fluoroquinolone toxicity survey

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Fluoroquinolone Toxicity Survey

February 2011

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Table of Contents• Description of Survey... 3• Interpretation of Data …4• Gender …5• Age …6• Ancestry …7• Baseline Health …8• Baseline Activity Level …9• Baseline Medications …10• Baseline Body Weight …11• Personal History of Autoimmune Disorders …12• Family History of Autoimmune Disorders …13• Typical Responses to Medications …14• Antibiotic Administered …15• Response after First Exposure to FQ …16• Levofloxacin Dose …17• Ciprofloxacin Dose …18• Moxifloxacin Dose …19• Duration of Treatment …20• Side Effects During Treatment …21• Early Cessation of FQ …22• Prescribing Doctor …23• Warnings from Doctor …24• Warnings from Pharmacist …25• Reading Drug Information Sheet …26• Knowledge of Side Effects …27• Type of Infection …28• FQ as a Frist Line Agent …29• Steroid Administration During Treatment …30• Cultures …31• Timing of First Symptoms …32• Symptom Cycles …33• Length of Cycles …34• Exacerbating Factors …35• Symptoms Related to Food …36• Resolution of Symptoms …37

• Duration of Continued Symptoms …38• Progression of Symptoms …39• Symptoms …40• Worst Symptom …41• Sites of Tendon Pain …42• Sites of Neuropathic Pain …43• Menstruation, Fertility, and Menopause …44• Microtears …45• Number of Tendon Ruptures …46• Timing of Tendon Ruptures …47• Signs of Impending Tendon Rupture …48• Number of Doctors Consulted …49• Any Doctor who Believes in FQ Toxicity …50• % of Doctors who Believe in FQ Toxicity …51• Diagnosis of FQ Toxicity …52• Doctors Found to be Helpful …53• Subsequent FQ Prescriptions …54• Alternative Diagnoses Considered …55• Abnormal Test Results …56• Treatments Utilized …57• Helpful Treatments …58• Most Helpful Treatment …59• Treatments that Worsened Symptoms …60• Surgery …61• Complications After Surgery …62• Work and Living Situation …63• Impact on Relationships …64• Emotional/ Psychological Impact …65• Disability …66• Legal Actions …67• Nomenclature …68• Future of FQ’s …69• Suggestions for Future Surveys …70• Disclosure …71

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Description of Survey

Objective: The adverse reactions associated with fluoroquinolone antibiotics are devastating but, surprisingly under-recognized by patients as well as by medical professionals. This survey was conducted to identify the demographics of those who suffer from fluoroquinolone toxicity and to demonstrate the magnitude of physical symptoms as well as the impact of these symptoms on the individual as a whole.

Methods: 130 individuals who have identified themselves as having fluoroquinolone toxicity responded to an online survey. The respondents were blinded to previous survey answers during the questioning. Data was gathered and is presented below.

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Interpretation of Data• Before looking at the following results, one must acknowledge some fundamental facts about the

interpretation of data.

• This data was collected in the form of a survey. Inherently, surveys are open to multiple forms of bias.

– The participants are answering both objective and subjective questions. While objective questions are relatively straightforward, subjective questions can be interpreted differently from one patient to another, and can also be answered with personal or emotional bias.

– The selection of participants is another form of potential bias in this study. Because fluoroquinolone toxicity is a newly recognized syndrome, there are not yet any reliable diagnostic tests. There is also a paltry sum of aggregate data that is easily accessible to physicians. Therefore, many of the participants in this survey are self-diagnosed. While this is obviously not an ideal circumstance, to date, it is the only patient population available for study.

– In addition to the lack of a verifiable diagnostic test, the participants may also not represent a realistic cross-section of individuals who suffer from fluoroquinolone toxicity. All participants had the knowledge and motivation to research the syndrome, find an online forum and participate in the survey. This process may have selected for a highly educated and computer savvy subpopulation.

• In spite of the abovementioned shortcomings of the available data, this information is a unique glimpse into the suffering of a very dedicated group of people. Their common interest in describing fluoroquinolone toxicity syndrome should serve as a springboard for further investigation into this devastating syndrome.

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GenderWhat is your gender?Gender Number

(n=137)Percent

Male 50 36

Female 87 64

• We can NOT conclude that there is a female predominance among those who suffer from FQ toxicity. While that may be the case, this information only indicates that there is a female predominance among our survey participants.

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AgePlease enter your age when you were floxed. (Enter your youngest age if floxed more than once)

Age (Years) Number (n=137)

%

16-20 7 5

21-30 26 19

31-40 31 23

41-50 40 29

51-60 23 17

61-70 6 4

>70 4 3

• This age distribution is not necessarily the age distribution of ALL victims of FQ toxicity. There may be a selection bias toward younger individuals who are more comfortable with the use of the internet and online forums. However, this does prove that FQ victims are not JUST the over-sixty population that is described on the FQ package inserts. This is clearly a problem for people of all ages.

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Ancestry

What is your ancestry?

