Antibiotics are a class of drugs that can effectively stop dangerous bacterial infections in their tracks by eliminating the growth of bacteria or killing the bacteria. But, these drugs carry unwanted and serious side effects that are often not known prior to going to market.

In the case of the fluoroquinolones (FQs) currently on the market, case studies now clearly indicate that previously healthy individuals with no prior medical history can develop life-altering symptoms while on FQs and even after stopping the course of medication.  In some cases, it took as little as a couple of courses of the medication before life-altering symptoms surfaced. Many individuals in recent case studies also experienced severe progressive and delayed symptoms. And, sadly, despite great efforts to return to a healthy life, some individuals were unable to return to their previously vigorous and healthy lifestyle.

Drug medication guides contain information about specific reported symptoms. But, until now, none of the literature has warned of the risk of a serious, persistent and delayed multi-symptom adverse event triggered by FQ use.

 

FDA Advisory Panel Recommends That The FDA Take Regulatory Action – Popular Antibiotics Linked to a Disability

 

FQAD has been found to be a substantial disruption to a person’s ability to conduct normal life functions and it can trigger injuries throughout the body. Case studies of previously healthy, highly functioning individuals highlight the fact that patients need to promptly report any adverse effects that arise on FQ use to their physicians, in order to limit risk of progression.   Since many of the adverse events are progressive and/or delayed, it is imperative that consumers remain aware of their health issues while using FQs and are warned about the risk of FQAD.

During a recent FDA committee advisory meeting, more than 30 members of the public spoke to a panel of recognized experts about the injuries they believe are linked to their FQ treatment. This advisory panel overwhelmingly agreed that there needs to be changes made to the FQ labels and recommended as much to the FDA. During testimony, one witness noted that she had been in perfect health when she took Levaquin to treat non-life threatening pneumonia, but after nine pills she found herself in excruciating pain for over a year. A year later, this witness still walks with crutches.

Naming this disability and getting information about all the potential symptoms to consumers and health care providers should make a significant positive impact towards treatment. With the label changes, it is anticipated that FQs will be used in the treatment of life-threatening diseases but will be reserved for illnesses that may resolve with time.

Furthermore, the first step towards health is establishing an accurate diagnosis. The FDA took a big step towards helping those injured through FQ usage by acknowledging this disability and we look forward to helping to get information out to the public about this risk.

Side Effects and Symptoms of FQAD

As with all drugs, FQs have the potential for adverse events, many of which were not known at the time the drug went to market. It is often the case that as more patients are exposed to a particular drug, adverse events begin to surface in a number that may require reporting to the public and the FDA. The responsibility to monitor the safety of the products and communicate any new information remains with the manufacturer of these drugs.

The FDA refers to the side effects and symptoms of FQAD as a “constellation of symptoms.” They occur across multiple body systems including musculoskeletal, cardiac, dermatologic, neurologic and neuro-psychiatric risks. A list of symptoms can be found on our detailed Instant Case Evaluation on this website, but studies show that vulnerable individuals present symptoms in different ways and it is imperative that all side effects are reported to physicians while on a course of FQs or even after completing the course of medication.

Our lawyers anticipate that the FDA will change the label on popular antibiotics such as Levaquin, Cipro, Avelox, Noroxin, Floxin and Factive to warn about the risk of Fluoroquinolones-Assisted Disability (FQAD).

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 FQ 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 FQs 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.

Side Effect/Symptom System Affected
Aortic Aneurysm Aortic System
Aortic Dissection Aortic System
Tendon Rupture Musculoskeletal System
Tendinitis Musculoskeletal System
Other Joint / Tendon or Muscle Injury Musculoskeletal System
Anxiety Neuropsychiatric System
Cognitive Impairment Neuropsychiatric System
Confusion Neuropsychiatric System
Delusional Behavior Neuropsychiatric System
Depression Neuropsychiatric System
Feeling Dizzy Neuropsychiatric System
Hearing Voices, seeing things or other hallucinations Neuropsychiatric System
Intracranial Pressure Neuropsychiatric System
Neurosis Neuropsychiatric System
Nightmares Neuropsychiatric System
Paranoia Neuropsychiatric System
Psychosis Neuropsychiatric System
Pseudotumor cerebri Neuropsychiatric System
Seizures Neuropsychiatric System
Suicidal Thoughts Neuropsychiatric System
Tremors Neuropsychiatric System
Trouble Sleeping Neuropsychiatric System
Abnormal Sensations in Arms Hands Legs or Feet Nervous System
Abnormal sensitivity to touch, heat, cold, etc. Nervous System
Abnormal vibratory sense with an extremity Nervous System
Muscle weakness in arms, hands, legs or feet Nervous System
Numbness in arms, hands, legs or feet Nervous System
Pain in arms, hands, legs or feet Nervous System
Paralysis Nervous System
Prickling sensation in arms, hands, legs or feet Nervous System
Permanent nerve damage in arms, hands, legs or feet Nervous System
Hearing loss Sensory System
Myasthenia Gravis (MG) exacerbation Sensory System
Vision Loss Sensory System
Severe Photosensitivity/Phototoxicity reactions which may manifest as exaggerate sunburn reactions (eg burning, erythema, exudation, vesicles, blistering or edema) Sensory System
Cardiac arrhythmia Cardiovascular System
QT Prolongation Cardiovascular System
Torsades de Pointes (TdP Warning) Cardiovascular System
Other Cardiovascular issues Cardiovascular System
Skin abnormalities including lack or increased sweating Skin Abnormalities


 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 reations, 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.