What are Fluoroquinolones (FQs)?

FQs are one of the most prescribed classes of antibiotics. In 2010, Levaquin (levofloxacin) manufactured by Ortho-McNeil, was the best selling antibiotic in the United States with sales of $1.3 billion in 2010, before it went generic in 2011.

The other FQs that remain on the market are Avelox (moxifloxacin), Cipro (ciprofloxacin), Noroxin (norfloxacin), Factive (gemifloxacin) and Floxin ofloxacin. In addition, there are many generic versions of these newer FQs that go by their generic names.

While several FQs remain on the market in the U.S., a lot of FQs have been withdrawn as a result of severe adverse reactions, some of which resulted in death.

 

Now Withdrawn FQs

Drug Name Brand Name Removed From Market
Trovafloxacin Troval 1999
Gatifloxacin Tequin 2006
Grepafloxacin Raxar 1997
Temafloxacin Omniflox 1992
Sparfloxacin Zagam 2001

 

Fluoroquinolones are over-prescribed

 

FQs are broad-spectrum antibacterial drugs. They are referred to as “broad-spectrum” antibiotics because these drugs act against a wide range of disease-causing bacteria. Cipro, Levaquin, Avelox, Floxin, Factive and their generic counterparts have been prescribed for urinary tract infections, sinusitis, bronchitis, earaches and other illnesses that are likely to resolve without the need for antibiotics.

The CDC reports that approximately 50% of antibiotic prescriptions written in the outpatient setting are unnecessary. In fact, more than five prescriptions are written each year for every 6 people in the United States.

 

Our lawyers anticipate that the FDA will change the FQ labels and when it does, it may open the door for litigation against the manufacturers of these medicines.

 

FQAD Injuries are underreported to the FDA

 

FQs package inserts document many serious adverse events as a result of voluntary reporting to the FDA. But, there is a lack of information about the multi-symptom problems that occur in FQAD. To date, there have been no long-term studies done on former users of antibiotics which has led to a lot of frustration in getting an accurate diagnosis for injured individuals.

Adverse reactions that were likely linked to FQ usage were likely not reported as such or they were not reported as all. Some injured individuals report a diagnosis of “fibromyalgia” since the symptoms showed up weeks and months after discontinuing the FQ treatment and can present in a similar way – widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues.

But, even if these symptoms were linked to the FQ usage and voluntarily reported to the FDA, it is likely that the number of reports is drastically more than is currently known. According to FDA estimates, only about ten percent of all adverse events are actually reported to the adverse event database and therefore the number of serious side effects known to occur in these drugs is likely approximately ten times the FDA numbers.

 

 

The Manufacturers Did Not Properly Warn of The Risk of FQAD

This isn’t a single side effect of an effective drug used in the treatment of a life threatening injury. This is a life changing disability that is coming out of an antibiotic prescribed in the treatment of urinary tract infections, sinusitis, bronchitis, earaches and other illnesses that are likely to be resolved on their own.

FQAD Research and Support

 

In recent years, there has been a growing amount of attention in the media and, specifically within social media, as a result of some very vocal advocates that are looking to get word out about those suffering from FQ symptoms.   These forums allow individuals to post their stories regarding the life changing symptoms they believe they experienced as a result of FLQ use. Some of these groups include Floxie Hope, My Quin Story, Fluorquinolone Stories, Fluoroquinolone Antibiotic Toxicity Advocacy and Activism Page and the Fluoroquinolone Wall of Pain.

In addition, there are several academic researchers and doctors that are working to determine the impact of FQs. Amongst others, Dr. Charles Bennett, Dr. Beatrice Golomb and Dr. Mark Noble continue to research the effects that FQs have on individuals.

Dr. Charles Bennett, who heads up the Southern Network on Adverse Reactions (SONAR), wants to add a black box label to FQs that warns of “possible mitochondrial toxicity” and “serious psychiatric events.” A black box label is the strictest warning put in the labeling of prescription drugs by the FDA when there is reasonable evidence of an association of a serious hazard with the drug.

According to Dr. Bennett, the FDA has received more than 150,000 reports of adverse events and 2,400 reports of deaths associated with Levaquin and ciprofloxacin. SONAR has gathered testimony from thousands of patients all across the country who have experienced severe symptoms after taking FQs and he notes that the largest problem is that most patients – even most doctors – don’t know these serious issues exist.

Dr. Beatrice Golomb, University of California San Diego, published a paper with four case reports in BMJ in September 2015.   The cases examined in depth were of four previously healthy, employed adults without significant prior medical history in each of whom symptoms developed while on FQs, with progression that continued following discontinuation evolving to a severe, disabling multi-symptom disability.

Each of the four cases in Dr. Golomb’s case report points to the need to properly education physicians and patients with regards to the possibility of a severe, disabling, multisystem problem that can be persistent, progressive and/or delayed.

Dr. Mark Noble is a Professor of Neurology, Genetics, and Neurobiology and Anatomoy at University of Rochester School of Medicine and is Director of the University of Rochester Stem Cell and Regenerative Medicine Institute. Dr. Noble has been doing research into the toxicity of Levaquin and other FQs. Dr. Noble did preliminary studies to determine why FLQs are toxic to a surprising number of idividuals. His research, which he discusses on My Quin Story, shows that a combination of Levaquin with a regularly used over the counter medication, naproxen (the active ingredient in Alleve), causes a very toxic effect at a short exposure period.

Dr. Noble notes that it is imperative that further research into the combination of FQs with other agents is performed to determine toxicities.

 


 References

[1] http://www.myquinstory.info/wp-content/uploads/2015/10/FQ-induced-serious-persistent-multisx-adverse-effects-BMJ-Case-Reports.pdf[2] http://www.dailyfinance.com/2011/02/27/top-selling-drugs-are-about-to-lose-patent-protection-ready/

[3] Glaxo pulled Raxar off the market after it was suspected as the in the death of 13 patients. http://www.latimes.com/nation/la-122001raxar-story.html

[4] Abbott pulled Omniflox off the market after reports of 50 serious adverse reactions including 3 deaths. https://www.pharmamedtechbi.com/publications/the-pink-sheet/54/023/abbott-withdrawal-of-omniflox-follows-50-serious-adverse-reactions

[5] http://www.cdc.gov/getsmart/community/programs-measurement/measuring-antibiotic-prescribing.html

[6] http://www.usatoday.com/story/news/nation/2013/04/10/medication-antibiotic-overuse/2071899/

[7] http://well.blogs.nytimes.com/2012/09/10/popular-antibiotics-may-carry-serious-side-effects/

[8] FDA-Approved Medication Guide for Levaquin which notes serious side effects including Tendon rupture, serious allergic reactions, liver damage, central nervous system effects, intestine infection, changes in sensation and nerve damage, serious heart rhythm changes, joint problems, changes in blood sugar and sensitivity to light. http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf

[9] Statement of Janet Heinrich, Associate Director Health Financing and Public Health Issues Health and Human Services Division, before the US General Accounting Office, 2/1/2000 http://www.gao.gov/new.items/he00053t.pdf

[10] http://academicdepartments.musc.edu/pr/newscenter/2015/antibiotic-warning.html#.VjD1N2SrR-U

[11] Golomb BA, et, al BMJ Case Rep 2015. Doi:10.1136/bcr-2015-209821.