Ancestry Number (n=137) Percent

European (Non-Hispanic)

116 85

Hispanic 4 3

African American 2 1

African 0 0

East Asian 4 3

Southeast Asian 0 0

Central Asian 0 0

South Asian 0 0

American Indian 1 1

Middle Eastern 0 0

Pacific Islander 0 0

Aboriginal Australian

0 0

Other 10 7

• This data should only be used as a reference point when interpreting the rest of the survey questions. Some participants noted that they did not easily fit into one of these categories. There is also some selection bias involved due to possible language barriers, access to computers, and many other factors.

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Baseline HealthDescribe your health before you were floxed.

Health Number (n=137)

Percent

Poor 0 0

Fair 4 3

Average 9 7

Good 42 31

Excellent 82 60

• It appears that most of the survey participants were in good or excellent health before exposure to a FQ. There again may be a bias toward healthier individuals because those who were in poor health before FQ exposure might not be able to easily identify new changes in their health or link those changes to the FQ.

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Baseline Activity LevelWhat was your level of activity before you were floxed.

Activity Number (n=137)

Percent

Athletic 36 26

Very Active 51 37

Average 40 29

Fair 9 7

Sedentary 1 1

• Most survey participants were very active before experiencing adverse events from a FQ. It is possible that active patients are more likely to be harmed after FQ exposure because they quickly resume their normal levels of activity. It is also possible that patients who are not active do not easily recognize FQ toxicity and attribute their symptoms to deconditioning.

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Baseline Medications

How many regular medications were you taking before you were floxed?Number of Medications

Number (n=137)

Percent

0 68 50

1 38 28

2 14 10

3 10 7

4 3 2

>4 4 3

• Just as most survey participants indicated they were in good health, most were also on very few, if any, medications prior to FQ exposure.

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Baseline BodyweightHow would you describe your body weight before being floxed?Weight Number

(n=137)Percent

Obese 2 1

Overweight 27 20

Average 94 69

Underweight 14 10

• Our results show a variety of baseline body weights. One theory that has been considered is that patients who are very thin are exposed to high doses of FQ and suffer as a result of high blood levels. Looking at this data, it appears that overweight and obese patients are also at risk of FQ toxicity.

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Personal History of Autoimmune Diseases

Did you have any autoimmune diseases before you took a FQ?Autoimmune disease

Number (n=137)

Percent

Yes, more than one

2 1

Yes, one 18 13

No 105 77

Possibly 8 6

Unsure 4 3

• The majority of participants did not have any autoimmune disease before FQ exposure. Fourteen percent of participants did have an autoimmune disease before FQ exposure. It would be interesting to compare that number with the rate of autoimmune diseases in the general population.

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Family History of Autoimmune DiseasesDoes anyone in your family have an autoimmune disease?Family History

Number (n=137)

Percent

Yes 20 15

No 101 74

Unsure 16 12

• While most participants didn’t have a family history of autoimmune diseases, 15% did have that family history. Again, this number would be interesting to compare to the rate in the general population.

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Typical Response to MedicationsHow would you describe your tolerance for other medications in the past?Medication Tolerance

Number (n=137)

Percent

I tolerate medications well 89 65I tend to have side effects 29 21I tend to have true allergic reactions 5 4I tend to have true allergic reactions and side effects 8 6I tend to have paradoxical responses (the opposite effect that was expected)

2 1

I have not taken any other medications 4 3

• Most participants tolerate medications well.

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Antibiotic Administered

Which antibiotic did you take?Antibiotic Number

(n=137)Percent

Levofloxacin (Levaquin)

47 35

Ciprofloxacin (Cipro)

55 40

Moxifloxacin (Avelox)

14 10

Multiple Fluoroquinolones

17 13

Other Fluoroquinolone

3 2

• While it is tempting to conclude that Cipro is the FQ with the most adverse events, we would first have to find out the frequency with which each one of the antibiotics is prescribed. It may be that Cipro is just the most commonly prescribed FQ.

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Response after First Exposure to FQWere you floxed on your first exposure to FQ’s?First Exposure Number

(n=136)Percent

Yes, my symptoms started after my first course with FQ’s

75 55

No, my symptoms started after my second (or greater) course of FQ’s

47 35

Unsure 14 10

• Thirty five percent of participants suffered from FQ toxicity on repeated exposure to the drugs. Evidently, it is not correct to assume that a person who has tolerated a FQ in the past will tolerate one in the future. It may be that these patients experienced a very mild reaction on first exposure that went unrecognized and then reactions were amplified on repeated exposure.

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Levofloxacin (Levaquin) DosePlease answer this question ONLY if you took Levaquin. If you took Levaquin, what dose did you take?

Levaquin Dose

Number (n=61)

Percent

250 mg 2 3

500 mg 35 57

750 mg 17 28

1000 mg 4 7

>1000 mg 3 5

• Levaquin toxicity occurred at a variety of doses. This data does not suggest that toxicity is dose-related. Although it would be interesting to compare doses to each patient’s body weight or FQ blood levels.

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Ciprofloxacin (Cipro) DosePlease answer this question ONLY if you took ciprofloxacin. If you took Ciprofloxacin, what dose did you take?

