Transcript Fluoroquinolone Toxicity Survey February 2011

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
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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 crosssection 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.
4
Gender
What 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.
5
Age
Please 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 oversixty population that is described
on the FQ package inserts. This is
clearly a problem for people of all
ages.
6
Ancestry
What is your ancestry?
Ancestry
Number (n=137)
Percent
European (NonHispanic)
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.
7
Baseline Health
Describe 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.
8
Baseline Activity Level
What 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.
9
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.
10
Baseline Bodyweight
How 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.
11
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.
12
Family History of Autoimmune
Diseases
Does 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.
13
Typical Response to Medications
How would you describe your tolerance for
other medications in the past?
Medication
Tolerance
Number
(n=137)
Percent
I tolerate medications well
89
65
I tend to have side effects
29
21
I tend to have true allergic
reactions
5
4
I tend to have true allergic
reactions and side effects
8
6
I 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.
14
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
17
Fluoroquinolones
13
Other
Fluoroquinolone
2
3
• 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.
15
Response after First Exposure to FQ
Were 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.
16
Levofloxacin (Levaquin) Dose
Please 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.
17
Ciprofloxacin (Cipro) Dose
Please 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.
18
Moxifloxacin (Avelox) Dose
Please 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.
19
Duration of Treatment
For 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.
20
Side Effects During Treatment
Did you notice any side effects
DURING treatment?
Side Effects
Number
(n=136)
Percent
Yes but I did not
59
know what they were
43
Yes, I knew they were
from the medication
51
38
No
21
15
Don’t remember
4
3
Unsure
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.
21
Early Cessation of Fluoroquinolone
Please 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.
22
Prescribing Doctor
Who prescribed the fluoroquinolone?
(The first time you were floxed)
Who Prescribed
Number
(n=136)
Percent
Primary care doctor
66
49
Hospitalist
14
10
ENT
17
13
Urologist
11
8
General Surgeon
4
3
Orthopedic surgeon
0
0
Physician 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.
23
Warnings from Doctor
Did 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.
24
Warnings from Pharmacist
Did 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.
25
Reading the Drug Information Sheet
Did you read the side effects on the drug
information sheet with your prescription?
Drug Information
Sheet
Number
(n=136)
Percent
Yes
57
42
No
38
28
There 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.
26
Knowledge of Side Effects
Did 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.
27
Type of Infection
Which type of infection did you have
when you were prescribed the FQ?
Infection
Number
(n=136)
Percent
Sinus
25
18
Pneumonia
6
4
Urinary
tract/Prostate/Kidney
45
33
GI Tract/Gallbladder
7
5
Skin infection
4
3
Other infection
19
14
Prophylactic 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.
28
Fluoroquinolone as a First Line Agent
Was 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.
29
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 coadministration 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.
30
Cultures
Were cultures of your infection site done to
determine which antibiotic should be used?
Cultures
Number Percent
(n=136)
Yes, results were
obtained
19
14
Yes, but results were
not obtained
17
13
No
95
70
Don’t remember/Not
sure
5
4
• Seventy percent of patients
did not have their infection
site cultured and tested for
antibiotic sensitivity.
31
Timing of First Symptoms
When did your first symptoms of
toxicity appear?
First Symptoms
Number
(n=134)
Percent
With first dose
22
16
After first dose but during
treatment course
59
44
Within 1 week after
treatment
21
16
Between 1 week and 1
month after treatment
16
12
Between 1 month and 3
months after treatment
11
8
Between 3 months and 6
months after treatment
2
1
Between 6 months and 9
months after treatment
1
1
After 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.
32
Symptom Cycles
Do 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.
33
Length of Cycles
Please 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.
34
Exacerbating Factors
Do 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.
35
Symptoms Related to Foods
Please 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.
36
Resolution of Symptoms
Answer 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
6 months to 9 months
1
7
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.
37
Duration of Continued Symptoms
Answer 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
3 months to 6 months
12
10
6 months to 9 months
12
10
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)
38
Progression of Symptoms
Complete 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.
39
Symptoms
My symptoms include: (Check all
that apply)
Symptom
Number (n=
Percent
Paresthesias (Tingling)
81
60
Weakness
95
71
Weight loss
41
31
Symptom
Number (n=134)
Percent
Tinnitus
63
47
Muscle wasting
62
46
Hearing loss
22
16
Headaches
58
43
Thoughts of suicide
45
34
25
19
Depression
78
58
New thyroid
abnormalities
Anxiety
77
57
18
13
Vision loss
52
39
New endocrine
abnormality other
than thyroid
Dry eyes
24
18
Memory loss
68
51
Retinal tears
5
4
Insomnia
75
56
Diplopia (Double vision)
18
13
Muscle Twitching
79
59
Tendon rupture
16
12
Seizures
7
5
Tendon pain
115
86
Abnormal heart
rhythm
41
31
Muscle pain
106
79
95
71
Joint pain
114
85
Popping/cracking
joints
Back pain
71
53
Hair loss
42
31
Fatigue
101
75
New dental problems
42
31
Neuropathic pain
85
63
Other
44
33
40
Worst Symptom
The symptom that causes me the most
pain and/or disability is: (Choose one)
Symptom
Number (n=90)
Percent
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
Symptom
Number (n=90)
Percent
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
41
Sites of Tendon Pain
Please 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.
42
Sites of Neuropathic Pain
Please 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.
43
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.
44
Microtears
Do 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.
45
Number of Tendon Ruptures
Please 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.
46
Timing of Tendon Ruptures
Please 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
3-6 months after treatment
2
14
6-9 months after treatment
2
14
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.
