Post Marketing Reports for June 2000

Doc 11
2161From: ejborovatz@f...
Date: Thu Jun 1, 2000 6:48am
Subject: Levaquin--FDA Reporting of ADR's

About three weeks after I was FQ'd, I posted my ADR with the drug
company(Ortho McNeil) and the FDA. I also asked if there were any
other reports of peripheral neuropathies with Levaquin and they said
none have been reported. The other day my neuro told me that she had
researched all ADR reports for Levaquin internationally and did not
find any. She has thus, through a process of elimination, determined
that I have had a Guillain Barre type reaction. What I don't
understand is that if ADR's have been occuring for a few years, why
are they not reported? I really feel that my neuropathies are a
direct result of Levaquin and that others have had the same problems,
but the drug companies won't address it unless all cases are
reported. I'm just really confused about why my case is the only one
reported.



Doc 13
2163From: Connie <ctraylor@a...>
Date: Thu Jun 1, 2000 2:47pm
Subject: Reporting to FDA and Ortho McNeil

I reported my ADR to Levaquin to the FDA and to Ortho McNeil. Both
sent back letters that they were sorry to learn of my problem and
Ortho McNeil even offered to repay me for the Levaquin that I had not
taken. If Ortho and the FDA say they have no reports they are
outright lying.

Doc 12

2162From: No1DOSMOM@a...
Date: Thu Jun 1, 2000 3:12am
Subject: Re: Levaquin--FDA Reporting of ADR's

My 16 year old daughter was FQ'd by Levaquin. I have filed two reports with
the FDA. Whoever told you there has been no reporting is lying through their
teeth. I can positively state this because I have the worthless "thank you
for reporting" letters from Med Watch.

~Pat

Doc 25
2200From: MBILLIK@p...
Date: Wed Jun 21, 2000 10:18am
Subject: Update on the other Mel (Barry -- note)

Hi folks.

I took levaquin in March for a sinus infection. Got severe shoulder
problems after that.

Finally ended up seeing an orthopedic surgeon. While I thought it was
a torn rotator cuff, he says while that MIGHT be the case, he thinks
it is adhesive encapsulitis (frozen shoulder). This could have
resulted from that.

Anyway, I am currently being more aggressive with P/T. Progress is
very slow, but there is a bit.

Meanwhile, Barry, I did call the attorney. He is only interested in
pursuing this if I have to undergo surgery (which is a distinct
possibility if the P/T doesn't do it). But that might be worth noting
for others.

Mel




Doc 24
2195From: Rick Tyler <rick@r...>
Date: Mon Jun 19, 2000 9:07am
Subject: Re: reaction to Levaquin

You asked if anyone else had had the same symptoms as you. The
answer is yes, and some of us have had all of them. Personally, I
had parasthesia (numbness and tingling) on the left side of my face,
parasthesia in my fingers, severe long-lasting pain (felt like
cramps)in both calves, joint pain in knees, elbows, and wrists, and I
was tired all the time. Aside from your tremors, we could almost be
twins. (I also got depression, vision problems, and rotator cuff
tendinitis.)

You didn't say if your symptoms have changed over time. It's been a
little over a year for me, and I have definitely improved. How about
you?

-- Rick



Doc 23
2191From: nfstrauss@y...
Date: Fri Jun 16, 2000 5:19pm
Subject: reaction to Levaquin

I took Levaquin for a prostrate infection over 1 year ago. The first
time I took it, no reaction. The second time I took Levaquin, I had a
reaction after two pills. The right side of my face got numb. It is
now over 1 years after taking Levaquin and I am still having side
effects.I have tingling and numbness in both hands and feet. I get
cramps in my legs. Now I have pain in both wrists and I am unable to
lift heavy objects. At night when I first go to sleep, I have tremors
lasting over one hour according to my wife. I am contstantly tired
and have constant muscle and joint pain. I have been to see a general
doctor and a Neurologist. They ran an MRI of the brain and neck,and a
EMG. The results are normal. My doctor ran a blood test for the
smooth muscles. The results show that the count is elevated, but
their is no imflamation of the muscles. The doctor does not know why.
Now they want to do a muscle biopsy to check the muscles. Has anyone
had similiar symptoms? I live in the Chicago area. Does anyone know
of doctors in this area that have treated patients with similiar side
effects from Levaquin?