Ciprofloxacin Dose

Number (n=71)

Percent

250 mg 11 15

500 mg 44 62

750 mg 1 1

1000 mg 13 18

>1000 mg 2 3

• Cipro toxicity occurred at a variety of doses. This data does not suggest that toxicity is dose-related. Although it would be interesting to compare doses to each patient’s body weight or FQ blood levels.

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Moxifloxacin (Avelox) DosePlease answer this question ONLY if you took moxifloxacin (Avelox). If you took moxifloxacin, what dose did you take?

Avelox Dose Number (n=22)

Percent

<400 mg 1 5

400 mg 17 77

> 400 mg 4 18

• Avelox toxicity occurred at a variety of doses. This data does not suggest that toxicity is dose-related. Although it would be interesting to compare doses to each patient’s body weight or FQ blood levels.

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Duration of TreatmentFor everybody, how many days did you take the fluoroquinolone?Duration Number

(n=136)Percent

<5 Days 42 31

5-7 Days 34 25

8-10 Days 22 16

11-14 Days 11 8

>14 Days 27 20

• FQ toxicity occurred regardless of the duration of treatment. This data does not suggest that toxicity is related to the duration of treatment. Of the 42 people who took the FQ for less than 5 days, 36 (88%) stopped the FQ early as a result of side effects.

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Side Effects During TreatmentDid you notice any side effects DURING treatment?Side Effects Number

(n=136)Percent

Yes but I did not know what they were

59 43

Yes, I knew they were from the medication

51 38

No 21 15Don’t remember 4 3Unsure 1 1

• Most participants (81%) had side effects during treatment. Of the 51 patients who knew that the symptoms were from the FQ, 43 (84%) stopped the medication early.

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Early Cessation of FluoroquinolonePlease answer this question ONLY if you had a side effect during treatment. Did you stop the medication early because of side effects?

Medication Stopped

Number (n=116)

Percent

Yes 67 58

No 47 41

Don’t remember

2 2

• While 81% of participants had side effects during treatment, only 58% of participants stopped the FQ early due to side effects. Of the 67 patients who stopped the FQ early, 1% were warned about side effects by their physician, 4% were warned by their pharmacist, 46% read the drug information sheet with the prescription, and 28% said they knew about the side effects from ANY source when they started the medication.

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Prescribing DoctorWho prescribed the fluoroquinolone? (The first time you were floxed)Who Prescribed Number

(n=136)Percent

Primary care doctor 66 49Hospitalist 14 10ENT 17 13Urologist 11 8General Surgeon 4 3Orthopedic surgeon 0 0Physician Assistant or Nurse Practitioner

8 6

I received a FQ while under anesthesia

0 0

Other 16 12

• Most patients received FQ’s from their primary care doctors.

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Warnings from DoctorDid your doctor warn you about side effects?Doctor Warning

Number (n=136)

Percent

Yes 5 4

No 131 96

Can’t Remember

0 0

• Only 4% of participants were warned about side effects by their doctors.

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Warnings from PharmacistDid your pharmacist warn you about side effects?Pharmacist Warning

Number (n=136)

Percent

Yes 5 4

No 130 96

Can’t Remember

1 1

• Only 4% of participants were warned about side effects by their pharmacists.

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Reading the Drug Information SheetDid you read the side effects on the drug information sheet with your prescription?Drug Information Sheet

Number (n=136)

Percent

Yes 57 42No 38 28There was no drug information sheet to read

26 19

Can’t remember 15 11

• Forty two percent of participants read the information on the enclosed sheet with their prescriptions.

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Knowledge of Side EffectsDid you know about the side effects from ANY source when you took the medication?Knowledge of Side Effects

Number (n=136)

Percent

Yes 34 25

No 99 73

Can’t Remember

3 2

• While 42% of patients said they read the drug information sheet with their prescription, only 25% said that they knew about the side effects from any source when they started the medication. This either represents a misunderstanding of the survey questions OR it indicates that 17% of the patients who read the drug information sheet were not adequately informed by that sheet.

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Type of InfectionWhich type of infection did you have when you were prescribed the FQ?Infection Number

(n=136)Percent

Sinus 25 18Pneumonia 6 4Urinary tract/Prostate/Kidney 45 33GI Tract/Gallbladder 7 5Skin infection 4 3Other infection 19 14Prophylactic with a procedure (to prevent an infection)

1 1

It turns out I did not have a bacterial infection 29 21

• The most important piece of data here is that 21% of patients DID NOT have a bacterial infection.

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Fluoroquinolone as a First Line AgentWas a fluoroquinolone the first antibiotic tried?FQ First Number

(n=136)Percent

Yes, I got a FQ first

88 65

No, other antibiotics did not work

47 35

Don’t remember 1 1

• The majority of patients received a FQ as a first line agent.

