinolone prescription is permitted.

“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 need prevented the hurt from taking Levaquin her physician prescribed for a suspected sinus an infection in 2006.

Soon after she started taking the antibiotic, she ruptured her Achilles tendon, requiring surgical procedure. By 2009, she’d had three ruptures, every needing surgical fixes. To date, she’s had greater than 30 surgical procedures to right tendon ruptures. She’s additionally had seizures, blood stress points, melancholy, power ache, and reminiscence issues she attributes to taking Levaquin.

As it seems, her physician misdiagnosed her situation – a misstep that might have been averted with a system like Australia’s, which requires medical doctors to confirm the presence of a bacterial an infection via a easy check earlier than 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 medical doctors persevering with to prescribe fluoroquinolones for easy infections? Adalja and different specialists say a number of issues are at work.

For one factor, Adalja notes, fluoroquinolones are broad-spectrum antibiotics which can be efficient towards harmful germs, together with “gram-negative” bacterial infections, and are “100% bioavailable.” That means they’re as efficient when given in tablet type as they’re if put straight right into a vein. So they can be utilized in an outpatient setting or to permit a affected person to be discharged from a hospital sooner as a result of they don’t want an IV to obtain therapy.

“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 a part of the bigger pattern of antibiotic overuse. That is driving up antibiotic resistance, which in flip is one other factor main medical doctors to show to Cipro and different fluoroquinolones after different medication have confirmed 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 sufferers must be cautious every time a physician prescribes a fluoroquinolone, or any drug to deal with a suspected an 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’re sharing their tales to lift consciousness of the hazards of fluoroquinolones.

Moser has printed a ebook on her experiences, The Magnificent Story of a Lame Author, and supplies a wealth of client sources on her weblog: 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 dietary supplements her advocacy work as an FDA adviser with helpful supplies she supplies on her web site: 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 sufferers?

• Check out the FDA’s Drug Safety Communication on Fluoroquinolones on-line to be taught extra in regards to the dangers and advantages of those highly effective antibiotics.
• If you consider you’ve been harmed by fluoroquinolones, go to the FDA’s MedWatch web site to report your experiences.

Brummert additionally advises sufferers to ask 12 important questions of any physician who desires to prescribe a fluoroquinolone, together with the next listed on her web site:

1. For what situation is that this remedy prescribed, and is there one other drug particular to my situation?
2. What are the dangers related to this remedy, and do the advantages outweigh them?
3. Will this remedy work together with my different medication and/or different well being situations?
4. What are the “black box” warnings for this remedy, and the place can I report adversarial 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 agrees that you need to be your personal affected person advocate and never merely take a physician’s recommendation on any medical subject with out having 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.”