Doc 22
2189From: jbrigant@o...
Date: Thu Jun 15, 2000 9:12pm
Subject: FDA

I recieved a call from a Harold Davis from the FDA. He said he was
responding to my letter to MedWatch. He was very frank & admitted
that FQs are the cause of my (our) physical problems. When I asked
him why I got such preferential treatment when everyone else I'm in
communication with has gotten the brush off, he said, "their letters
didn't get to me."

So.Send your testimonies to: Harold Davis
FDA
HFD210
5600 Fishers Lane
Rockville, Maryland 20857
He also said that you don't need a drs testimoney linking our ills to
FQs but I should get a list of all victims reported to Medwatch by
writing: HFI-35
FDA
5600 Fishers Lane
Rockford, Mayland 20857

He also said we should write for the ADR printout on FQs & ask for a
certified copy of the Levaquin labling on my (your) date of taking
FQs. It's late & I'm hurting bad & can't sleep so I forget what he
said about where to get this. I need to call him again, but here's
his phone # - 301-827-3468.

The last thing he said was if you want to sue, don't go class action,
go individually.

Maybe a breakthrough? Judy


Doc 21

2181From: No1DOSMOM@a...
Date: Sun Jun 11, 2000 2:13pm
Subject: Re: A three month regimen of Floxin for unverified UTI?

Your pharmacists deserves a medal. The dumb moron who filled Cheri's RX
didn't even alert me about a pediatric warning and there was no pediatric
warning on the sheet he gave me. Believe me, had there been a warning I
would have NEVER given it to Cheri.

Regards,

~Pat


Doc 18
2177From: rjwallac@g...
Date: Thu Jun 8, 2000 8:27pm
Subject: When get better?

I stopped taking cipro eye drops 3 weeks ago, and then strange
symptoms started - tingling, pricklies, numbness and hypersensitivity
to first my r foot, then r hand, etc until both feet and calves and
both hands. Then 5 days ago, strange itchy, burny palms that lasted
2 days. And then yesterday I noticed my r hand/wrist didn't feel
right, and now the weakness/heaviness/stiffness is in all my
extremities, and possibly my jaw (or it may be stress!!!!!)

My dr did suggest quinolones as the possible culprit, but not too
likely. After reading this forum, however, I'm convinced. (My next
appt is tomorrow.)

Meanwhile, I bought calcium/magnesium supp and bottled water today.
And no more chicken for a while! Does anyone have any additional
suggestions? I know my symptoms are not nearly as severe as many of
you, but since they get significantly worse every day, even after
over 3 weeks off meds, I'm wondering if there is a consensus on a
"peak" time, after which symptoms at least will level off. Do I need
to exercise and stretch every hour or two to keep the flexibility in
my joints? Please help!

Thanks in advance -- Julie


Doc 17
2174From: Rick Tyler <rick@r...>
Date: Tue Jun 6, 2000 3:43pm
Subject: My First Anniversary, part 1

This week marks the first anniversary of my being FQd. During the
first week of June, 1999, I took 3 Levaquin (I believe 500mg each)
and one Cipro. I've gone back over my posts to the Quinolone group
and listed all the symptoms that I've mentioned over the past year,
and then provided a current status. This may be of interest only to
me, but it might provide some longitudinal insight to one case of ADR
to FQs.

1. Rotator cuff tendinitis (doctor diagnosed), arm parasthesias,
ulnar nerve problems, hypersensitive skin, and index finger stiffness.

