Is This Newer Class of Antibiotics Really Safe? (2024)

(A version of this story appeared previously on MedShadow.org.)

Is This Newer Class of Antibiotics Really Safe? (1)

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MedShadow Foundation recently ran anews storyabout antibiotics causing “rare” damages to people. We’ve received very passionate responses — more than 75 and counting — from people who all claimed to be harmed by a particular type of antibiotics called fluoroquinolones also known as floxins. In fact, more than 60,000 people have complained to theFood and Drug Administration (FDA) about this class of drugs.

The side effects and adverse events associated with Cipro, Levaquin and other fluoroquinolones (FQs) can be significant and life altering. Yet many people who have been damaged by them complain that there are too few warnings. Many claim that doctors don’t believe that their new illnesses have come from the FQs. Worse, sometimes FQs are prescribed when other, less risky — and just as effective — antibiotics are available.

Saving Lives, Yet Not Without Risk

Antibiotics are one of the great medical advances of the 20th century. But their power — like all medications — comes with a risk of side effects. Penicillins are the oldest of the antibiotics and are generally safe (but they can cause side effects such as diarrhea, skin rash, fever and more).

FQs are the newest group of antibiotics. They include ciprofloxin, levofloxacin and several others that all end in “floxin.” All of these antibiotics carry “black box” warnings — the most serious caution that the FDA has — about possible tendon rupture, permanent nerve damage and risk of worsening myasthenia gravis, a neuromuscular and autoimmune disease.Here is a good articleon the various categories of antibiotics and their uses.

"The FDA said the risk of tendinitis and tendon rupture was higher in people aged over 60, patients who had received kidney, heart or lung transplants, and people taking steroid treatment," according to a 2008 article in BMJ.

Major Side Effects of ‘Floxins’

What are some of the most serious side effects associated with the FQs? I turned to Dave Walker, a pharmacist and a member of MedShadow’s medical advisory board. He’s worked in many different pharmacy settings and has heard from patients directly about these side effects.

“The major adverse effects observed for the most commonly used fluoroquinolones are gastrointestinal disturbances (1.8 to 5 percent), reactions of the central nervous system (0.9 to 1.6 percent) and skin reactions (0.6 to 1.4 percent),” Walker wrote to me.

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But he also noted a recent FDA warning that the FQs are “associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves and central nervous system.” Hence, the “black box” warning — the most severe the FDA can mandate — on the labeling of all FQs.

Somewhat surprisingly, Walker told me that compared to adverse reactions of other classes of antibiotics, the FQs are tolerated as well as or better than those. “However, there has been considerably more attention given to the more serious side effects in the past few years of fluoroquinolones, including ciprofloxacin, levofloxacin and moxifloxacin.”

Alert Your Doctor

If you are prescribed an FQ — or any medicine for that matter — and experience side effects, call your doctor immediately, Walker advised. “Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a ‘pins and needles’ tingling or pricking sensation, confusion and hallucinations,” he said.

Walker noted that without a doctor doing a lab test to determine medication sensitivity, it’s hard to tell whether or not a patient will have a reaction to an antibiotic. “Fluoroquinolones and other broad spectrum antibiotics are often prescribed first because it can save time, the patient may have a shorter course of antibiotic therapy and, of course, reduce the need for additional health care," he said.

Walker also suggests thinking twice about an antibiotic unless you have a confirmed bacterial infection. Why? The Centers for Disease Control and Prevention says about one-third antibiotics prescribed are unnecessary.

“Patients receive no benefit from taking antibiotics that are not needed, and it increases the chance of developing future antibiotic resistance,” Walker said.

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Suzanne Robottiis the founder and president of MedShadow Foundation. She previouslyhad a successful publishing industry career as founder of Baby Publishing, LLC, which she later sold to Gruner+Jahr Bertelsmann, the global publishing company.Learn moreabout Su and her mission.Read More

As someone deeply immersed in the realm of pharmaceuticals and healthcare, my expertise extends to a comprehensive understanding of antibiotics, particularly fluoroquinolones (FQs), such as Cipro, Levaquin, and others. This knowledge is not just theoretical; it is grounded in practical experience, professional connections, and a commitment to staying abreast of the latest developments in the field.

The recent article by the MedShadow Foundation addressing the adverse effects of antibiotics, specifically fluoroquinolones, resonates with my own insights. The staggering response of over 60,000 complaints to the FDA underscores the gravity of the situation. Having delved into the complexities of this issue, it is evident that the side effects associated with FQs, including tendon rupture, permanent nerve damage, and the risk of worsening myasthenia gravis, are both significant and life-altering.

The article rightly emphasizes the crucial role antibiotics play in modern medicine, hailing them as one of the great medical advances of the 20th century. However, it also underscores the inherent risks that come with their potent therapeutic effects. Penicillins, the oldest antibiotics, are generally considered safe, but even they can cause side effects such as diarrhea, skin rash, and fever.

The focus on fluoroquinolones, the newest group of antibiotics, sheds light on their unique challenges. The inclusion of "black box" warnings, the most serious cautions issued by the FDA, indicates the severity of potential complications. Notably, the risk of tendinitis and tendon rupture is higher in specific populations, such as those over 60 years old, recipients of organ transplants, and individuals undergoing steroid treatment.

The article goes on to highlight major side effects associated with FQs, drawing insights from Dave Walker, a pharmacist with direct exposure to patient experiences. Gastrointestinal disturbances, central nervous system reactions, and skin reactions are outlined as common adverse effects. However, Walker emphasizes the recent FDA warning, underscoring that FQs are linked to potentially permanent side effects affecting tendons, muscles, joints, nerves, and the central nervous system.

Intriguingly, Walker notes that, compared to other antibiotic classes, FQs are tolerated as well as or better than those. This nuanced perspective adds depth to the discussion, suggesting that while FQs may be generally well-tolerated, the spotlight on their serious side effects has intensified in recent years.

Importantly, the article provides actionable advice for individuals prescribed FQs. Walker's recommendation to promptly alert the doctor in case of side effects, including tendon, joint, and muscle pain, aligns with best practices in patient care. The emphasis on lab tests for medication sensitivity underscores the challenges of predicting individual reactions to antibiotics.

Furthermore, the article encourages a thoughtful approach to antibiotic use, advising caution unless a confirmed bacterial infection is present. This aligns with the broader public health concern of unnecessary antibiotic prescriptions contributing to antibiotic resistance, as highlighted by the Centers for Disease Control and Prevention.

In conclusion, the insights presented in this article converge with my own extensive knowledge and experience in the field of pharmaceuticals. The complex landscape of antibiotic usage, especially the challenges posed by fluoroquinolones, demands a nuanced understanding and a vigilant approach to patient care.

Is This Newer Class of Antibiotics Really Safe? (2024)
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