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Steroid Administration During Treatment

Did you receive steroids with the FQ?Steroids Number

(n=136)Percent

Yes, oral or IV steroids

29 21

Yes, nasal steroids

10 7

No 94 69

Don’t remember 3 2

• While the majority of participants did not receive a steroid during treatment, an unacceptable number of patients did. It can be argued that the systemic absorption of nasal steroids is minimal, but the co-administration of oral or IV steroids should obviously be avoided as stated in the package insert. There are obviously specific situations where a steroid may be indicated but the risks and benefits of this decision need to be seriously considered.

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CulturesWere cultures of your infection site done to determine which antibiotic should be used?Cultures Number

(n=136)Percent

Yes, results were obtained

19 14

Yes, but results were not obtained

17 13

No 95 70Don’t remember/Not sure

5 4

• Seventy percent of patients did not have their infection site cultured and tested for antibiotic sensitivity.

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Timing of First SymptomsWhen did your first symptoms of toxicity appear?First Symptoms Number

(n=134)Percent

With first dose 22 16After first dose but during treatment course 59 44Within 1 week after treatment 21 16Between 1 week and 1 month after treatment 16 12Between 1 month and 3 months after treatment 11 8Between 3 months and 6 months after treatment 2 1Between 6 months and 9 months after treatment 1 1After 9 months after treatment 2 1

• Sixty percent of patients noted signs of toxicity during treatment with the FQ, 76% noted toxicity within 1 week after treatment, and 88% noted toxicity within 1 month of treatment.

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Symptom CyclesDo your symptoms seem to occur in cycles?Cycles Number

(n=134)Percent

Yes 86 64

No 35 26

Too early to tell

13 10

• Most patients have symptom cycles.

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Length of CyclesPlease answer ONLY if you have symptom cycles. How long do your cycles last?Length of Cycles

Number (n=91)

Percent

Days 10 11

Weeks 21 23

A few months

8 9

Many months

7 8

Years 6 7

Too early to tell

9 10

Variable 30 33

• There does not seem to be any pattern to the length of symptom cycles. There appears to be quite a bit of variability even among individuals.

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Exacerbating FactorsDo any of the following factors make your symptoms WORSE? (Check all that apply)Symptoms Worse

Number (n=134)

Percent

Cold weather 61 46

Humidity 24 18

Stress 84 63

Negative emotions

58 43

None 32 24

• Stress, cold weather, negative emotions appear to have affect a significant number of FQ sufferers.

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Symptoms Related to FoodsPlease check all that apply regarding foods and your symptoms.Symptoms/Food Number (n=134) Percent

I do not tolerate caffeine. 48 36

My symptoms are worse with soy.

30 22

My symptoms are worse with meats.

17 13

My symptoms are worse with seafood.

10 7

My symptoms are worse with sugar.

40 30

My symptoms are worse with dairy products.

16 12

Other 32 24

Food does not seem to affect my symptoms.

48 36

• About 1/3 of FQ sufferers do not notice any correlation between symptom severity and foods.

• Among the foods listed, caffeine, sugar, and soy were the most common symptom exacerbaters.

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Resolution of SymptomsAnswer ONLY if your symptoms resolved. How long after treatment did your symptoms resolve?Time to Resolve Number

(n=14)Percent

Less than 1 week 0 0

1 week to 1 month 0 0

1 month to 3 months 0 0

3 months to 6 months 2 14


1 year 2 14

1-2 years 4 29

2-3 years 3 21

3-4 years 0 0

> 4 years 2 14

• Fourteen of the 135 participants (10%) who answered this question reported a resolution of symptoms. This is likely a huge underrepresentation of the number of patients who recover because most patients who are feeling better are not going to continue to participate in the discussion forums or surveys.

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Duration of Continued SymptomsAnswer ONLY if you have continued symptoms. How long have you had symptoms so far?Symptom Duration Number

(n=121)Percent

Less than one week 0 0

1 week to 1 month 2 2

1 month to 3 months 6 5



9 months to 1 year 11 9

1-2 years 27 22

2-3 years 13 11

3-4 years 7 6

> 4 years 31 26

• For those patients who reported symptoms for > 4 years:– 16 reported 4-6 years– 5 reported 6-8 years– 4 reported 8-10 years – 2 reported >10 years (14 and

25 years).– (Some patients who

answered > 4 years did not report the total number of years)

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Progression of SymptomsComplete this statement regarding your symptoms. My symptoms seem to be:Symptom Progression

Number (n=134)

Percent

Getting worse 20 15

Staying the same 21 16

Slowly improving 60 45

Rapidly improving

1 1

Not getting better or worse but changing

32 24

• Most patients do report that their symptoms are slowly improving. However, a complete resolution of symptoms was not a choice for this question. Patients with resolved symptoms may have been forced to choose the “closest” answer which would skew our data.