The tendinitis appeared early on, in the first month, and lingered
for a long time. Even today, my left shoulder is a little stiff.
The tingling and pain in my fingers lasted for months, then slowly
faded.

The hypersensitivity was an occasional effect that disappeared fairly
soon -- perhaps by September. The sore index finger still comes and
goes.

The ulnar nerve problems appeared at about six months, and gradually
improved. The sensation in my left little finger is somewhat
reduced, and I am prone to some pain in the outside edge of my left
elbow. This does not seem to be getting worse or better. My right
arm is now completely normal, with no symptoms of either tendinitis
or ulnar nerve problems.

2. Depression

I am a southern California boy (of 43) who moved to Redmond, a suburb
of Seattle, in November, 1997. The winter of 1998-99 was the darkest
and rainiest in the area's history. Natives were complaining of
seasonal depression and threatening to move. In the winter of 1999 I
suffered from a period of anxiety (which I had never before
experienced) and minor panic attacks. By the time of the FQ incident
in June I had been free of anxiety symptoms for a month or so (the
sun came out). I mention this because anxiety and depression
frequently go together and I cannot be sure that what happened in
June and July were necessarily a result of the FQ. (Having said
that, I am personally absolutely convinced that my ensuing bout of
depression was COMPLETELY triggered by the FQs.)

Starting in mid-June, about 2 weeks after being FQ'd, I started
having classic symptoms of severe depression: I was weepy, had
trouble staying asleep, was laying awake in the dark, had trouble
caring about anything, lost 15 pounds (not a bad thing, in my case),
and lost interest in life. This lasted about six weeks and resolved
itself. I took Zoloft briefly -- it made me an insomniac -- and took
SAM-e for about 4 months. I have had no recurrence of either anxiety
or depression since.

3. Leg pain, joint pain, muscle twitching (fasciculations)

Aside from the depression, this was the worst effect of the FQs. The
pain in my calves was unrelenting and lasted for about six months. I
had joint pains for nearly that long. At times I felt like a zombie,
with nothing moving right, and everything sore. The pain is now
gone, and my legs seem fine.

The fasiculations in my legs were likewise unrelenting, and went on
for at least 8 months. I thought that it would never get better.
The twitching mostly stopped 2-3 months ago, although I now get
twitching muscles almost every time I do even mild leg exercising
(like brisk walking or bicycle riding).

4. Visual field distortions, eye problems

This is an example of a probable ADR that may or may not have been
caused by the FQs. I felt mild irritation in my left eye that went
on for months. I also had shimmering in my field of vision that was
worse under fluorescent lights and in sunlight. I had two separate
bouts of extreme light sensitivity -- one in June and July, 1999, and
again for a shorter period in December 1999. An ophthalmologist and
an optometrist examined me and found nothing.

In January, 2000, I visited another ophthalmologist who discovered
that I had a plugged duct in my eyelid. After clearing the plug -- a
not altogether pleasant experience -- my eye felt less irritated.
The irritation has not recurred, and the clog seems to have been the
cause. Perhaps inflammation from the FQs contributed to the clog,
but it seems inconclusive. It's hard to believe it was a coincidence,
but it is also hard to believe the FQs were the direct cause. He
diagnosed the shimmering and light sensitivity as migraine auras. I
have never had migraine problems, and have never had a migraine
headache. This might not be an ADR, but it did happen right after
the FQ episode. Anyone else have FQ-related migraines? Unlike some
other people, my visual acuity was unaffected.

5. Tinnitus (ringing in the ears)

This bothered me a lot during the same period I was suffering from
vision problems. I assume they were related. I recently noticed
that I hadn't had tinnitus for a long time. I cannot say when it
stopped.

6. Foggy brain, slow thought, "disconnected" feeling

This lasted longer than the depression, which was pretty much gone by
mid-August. I can't really say when it went away, but it seems to
have just slowly gotten better. I would say that I have been
mentally back up to nearly 100% (I am, after all, over 40 and not
nearly as quick as my 11- and 8-year-old sons!) for about three
months.