47
Signs of Impending Tendon Rupture
Please 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.
48
Number of Doctors Consulted
How 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.
49
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.
50
% 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.
51
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.
52
Doctors Found to be Helpful
What 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”.
53
Subsequent FQ Prescriptions
Has 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
54
Alternative Diagnoses Considered
Which 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
55
Abnormal Test Results
Have 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
56
Treatments Utilized
Which treatments have you tried for pain
or weakness? (Check all that apply)
Treatment
Number (n=133)
Percent
Treatment
Number (n=133)
Percent
Opioids (such as methadone, vicodin,
oxycontin, etc)
33
25
Stretching
83
62
NSAIDS (Advil, ibuprofen, aspirin,
Celebrex, etc)
65
49
Exercise
78
59
Tramadol
25
19
Herbal remedies
60
45
Neurontin or Lyrica
19
14
Vitamin supplements in general
97
73
Antidepressants
32
24
Coenzyme Q
45
34
Massage
56
42
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
Acupuncture
Physical Therapy
41
52
31
39
Heat
77
58
Ice
67
50
Topical menthols (Bengay, Tiger
balm, etc.)
34
26
Topical NSAIDS (Voltaren gel, etc)
20
15
57
Helpful Treatments
Which treatments have helped you
AT ALL? (Check all that apply)
Treatment
Number who found the
treatment helpful
Number who tried
the treatment
Percent
Treatment
Number who found the
treatment helpful
Number who tried
the treatment
Percent
Stretching
49
83
59
Opioids (such as
methadone,
vicodin, oxycontin,
etc)
23
33
70
Exercise
40
78
51
Herbal remedies
20
60
33
NSAIDS (Advil,
ibuprofen, aspirin,
Celebrex, etc)
18
38
97
39
Tramadol
10
Vitamin
supplements in
general
Coenzyme Q
8
45
18
Magnesium
38
87
44
65
25
28
40
Neurontin or Lyrica
7
19
37
Antidepressants
12
32
37
Massage
39
56
70
Nerve blocks/
injections
1
5
20
Acupuncture
18
41
44
10
26
38
Physical Therapy
24
52
46
TENS unit
(transcutaneous
electrical nerve
stimulator)
Heat
39
77
51
Steroids
2
21
10
Ice
29
67
43
Other
25
39
64
Topical menthols
(Bengay, Tiger
balm, etc.)
14
34
41
None
25
NA
19 (% of all
132 answers)
Topical NSAIDS
(Voltaren gel, etc)
7
20
35
58
Most Helpful Treatment
Which single treatment helped you
the MOST? (Please check one)
Treatment
Number who found
treatment most
helpful
Number who tried
the treatment
Percent
Stretching
2
83
2
Exercise
10
78
13
9
Herbal remedies
2
60
3
97
9
16
Vitamin
supplements in
general
9
25
3
19
16
Coenzyme Q
0
45
0
Antidepressants
1
32
3
Magnesium
11
87
13
Massage
6
56
16
Acupuncture
5
41
12
Nerve blocks/
injections
1
5
20
Physical Therapy
6
52
11
0
26
0
Heat
3
77
4
TENS unit
(transcutaneous
electrical nerve
stimulator)
Ice
5
67
7
Steroids
1
21
5
Topical menthols
(Bengay, Tiger
balm, etc.)
2
34
6
Other
15
39
38
Topical NSAIDS
(Voltaren gel, etc)
0
None
27
NA
20 (% of all 132
answers)
Treatment
Number who found
treatment most
helpful
Number who tried
the treatment
Percent
Opioids (such as
methadone,
vicodin, oxycontin,
etc)
13
33
39
NSAIDS (Advil,
ibuprofen, aspirin,
Celebrex, etc)
6
65
Tramadol
4
Neurontin or Lyrica
20
0
59
Treatments that Worsened Symptoms
Which treatments made symptoms
WORSE? (Choose all that apply)
Treatment
Number who found
treatment harmful
Number who tried
the treatment
Percent
Treatment
Number who found
treatment harmful
Number who
tried treatment
Percent
Opioids (such as
methadone,
vicodin, oxycontin,
etc)
7
33
21
Stretching
13
83
22
Exercise
33
78
42
NSAIDS (Advil,
ibuprofen, aspirin,
Celebrex, etc)
16
Herbal remedies
8
60
13
Tramadol
1
25
4
5
97
5
Neurontin or Lyrica
4
19
21
Vitamin
supplements in
general
Coenzyme Q
3
45
7
Antidepressants
10
32
31
Massage
7
56
12
Magnesium
6
87
7
Acupuncture
4
41
10
Nerve blocks/
injections
1
5
20
Physical Therapy
19
52
37
7
26
27
Heat
6
77
8
TENS unit
(transcutaneous
electrical nerve
stimulator)
Ice
6
67
9
Steroids
14
21
67
Topical menthols
(Bengay, Tiger
balm, etc.)
2
34
6
Other
11
39
28
Topical NSAIDS
(Voltaren gel, etc)
2
20
10
None
45
NA
34 (% of all 132
answers)
65
25
60
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
No
110
Respondents who did require surgery: (may not be
related to FQ in all cases)
•
•
•
•
•
•
•
•
•
•
•
8
•
•
•
•
83
•
•
•
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
61
Complications after Surgery
Please 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.
62
Work and Living Situation
Please 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
63
Impact on Relationships
Please 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
64
Emotional/ Psychological Impact
Please 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
65
Disability
Please 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.
66
Legal Actions
Please 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
67
Nomenclature
What 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
68
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 lifethreatening 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.
69
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?
70
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.
71