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SymptomsMy symptoms include: (Check all that apply)

Symptom Number (n=134) Percent

Tinnitus 63 47

Hearing loss 22 16

Thoughts of suicide 45 34

Depression 78 58

Anxiety 77 57

Vision loss 52 39

Dry eyes 24 18

Retinal tears 5 4

Diplopia (Double vision) 18 13

Tendon rupture 16 12

Tendon pain 115 86

Muscle pain 106 79

Joint pain 114 85

Back pain 71 53

Fatigue 101 75

Neuropathic pain 85 63

Symptom Number (n= Percent

Paresthesias (Tingling) 81 60

Weakness 95 71

Weight loss 41 31

Muscle wasting 62 46

Headaches 58 43

New thyroid abnormalities

25 19

New endocrine abnormality other than thyroid

18 13

Memory loss 68 51

Insomnia 75 56

Muscle Twitching 79 59

Seizures 7 5

Abnormal heart rhythm

41 31

Popping/cracking joints

95 71

Hair loss 42 31

New dental problems 42 31

Other 44 33

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Worst SymptomThe symptom that causes me the most pain and/or disability is: (Choose one)


Paresthesias (Tingling) - -

Weakness 2 2

Weight loss - -

Muscle wasting 2 2

Headaches 1 1

New thyroid abnormalities

2 2

New endocrine abnormality other than thyroid

1 1

Memory loss - -

Insomnia 3 3

Muscle Twitching - -

Seizures - -

Abnormal heart rhythm

- -

Popping/cracking joints

1 1

Hair loss - -

New dental problems - -

Other 7 8


Tinnitus 2 2

Hearing loss - -

Thoughts of suicide 1 1

Depression - -

Anxiety 8 9

Vision loss - -

Dry eyes 1 1

Retinal tears - -

Diplopia (Double vision)

1 1

Tendon rupture 3 3

Tendon pain 26 29

Muscle pain 5 6

Joint pain 10 11

Back pain - -

Fatigue 2 2

Neuropathic pain 12 13

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Sites of Tendon PainPlease answer ONLY if you have tendon pain/ tendinitis. Where do you have pain? (Check all that apply)Tendon Pain Number (n=115) Percent

Biceps tendon(s) 36 31

Triceps tendon(s) 25 22

Deltoid tendon(s) 37 32

Pectoral Muscles/tendons

21 18

Elbow(s) 49 43

Wrist(s) 59 51

Fingers/thumb(s) 66 57

Groin 19 17

Hip(s) 64 56

Knee(s) 84 73

Front of lower leg (s) 36 31

Achilles Tendon(s) 82 71

Foot or toes 65 57

Back 45 39

Other 31 27

• The most common sites reported for tendon pain were the knees and achilles tendons.

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Sites of Neuropathic PainPlease answer ONLY if you have neuropathic pain. Where is your pain? (Check all that apply)

Neuropathic Pain

Number (n=85)

Percent

Face 27 32

Arms 35 41

Hands 41 48

Trunk 25 29

Sciatica 24 21

Lower legs 65 76

Feet 59 69

Other 14 16

• The most common sites of neuropathic pain reported were the lower legs and feet.

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Impact on Menstruation, Fertility, and Menopause

Please answer ONLY if you are female. (Check all that apply)Statement Number (n= 87) Percent

My symptoms vary with my menstrual cycle.

21 NA

Being floxed has changed my menstrual cycles.

16 NA

I have been pregnant since I was floxed. 3 NA

I was told to breastfeed while I was taking a FQ.

2 NA

I have had a miscarriage since I was floxed. 3 NA

I was given a FQ while I was pregnant. 0 NA

I am afraid to get pregnant (again). 12 NA

I have not been able to get pregnant (again).

1 NA

I have decided not to become pregnant (again) because of my health.

13 NA

I have new difficulty with estrogen replacement therapy since taking the FQ.

5 NA

• Percent values do not apply here because of the nature of the question. (For example, we do not know how many women are attempting HR therapy, so we can’t say how common it is to have new difficulty with it). Also, “none” was not an option so some of the 87 women who took the survey did not answer at all.

• However, there does appear to be some interplay between FQ toxicity and hormonal changes.

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MicrotearsDo you feel that you have been having “microtears” in muscles or tendons? (Small tears that feel like a “popping” sensation and cause pain afterwards but do not completely tear through the muscle or tendon)

Microtears Number (n=134)

Percent

Yes, this has been confirmed

14 10

Yes, but it has not been confirmed

60 45

No 23 17

Not sure 37 28

• Fifty five percent of participants have either had confirmed microtears or have felt presumed tears that have not been confirmed.

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Number of Tendon RupturesPlease answer ONLY if you had a tendon rupture. Did you have more than one tendon rupture?

Number of Ruptures

Number (n=14)

Percent

No, just 1 10 71

2 3 21

3 1 7

4 0 0

5 0 0

>5 0 0

• Most patients with tendon ruptures suffered from an isolated rupture. However, these individuals likely restricted their activities greatly after the initial tear to prevent another rupture. The fact that they did not have subsequent ruptures may reflect a lack of activity more than a lack of vulnerability to repeated injury.

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Timing of Tendon RupturesPlease answer ONLY if you had tendon rupture. How long after your treatment with the FQ did your (first) tendon rupture?Timing of Rupture Number (n=14) Percent

With first dose 0 0

After first dose but during treatment 3 21

Within 2 weeks of treatment 3 21

Within 1 month of treatment 3 21

1-3 months after treatment 1 7



9 months to 1 year after treatment 0 0

1-2 years after treatment 0 0

2-3 years after treatment 0 0

>3 years after treatment 0 0

• Most tendon ruptures were within a month of treatment (63%), but 28% were between 3 and 9 months after treatment.