7. Chicken

Eating chicken caused *frequent* relapses until someone here
mentioned the linkage between poultry and FQs. Someone else (you
people are great) suggested taking calcium with poultry and, voila!,
no more problems, although I rarely eat poultry anymore. I keep Tums
everywhere I eat and I can now eat chicken without getting FQ'd. The
calcium trick sure worked for me.

8. Neck pain

This was a separate, and really nasty, source of pain, that started
in June and lasted for months. Some days it was debilitating, but
most of the time it wasn't as bad as the leg pain. It's gone now,
but it is my first sign of a relapse. (You know about the relapses,
right? They are mini-versions of the first FQ attack. Mine usually
last from 3-7 days, and at least some of them seem to have been
triggered by eating chicken.)

This group has been a source of information and never-ending support.
Thanks to all of you.

-- Rick



Doc 16
2173From: Shupe, Gerald K. DOC <Gerald.Shupe@d...>
Date: Tue Jun 6, 2000 2:13pm
Subject: levaquin

I am a 39 yo male. I was prescribed levaquin twice (1 dose/day for 30
days)for prostate infections. The first time it worked very well with no
side effects. However, the second time I had serious problems. By the fifth
day I ached in most joints. My heels hurt so bad I could hardly walk and my
hands hurt so bad I couldn't easily hold a plastic cup. I also felt pressure
and pain in my chest, and walking up a flight of steps caused such severe
pain that I thought might be having a heart attack. I suspected it might be
the levaquin so I checked the internet and found many similar stories. I
stopped taking the drug and within five days the chest pain eased up, but it
is 3 months later and the apparent arthritis remains in my heels, hands and
knees. My doctor just shrugged and switched me to tetracycline.

Jerry Shupe


Doc 15
2167From: cpeters701@a...
Date: Thu Jun 1, 2000 4:21pm
Subject: Re:

I just wanted to say I know for a fact I was affected by these antibiotics 7
months ago. I am finally doing better, after hallucinations, panic attacks,
gastrointestinal problems, inflamation problems, it was horrifying in the
beginning. I am doing good now, just wanted to let others who are suffering,
you will get through this it takes some time, I still have pain in my right
sholder and left knee. Might be from something else but I have a feeling I
know what it is from. I have a doc who believes it was from antibiotic,
which is rare. Ive been to many docs who just skip by the ADR part, I know
what your all going through, anyone in need of support, please write, take
care Penny


Doc 14
2166From: claude brigante <jbrigant@o...>
Date: Thu Jun 1, 2000 6:24pm
Subject: Re: Re: Levaquin caused Gastroparesis

After being FQ'd in March, 99' , first symptom was sudden severe then
chronic pain in both knees, shin bones & leg muscles. I started with severe
stomach pain about a 2-3 months later. Turned out to be an ulcer, never had
stomach problems before. Then, several months later, developed severe
gastritis, weight loss, diarrhea, all new to me. Now, drs tell me I'm
anemic. Present tests so far show no internal bleeding. Ulcer pain &
gastritis pain are cyclical, (as are all my symptoms), with periods of
"normalcy". What exactly is gastropariesis?

Only 4 months ago, I developed severe tenndonitis in right ring finger, dr
called it "trigger finger" very painful & debilitating. Took a chance &
allowed a cortisone shot & now am pain free, finger moves normally except
sometimes the finger joint "snaps" again & can't open & close fluidly.
Still, I'm grateful. Judy

Doc 33
2231From: swoz107c@a...
Date: Thu Jun 29, 2000 3:02am
Subject: Re: Parasthesia Sufferers

I took Avelox (2 pills) and both nights woke up with tingling arms.
I thought it was due to the fact that I had been so sick and had been
laying down a lot. Now I know it is a symptom from my ADR. My
doctors put me on prednisone to clear the infiltrates from my lungs
and the tingling went away. Do you have joint pain in your toes and
hands? Just wanted to let you know so you don't worry about MS.
Every once in a while I have tremors in my hands and can't stop
shanking. Was completely normal before!!! Sue



Doc 32
2227From: mia979@y...
Date: Wed Jun 28, 2000 1:17pm
Subject: Levaquin and Depression?????

