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Koester & Bradley Pharmaceutical Udate: FDA Updates Warning for Fluoroquinolone Antibiotics

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 Serious Disabling and Potentially Permanent Side Effects Possible with Cipro, Levaquin, and Avelox

Koester & Bradley Champaign Levaquin LawyersThe U.S. Food & Drug Administration (FDA) has issued its strongest warning about fluoroquinolones (FLQ), a very popular type of  antibiotics.  These antibiotics are prescribed in both oral and injection forms. This warning is due to an increasing number of reports of serious, even life threatening side effects.

According to the FDA, its studies found FLQs cause a number of musculoskeletal peripheral and central nervous system side effects including:

  • Tendinitis (an ailment that impacts the ligaments and tendons that connect bones)
  • Tendon rupture
  • Numbness, tingling or a pins & needles sensation in the arms and/or legs
  • Muscle weakness
  • Joint pain and/or Joint swelling
  • Anxiety, Depression
  • Hallucinations
  • Suicidal Thoughts

The FDA is warning healthcare professionals not to prescribe these antibiotics for specific issues where the possibility of side effects can out weigh the benefits.  These issues include:

  • Acute bacterial sinusitis
  • Chronic bronchitis
  • Uncomplicated urinary tract infections

This new warning is the latest of a list of safety issues associated with FLQs that have come to light in the last few years. Recently a number of studies linking FLQs to the increased risk of aortic aneurysms and aortic dissections.  Clearly, these types of side effects are significantly worse than the ailments which the antibiotic aims to address.  The problems with this class of drugs which include “household names” such as Cipro, Proquin, Factive, Levaquin, Noroxin, and their accompanying generics were initially addressed in 2008 when the FDA suggested a black box warning on the antibiotics.

This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. The FDA left the burden on the doctors to advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.

Now even stronger warning are have been approved by the FDA as of last last month (July 2016).  Primarily, the new warnings suggest that patients and doctors explore other options that FLQs for the issues above.Koester & Bradley Urbana  bad Drug lawyers This warning is based on an FDA safety review has shown that oral and injectable fluoroquinolones for systemic use are associated with disabling and potentially permanent, serious side effects that can occur together. Consequently, the FDA required and approved label changes for all systemic fluoroquinolone antibacterial drugs to reflect this new safety information.

Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.

These drugs are massively popular and heavily prescribed.   With more than 22 million Americans prescribed Avelox, Cipro, and Levaquin, the brand name for the antibiotics commonly used to treat bacterial infections, such as urinary tract infections or sinus infections, the new warnings are aimed at a very large part of the population.

There have been mass tort lawsuits regarding these drugs coordinated in Illinois for some time now, and the new labeling requirements add another layer to the story.

The focus of these consolidations of lawsuits to obtain compensation for victims of the drugs.  In these cases, the Avelox lawsuit targets the manufacturer, Bayer HealthCare. The Levaquin lawsuit targets Janssen Pharmaceuticals a Johnson & Johnson Co.

As more information comes from the FDA or the consumer protection community, Koester & Bradley will keep you informed in this publication or through the Illinois Plaintiffs Lawyer.  Remember, side effects from FLQs can be permanent and result in disability including possible loss of jobs and health insurance resulting in the major medical bills and myriad financial and family issues.  If you or a loved one is taking FLQs or has experienced and adverse side effects, please consult with your doctor.  Further, it is important to stay informed so feel free to get in touch with any questions.

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  1. Mark A. Girard says:
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    Thanks so much for doing an article on the FDAs long overdue warnings and changes to the labels for these incredibly dangerous drugs. My name is Mark Girard and I am the senior admin for the largest of many different groups that work pretty closely together to me the needs of the exploding fluoroquinolone (FQ) community. I have not seen it referred to as FLQ. It is important for people to realize that these are not traditional antibiotics cultured from living organisms, rather, they are simply toxic chemicals that slaughter bacteria of all sorts, which is why lazy doctors will go to them without checking to see which drug is the best for the bug. Doctors are absurdly and dangerously over-confident in all the different drugs they are peddling but in the case of FQs, they are even more overconfident than usual and this is because they have been intentionally misled by their friendly drug reps. This is why, even though this is the single most reported class of drugs, doctors are totally missing us. Med-Watch, FDA’s broken reporting system usually gets around 4% of their reports from patients but in our case it is over 85%. This is a catastrophe of epic proportions, a disaster so massive it is impossible to count the trillions of dollars it will set the world back as we struggle to take care of tens of millions of people who have suffered HORRIFIC damage. I will share this link in Fluoroquinolone Toxicity Group so some others can come here to comment and also to let people know you are here. Thanks again, Mark Girard

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