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Signs of Impending Tendon RupturePlease answer ONLY if you have had a tendon rupture. In the time before your rupture, did you have pain or smaller tears or did the tear come out of nowhere?Warning before Rupture Number (n=14) Percent

Out of nowhere. No warnings beforehand.

8 57

Pain/tendinitis for some time before rupture

3 21

Sensation of smaller tears before the rupture

2 14

Other 1 7

• Warning signs before rupture varied. While most patients reported no warning signs (57%), 35% did note pain, tendinitis, or the sensation of smaller tears before the rupture.

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Number of Doctors ConsultedHow many doctors have you seen regarding these problems?Number of Doctors

Number (n=133)

Percent

None 4 3

1 7 5

2 11 8

3 15 11

4 15 11

5 29 22

At least 10 34 26

Too many to count

18 14

• The number of doctors consulted could be interpreted as a lack of helpful input from the medical community or as a measure of severity of illness.

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Any Doctor who Believes in FQ Toxicity

Have you found ANY doctor who believes that you have suffered adverse events from a FQ?Any Believing Doctor

Number (n=133)

Percent

Yes 85 64

No 28 21

Unsure 20 15

• Most participants have found A doctor who believes in FQ toxicity. However, a large proportion have not.

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% of Doctors who Believe in FQ Toxicity

Considering ALL of the doctors you have seen, what percentage do you think believes in FQ toxicity?

Percent of Believing Doctors

Number (n=133)

Percent

0% 29 22

5% 39 29

10% 17 13

25% 17 13

50% 18 14

75% 9 7

100% 4 3

• This is obviously a highly subjective question.

52

Diagnosis of FQ Toxicity

Who diagnosed you with FQ toxicity?Diagnosing Doctor Number (n=133) Percent

I diagnosed myself. 88 66

Primary care doctor 15 11

Neurologist 7 5

Rheumatologist 4 3

Dermatologist 0 0

Surgeon 0 0

Physical Medicine and Rehabilitation

4 3

Allergy and Immunology 1 1

Pain Specialist 0 0

Orthopedic Surgeon 1 1

Other 13 10

• Most patients diagnosed themselves with FQ toxicity.

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Doctors Found to be HelpfulWhat type of doctor have you found helpful?Helpful Doctor Number (n=133) Percent

None 60 45

Primary Care 14 11

Neurologist 11 8

Rheumatologist 8 6

Dermatologist 0 0

Surgeon 0 0

Physical medicine and rehabilitation

7 5

Allergy and Immunology 2 2

Pain specialist 2 2

Orthopedic surgeon 1 1

Other 28 21

• Most participants did not find any doctor to be helpful. Those who did find a helpful doctor most frequently reported that doctor to be in primary care. Some participants reported that multiple doctors were helpful but were unable to select that as an answer. There was also a large percentage who answered “other”.

54

Subsequent FQ PrescriptionsHas any doctor tried to give you another FQ after you told him/ her about your reaction?Subsequent FQ Prescription

Number (n=133)

Percent

Yes, he/she didn’t care or believe me

15 11

Yes, he/she did not know what a FQ was

6 5

No 109 82

Unsure 3 2

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Alternative Diagnoses ConsideredWhich of the following diagnoses have been considered during your workup? (Check all that apply)

Diagnosis Considered Number (n= 133) Percent

Lyme disease 46 35

Fibromyalgia 72 54

Chronic fatigue syndrome 40 30

Depression/Anxiety 68 51

Multiple sclerosis 35 26

Lupus 47 35

Rheumatoid arthritis 67 50

Hypochondriasis 22 17

Malingering 7 5

Hypothyroidism 34 26

Sjogren’s syndrome 21 16

Reiter’s syndrome 7 5

Raynauds 18 14

Polymyalgia rheumatica 10 8

Guillian Barre 8 6

Myasthenia gravis 8 6

Myositis 4 3

Amyotrophic lateral sclerosis (ALS) 7 5

Reflex sympathetic dystrophy (RSD) 9 7

Trigeminal neuralgia 4 3

Shingles 6 5

Other 55 41

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Abnormal Test ResultsHave any of the following tests been abnormal?Abnormal Test Number

(n=133)Percent

ANA (antinuclear antibody)

14 11

RF (rheumatoid factor) 8 6

CPK (creatine phosphokinase)

12 9

ESR (erythrocyte sedimentation rate)

9 7

Nerve conduction studies

19 14

None 91 68

57

Treatments UtilizedWhich treatments have you tried for pain or weakness? (Check all that apply)

Treatment Number (n=133) Percent

Stretching 83 62

Exercise 78 59

Herbal remedies 60 45

Vitamin supplements in general 97 73

Coenzyme Q 45 34

Magnesium 87 65

Nerve blocks/ injections 5 4

TENS unit (transcutaneous electrical nerve stimulator)

26 20

Steroids 21 16

Other 39 29

None 3 2

Treatment Number (n=133) Percent

Opioids (such as methadone, vicodin, oxycontin, etc)

33 25

NSAIDS (Advil, ibuprofen, aspirin, Celebrex, etc)

65 49

Tramadol 25 19

Neurontin or Lyrica 19 14

Antidepressants 32 24

Massage 56 42

Acupuncture 41 31

Physical Therapy 52 39

Heat 77 58

Ice 67 50

Topical menthols (Bengay, Tiger balm, etc.)