Has anyone experienced an ADR to Levaquin in the form of severe
depression? A young relative recently took his own life after being
on Levaquin for 3 weeks...which was COMPLETELY out of character for
him. He had been showing signs of depression for a few weeks but was
happily married and had young children. It was a shock to his family
and his many friends since he loved life and his family. Thanks for
any information.

Doc 31
2226From: coa132435@y...
Date: Wed Jun 28, 2000 3:49pm
Subject: Can Levaquin cause this???

After a night with fever (104 F) I went to Emergency for diagnosis
and medicine. After some test the Doctor told me I had Pneumonia, I
disagreed with the diagnosis but I did not have option but to follow
the recommendations and take my prescription. I was also given
Tylenol and I kept taking Tylenol every 6 Hours and Levaquin was
given once a day.

After one Levaquin (500 mg)(The day after) my urine turned dark like
the same color like ice tea (The doctor never told something about)
then I decided to go with my PCP, he based on the initial diagnosis
and confirimed the treatment and dosis Levaquin 500 mg once a day
plus also told me to continue with Tylenol and also add Motrin due
the Fever was still high (103) leaving 2 hours between Tylenol and
Motrin. I mentioned the change on the color of my urine but I was
told "Normal reaction because of Levaquin". The day after (2 days
taking Levaquin and one day combining Tylenol and Motrin) I woke up
and loot at my self in the mirror. The color of my skin and eyes
(white part of my eyes) were Yellow yes color Yellow. I called my PCP
again asking if it was a normal reaction. He asked me to go to his
office. He saw me and asked me to stop everything and change the
antibiotic and ask to stop tylenol. He took some blood work again and
all parameters realted with my liver were really high (some values
were up to 5 times the highest value of the normal range) he also
told me that I did not improve in the next 24 hours I should go to
the hospital also all test showed NO HEPATITIS neither A,B nor C.

At this point I decided to stop everything by myself taking the
risk, I did not take the new antibiotic (Azythromi something) and I
as just drinking water and everything began to improve finally 4 day
after the color of my skin, eyes and urine returned to normal. The
last blood work showed all liver parameters close to normal.


My Age 30, No Alcohol, No Liver Damage before this. General Speaking
on good health condition until this which has been the most serious
threating to my health.

Does anybody know or have heard Levaquin could affect so serious
the liver? I have always used Tylenol since I was 14 and this is the
first time this happened to me.

Any comment is really appreciated.

Sorry for my English I am still working on it.



Doc 29
2209From: Beadit42@a...
Date: Mon Jun 26, 2000 0:26pm
Subject: Re: Parasthesia Sufferers

Funny that I should read your letter about the neurologist,because I just
came home from seeing one and he said the same thing to me re: carpel tunnel
in my left hand. I painted ceramics for several years and also didn't have
any problems until I took Floxin three years ago!! Sorry to say this but it
is three years for me and I am still really sick and all the doctors say the
same thing. They even get "scared" when you mention the ADRs to them.
Good luck
Sherry
P.S. My son (23 years old at the time) last August was given Levaquin and is
still really sick too. Most of the doctors do say, if have an ADR to this
drug, don't let anyone from your family(blood relative, children) take them.
Why do you think they say that when they won't admit that it is a problem?

Doc 28
2208From: pdunn@t...
Date: Mon Jun 26, 2000 1:35pm
Subject: Parasthesia Sufferers

I took Levaquin in April and immediately suffered parasthesias in
both arms the night I took my first dose. Although I called the Dr.
the next day, I was told that it was not from the Levaquin and
continued taking the entire course of the drug (10 days). During
those 10 days, the numbness and tingling got worse. It got to the
point where I was extremely paranoid that I had some horrible
neurological ailment (specifically, my biggest fear was MS).

