Fluoroquinolones

Fluoroquinolones, a commonly prescribed class of antibiotics, is a long story of what can go wrong with what is perceived as a safe product, and the recent FDA warning only adds to the controversy and will lead to the filing of antibiotic lawsuits. Common fluoroquinolones are: Avelox®, Cipro®, and Levaquin®. Fluoroquinolones (FLQ) are among the most prescribed antibiotics so adverse events can have significant public health implications for many.

The early controversy over FLQ involved tendonitis and Achilles tendon rupture. In the early 90’s medical research focused on tendon rupture. Researchers speculated that FLQ’s affected collagen in some way because tendons are composed collagen fibers. Collagen is a unique structure that is stronger than steel. It is found throughout the body in cartilage, blood vessels, the cornea, muscles and the gastrointestinal tract.

There are several types of collagen. Type I and type III collagen comprise the majority of collagen in the Achilles tendon. Approximately 90% of collagen in normal tendons is Type I and 10% is Type III. Over the years medical studies have coalesce around the proposition that FLQ interfered with collagen fibrils found in Type I collagen. Medical studies indicate discuss FLQ’s such as Cipro exert a negative effect on tendon structure or its healing process through the mechanism by up-regulating gelantinase (MMP-2) expression. According to the Tsai study, type I collagen is degraded after treatment with ciprofloxacin. Over the years fluoroquinolone tendon ruptures are a recognized complication of this class of drugs.

So how is this related to an aortic rupture or aortic tear? Well the aorta is the largest artery in the body and it distributes oxygenated blood throughout the body. The aorta is composed of collagen with type I and type III comprising the majority of the collagen. When the strength of the aortic wall is weakened by a degradation of the type I collagen then an aortic aneurysm is a substantial risk factor. Further, the aorta is under a great deal of stress as it puts oxygenated blood through the body.

In a study titled: “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study” the authors found that fluoroquinolones may contribute to aortic aneurysms. The study involved 1,744,360 patients who received at least one fluoroquinolone prescription compared to 1,086,410 patients who received no fluoroquinolone prescription. In the study current fluoroquinolone use lead to increased hazard of aortic aneurysms of 2.72. The study authors also tested subgroups and the results were similar. Pathology sections of aortic aneurysms and aortic dissections demonstrate abnormalities of collagen content, concentrations and ratios.
In December, 2018 the FDA issued an alert to consumers and doctors that a review of the safety data found an increased risk of aortic rupture or tears in the aorta in conjunction with fluoroquinolone antibiotic use.

This follows the FDA label change in 2008 where the FDA required the manufacturers of fluoroquinolones to put a Black Box warning on their label alerting users and prescribing physicians of the substantial risk of tendon ruptures. However, the label remained silent about a more deadly adverse reaction – aortic aneurysm.

What Did They Know?

Often times when analysis begins on a potential case for litigation a simple question is posed should they have known? In FLQ aortic aneurysm cases the answer,is based on the many years of science surrounding tendon ruptures, they should have known and they should have studied. The similarities between tendon composition and the aorta are too great to dismiss. This litigation is a classic failure to study and warn case.  See FDA warning:

https://www.fda.gov/Drugs/DrugSafety/ucm628753.htm

In FLQ litigation preemption of generic drugs will have a substantial impact on many cases. Briefly, in Pliva v. Mensing, the United States Supreme Court ruled that lawsuits against generic drug manufacturers are preempted by federal drug regulations which require a generic drug label to match the brand warning label word for word regardless of mounting evidence that a generic drug carries a risk far greater than what is disclosed in the label. The case has essentially eliminated all claims form users of generic drugs from bring claims against generic manufacturers. There are a few exceptions or nuances to this rule but not many.

For many users of generic Cipro, Levaquin or Avelox who developed an aortic aneurysms or aortic dissection, this means they will be unable to successfully file lawsuits. However, if the brand name product was used these individuals may be able to file a lawsuit. If you or a loved one has questions about filing an antibiotic lawsuit call us at 1-800-745-4050.

Antibiotic Lawsuit Case?

We will start by analyzing your prescription medicine history paying particular attention to the national drug code to determine who manufactured the FLQ you used. Once we have identified the manufacturer we will let you know your options. Hopefully, a brand product was used. If so then additional medical records will be reviewed.

We provide each client personal attention and the respect they deserve. We will work hard and do the best we can for you. We make no promises other than the one of hard work for you. If you have questions, please call 1-800-745-4050 or contact us by clicking the image of the question mark below.

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