34 26

Topical NSAIDS (Voltaren gel, etc) 20 15

58

Helpful TreatmentsWhich treatments have helped you AT ALL? (Check all that apply)Treatment Number who found the

treatment helpfulNumber who tried the treatment

Percent


23 33 70


18 65 28

Tramadol 10 25 40

Neurontin or Lyrica 7 19 37

Antidepressants 12 32 37

Massage 39 56 70

Acupuncture 18 41 44

Physical Therapy 24 52 46

Heat 39 77 51

Ice 29 67 43


14 34 41

Topical NSAIDS (Voltaren gel, etc)

7 20 35

Treatment Number who found the treatment helpful

Number who tried the treatment

Percent

Stretching 49 83 59

Exercise 40 78 51

Herbal remedies 20 60 33

Vitamin supplements in general

38 97 39

Coenzyme Q 8 45 18

Magnesium 38 87 44

Nerve blocks/ injections

1 5 20


10 26 38

Steroids 2 21 10

Other 25 39 64

None 25 NA 19 (% of all 132 answers)

59

Most Helpful TreatmentWhich single treatment helped you the MOST? (Please check one)Treatment Number who

found treatment most helpful


Percent


13 33 39


6 65 9

Tramadol 4 25 16



Massage 6 56 16

Acupuncture 5 41 12


Heat 3 77 4

Ice 5 67 7


2 34 6


0 20 0

Treatment Number who found treatment most helpful


Percent

Stretching 2 83 2

Exercise 10 78 13



9 97 9

Coenzyme Q 0 45 0

Magnesium 11 87 13


1 5 20


0 26 0

Steroids 1 21 5

Other 15 39 38


60

Treatments that Worsened SymptomsWhich treatments made symptoms WORSE? (Choose all that apply)Treatment Number who

found treatment harmful


Percent


7 33 21


16 65 25

Tramadol 1 25 4



Massage 7 56 12

Acupuncture 4 41 10


Heat 6 77 8

Ice 6 67 9


2 34 6


2 20 10

Treatment Number who found treatment harmful

Number who tried treatment

Percent

Stretching 13 83 22

Exercise 33 78 42



5 97 5

Coenzyme Q 3 45 7

Magnesium 6 87 7


1 5 20


7 26 27

Steroids 14 21 67

Other 11 39 28


61

Surgery

Did you need to have surgery?Surgery Number

(n=132)Percent

Yes, for tendon rupture 5 4

Yes, for muscle injury 1 1

Yes, for eyes 0 0

Yes, for meniscus injury 2 2

Yes, for other musculoskeletal injury

4 3

Yes, for something other than musculoskeletal problem

10 8

No 110 83

Respondents who did require surgery: (may not be related to FQ in all cases)• Awaiting assessment of top of left femur bone - expecting it to

require surgery - cipro may(?) be involved? • Colon resection due to rupture, ruptured disc in neck, ankle

reconstruction due to ligament, cartilage etc. problems and break, hip surgery for torn labrum and other cartilage damage

• Gall bladder • Parathyroid and retinas • Torn meniscus but not sure if floxed before that but I think I had

been. Still trying to get records. • Sinus • Ovary removed due to large, complex cyst • Arthroscopy • I am still looking for a FQ Ortho • Muscle biopsy • Rib Surgery due to cartilage randomly breaking during cipro

treatment...other surgeries needed and I declined, such as a metal rod in my spine and so forth.

• Will need for shoulder torn tendons, not rupture • Not had it yet but recommended shoulder surg • Disc surgery x 4 • I will be having arthroscopic surgery on March 7, 2011 to repair

torn rotator cuff. • Tooth Extraction (#9) • Angioplasty • Kidney stone removal

62

Complications after SurgeryPlease answer ONLY if you had surgery for a tendon rupture. Did you have any complications after your surgery?

Complication Number (n=2) Percent

Yes, I had to get another operation

0 0

Yes, it took longer to heal than my doctor expected

0 0

Yes, it ruptured again 0 0

Yes, for any other reason

0 0

Not that I am aware of 2 100

• There were no apparent surgical complications for those who had tendon repairs.

63

Work and Living SituationPlease check all that apply regarding your work and living situation.

Work/Living Number (n=131) Percent

I have lost my job as a result of my health. 24 18

I can’t work at all because of my health. 46 35

I can only work part time because of my health.

25 19

I can’t support my family as a result of my health.

27 21

I have to use a cane or walker. 12 9

I have to use a wheelchair. 10 8

I can’t drive because of my health. 21 16

I can’t take care of myself. 21 16

I can’t carry groceries. 29 22

I can’t care for my child alone. 12 9

I don’t like to leave the house because of disability.