I went to a neurologist who diagnosed me with carpal tunnel syndrome
(I've played the guitar for 14 years and he felt that it was a
repetitive motion injury). He acknowledged that quinolones could
cause parasthesias, but I later found out in a letter that he wrote
to my GP that he felt the Levaquin was a coincindence. It seemed
strange to me that I was diagnosed with carapal tunnel since I have
not had any problems like that before and my wrists didn't even
hurt. Even more puzzling was the fact that carpal tunnel only
effects your thumb and first two fingers, and my entire hand was
falling asleep (literally paralyzed) while I tried to sleep each
night.

Anyway, for the next few weeks, I began to quit worrying, and it
seemed to be getting better. However, this past week, I have had
more parasthesias and I am now experiencing some mild numbness on the
top of my feet between my big toe and second toe. This new bout has
put me into another worrying phase where I fear that I have MS or
some other neurologocal disease. However, I realize that many other
quinolone sufferers have the same problems, so Levaquin is the most
likely culprit. I just pray that this doesn't get worse and
eventually heals. I can't believe that 10 stupid little pills can
affect a persons life so much. It has changed my personality and
hurt my productivity at work. Although I have always worried about
my health, this stuff has put me over the top.

I have also noticed that my nerves seem to be more sensative now. I
have banged my hand a couple of times since taking Levaquin and
gotten "Pins and Needles" sensations. That never used to happen,
except for the occassional banging of the funny bone. To me, it
seems like Levaquin has caused some sort of nerve damage (hopefully
not permanent).

What has happened to those of you who have suffered these types of
parasthesias? Have they gotten better or worse? Or have they been
like mine, where you think they are better and then all of a sudden
show up again? Have they spread? Mine started in my hands and arms
but now seem to be in my feet too. It hasn't seemed to effect my
motor skills at all, thankfully, but I worry that it might. I took
the last Levaquin on April 19th, and from what I've read on this
forum, I'll probably have to deal with this stuff for a while.

Meanwhile, I'm going to have a follow-up with the neurologist in
August and I'll be a little more firm about my suspiscion that
Levaquin created this condition. It probably won't help any, but I'm
tired of doctors discounting that explanation. Maybe if they looked
into it more instead of doubting it, we could get some help.

Good luck to all of you!


Doc 27
2203From: ed41560@a...
Date: Fri Jun 23, 2000 7:27am
Subject: Re: Confused? Levaquin

I've had what I think is a reaction to Levaquin. My symptoms where PN
related. I posted my story several times over the past year. I did not pursue
action because I was never sure my issues where related to Levaquin. I know I
didn't have them before I took it.

Anyway I'm 85-90% better. So may some others as well. How do we really know
it was the Levaquin without taking it again?

Any ideas, I would be willing to help.



Doc 26
2199From: Lona <kikipuppy@m...>
Date: Tue Jun 20, 2000 6:48pm
Subject: Re: Re: reaction to Levaquin

Hi ,
I just signed on here the other day. I was given Levaquin for a sinus and
ear infection that was not going away after thwo rounds of biaxin. I got
symtoms of hypermania and insomonia and headache. In the past I have taken
Cipro without any problems. They switched me to Cipro and the symtoms
seems to diminsh but were still there. Today I went in to the Dr. and saw
a PA. She took down all the info, talked to the Dr. and he wanted me to
stay on Cipro telling her the Levaquin was problably still in my system and
would most likely abate. I have searched the web and read what quinelones
can do. I told her I would go without or find another doctor. I need help
with my infection. She finally gave me augmention if I would promise to
see a doctor on Monday. Why would a doctor leave me on this? Why, when I
presented with symptoms would they not take me off? If anyone knows of a
good way to boost the immune system, that does not affect the adrenals or
pancreas, please let me know.
Lona