44 34

I need home health assistance (hygiene, meals on wheels, medications, blood draws, etc.)

3 2

None 45 34

64

Impact on RelationshipsPlease check all that apply regarding your relationships.Relationships Number

(n=131)Percent

My family doesn’t believe me. 11 8

My family doesn’t support me emotionally.

20 15

I am separated or divorced as a result of my health.

5 4

I have had my children taken away from me as a result of my health.

0 0

My relationship with my spouse is strained because of my health.

45 34

I have lost friends because of my health.

45 34

No one understands me. 42 32

I have decided not to have any more children as a result of my health.

14 11

None 46 35

65

Emotional/ Psychological ImpactPlease check all that apply regarding your emotional or psychological state.Emotional/Psychological Number

(n=131)Percent

I am depressed. 66 50

I am angry. 88 67

I am scared. 72 55

I have considered suicide. 46 35

I am taking medication for depression.

17 13

I am taking medication for anxiety.

18 14

I feel hopeless. 39 30

I am hopeful. 68 52

None 12 9

66

DisabilityPlease check all that apply regarding disability benefits.Disability Benefits Number

(n=131)Percent

I applied for disability but was denied.

15 11

I applied for disability and was accepted.

10 8

I did not apply for disability but I need it.

22 17

I do not need disability. 62 47

Other 25 19

• Most participants answered that they do not need disability. Nineteen percent applied for disability, but only 8% were accepted.

67

Legal ActionsPlease check all that apply about legal action.Legal action Number (n=131) Percent

I would like to sue but can’t afford it.

38 29

I would like to sue but don’t think I could win.

62 47

I would like to sue but I don’t have the emotional energy.

36 27

I am in the process of pursuing a lawsuit.

10 8

I tried to sue and won. 1 1

I tried to sue and lost. 2 2

I have sued/would like to sue my doctors.

26 20

I have sued/would like to sue the FDA.

43 33

I have sued/would like to sue the drug companies.

55 42

I don’t want to sue anyone. 18 14

Other 8 6

68

NomenclatureWhat should be the “official” name for what has happened to us?Name Number

(n=131)Percent

Floxed 9 7

Fluoroquinolone toxicity

55 42

Fluoroquinolone poisoning

44 34

Fluoroquinolone syndrome

14 11

Side effects 0 0

Adverse reactions

2 2

Other 7 5

Other names suggested

• 5-fluoroquinolone toxicity syndrome

• 1-Fluoroquinolone induced mitochondrial damage

• 1-fluoroquinolone antibiotic poisoning

• 1-fluoride toxicity• 1-Johnson and Johnson’s

disease

69

Future of Fluoroquinolones

Fluoroquinolones should:Future of Fluoroquinolones

Number (n=131)

Percent

No longer be available in the United States

13 10

Have additional labeling with clear warnings about real long-term effects

10 8

Be available only in life-threatening infections when all other alternatives have been exhausted

105 80

Not be regulated in any way

2 2

Other 1 1

• Most participants believe that FQ’s should not be banned altogether, but should be available only for life-threatening infections when all other alternatives have been exhausted.

70

Suggestions for Future Surveys• Patient height/ weight/ BMI compared to dosage• Patient socioeconomic status• Patient educational status• Do you believe you know anyone who has been floxed and does not know it or believe it?• Has anyone in your family taken a FQ and had an adverse reaction also?• Has anyone in your family taken a FQ and NOT had an adverse reaction?• If multiple FQ’s were used, did patient have adverse response to one but not the other?• Which side effects were noted during treatment?• Which side effect caused patient to stop antibiotic?• Doctors’ response when notified of adverse response.• Was your case reported to any agency?• If you heard or read about side effects before taking the medication, were the reactions downplayed?• In retrospect, do you feel that you needed a fluoroquinolone antibiotic?• If you stopped your treatment early and switched to another antibiotic, did the second antibiotic treat your infection adequately?• For those with culture results, were other antibiotics also an option?• For those with culture results, which organism (s) was idenetified?• How much time between symptom cycles?• Inquiry about additional food triggers, such as alcohol and aspartame.• Additional symptoms- ie skin, renal, immunologic manifestations• Specific questions about cognitive impairment• More specific questions for females only (menstruation, fertility, menopause, etc.)• More specific inquiry about treatment for specific symptoms, rather than as a whole• More specific information about those who had abnormal rheumatologic lab values.• Which types of exercise are tolerated/ not tolerated.• Financial cost of medical care from adverse reactions.• Financial cost in terms of lost wages.• Financial cost in terms of legal actions?

71

Disclosure

The author is suffering from fluoroquinolone toxicity and has been in regular email communication with survey participants, although none of the survey questions or results were discussed until after all data was gathered.

fluoroquinolone toxicity survey

Documents

diagnosis of fq toxicity

progression of symptoms

resolution of symptoms

duration of continued

online survey

magnitude of physical

fluoroquinolone antibiotics

baseline medications