Post Marketing Reports for October 1999

Doc 178
610From: marketp@z...
Date: Fri Oct 8, 1999 4:56am
Subject: Is there any way to diagnos FQ-induced panic?

My Levaquin nightmare started over two months ago. However, only last
week did I start to re-experience restlessness, heart pounding, a
feeling that my arms are shaking, even when they're not, funny tremors
-- a lot like anxiety, except there's nothing in particular on my mind.

I know some folks have had this effect from the Levaquin. However, as
you may have read in my other posts, I am also suddenly in extreme
joint pain. So it's possible that my nerve problems are a more natural
anxiety-like reaction to the almost continuous agony in my legs.

My question is, how do I know which it is -- another drug effect, or
merely a natural reaction to pain? Are there tests that might tell me?



Doc 177
609From: marketp@z...
Date: Fri Oct 8, 1999 4:48am
Subject: Re: No Subject

. I
continue to have bone and joint pain and acute burning to my entire
body 17
months later. I also was given steriods to counteract my reaction
which
seemed to escalate it.

17 months! You poor thing. I'll go nuts if I feel like this for a year
and a half. I am virtually bedridden at this point.

Funny thing is, it got suddenly worse, not better, moving from
long-lasting tendinitis to possible arthritis just a couple weeks ago.


Doc 176
605From: Donna Banks <dbmusic@m...
Date: Fri Oct 8, 1999 1:29am
Subject: Re: MRI test

I had MRI's on both knees and ended up having Osteonecrosis
in the knees, hips and shoulders. My situation was
complicated by steroids along with the Levaquin. We don't
know which one really contributed to the necrosis but the
steroids are probably the more likely culprit. The problem is
I was only on the steroids for 9 days along with the
Levaquin. It remains a mystery!

Doc 175
589From: Bizzykidz@a...
Date: Mon Oct 4, 1999 11:36pm
Subject: Re: Cipro

As an almost 6 year veteran casualty of both Floxin and Cipro, reading post
after post I am rarely inspired to post anymore as this is just so insane and
unnecessary - and not to diminish the Levoquin and children posts - come on
people - how about simply "Fluoroquinolones and Children" I say this because
I have been told over the last few years from my childrens dentists,
opthamalogists and other specialties that Cipro is used all the time for
pre-op and post-op, Floxin as well - much prescribed by a top notch
opthamology dept that quinolone drops are prescribed all the time ...and then
me just looking incredulously, so tired of going into my whole ordeal (not
needing any further insult to my suffering) Only two months ago I had to
stop my favorite pediatrician from giving my 12 year old son Floxin drops for
a mild case of his first case of swimmers ear, which first of all says right
on the package insert to be used only for acute otitis media (bad ear
infection) (not indicated for swimmer's ear!!). My children and husband have
been floxed enough having to live with me. And what about poor "Abby" whose
parents recounted her long suffering(and theirs) - a heartbreaking story due
to the effects of Cipro ( on an early post ). Somewhere out there must be
some famous people whose docs have given them fluoroquinolones since these
docs think that fluoroquinolones are the all and end all of antibiotic
treatment, whether or not such treatment is even necessary. I wish all the
pharmaceutical lobbyists to take a course or two of these (their own
medicine) - But, of course, they wouldn't dare!!!!!!!!!!!! Mary

Doc 174
587From: rick@r...
Date: Tue Oct 5, 1999 0:21am
Subject: Re: Levaquin and Children

market-@z... wrote:

Rick, please let me hear more about your symptoms. I took Levaquin 3
months ago and cannot walk. I just had X-Rays of ankles and knees
today. About a week and a half ago, I felt remarkably good, and
perhaps
overexerted myself, because in this past week I need a cane to walk
from my bed to the bathroom. The doctor is somewhat stumped over what
to do. It would be very encouraging to hear from someone who had
similar symptoms but recovered.

I am so sorry to hear of your problems with walking. For the first
month I felt like a character from "Night of the Living Dead" when I
walked, but I could still do so. Between joint pain and dizziness and
vertigo, walking was a real adventure.

My effects from Levaquin (3 tablets and 1 of Cipro in early June)
effects are:

-- joint pain (short term, now just hurts a little bit)
-- incredibly bad neck pain (lingering, much better, but comes and
goes)
-- rotator cuff tendinitis (lingering, comes and goes, but seems to be
trending better)
-- blurred vision in my left eye (lingering, and not getting better,
although I am more used to it now)
-- incredible sensitivity to light in my left eye (short term, gone now)
-- anxiety (I suffered from some GAD already, got worse on Levaquin,
now *much* better)
-- depression (the only bout of depression in my 43 years, fortunately
this only lasted about a month, I'm now taking SAMe)
-- dizziness (lingering, but much better for the last few weeks)
-- insomnia (short term, mostly gone)
-- stomach pain (short term, gone)
-- intestinal upset (lingering, but getting better)
-- fatigue (lingering, but improving)

By either luck or the grace of God (you pick) I haven't had the
terrible neuro-psychological effects that some of you have had, and I
haven't had to miss work. The effects have definitely had a big
negative impact on my life, but between real improvements and coping,
I'm pretty much doing what I used to.

As for treatment, I take ibuprofen for pain, SAMe for depression (I'm
afraid to stop taking it, I've been feeling so well), glucosimine and
chondroitin (I'm not sure it's helping, but what the heck) for the
joints, and get as much aerobic exercise as I can. I also take
supplements, like Arlene, and avoid prescription drugs as much as
possible. Stretching exercises have helped my neck a very little bit.

Ironically, the prostatitis that was the cause of my personal journey
with quinolones persists, and was only helped by saw palmetto and
pygeum -- neither of which are antibiotics or prescription drugs.

-- Rick

Doc 171
582From: Judith Walther <passport@m...
Date: Mon Oct 4, 1999 8:00pm
Subject: Re: ototoxic drugs

I took Cipro for 3 days before waking up intensely dizzy with loss of
balance and nausea. Over a 3 week period gradually got some better, then
was given 2 Floxin. Woke up the next morning with my head and vision
feeling like one of the dolls in the back window of a car. Vision was like
a kid with a camcorder.

Its now 1-1/2 years later and I still can't drive or go back to work. Ears
are constantly full of pressure and feel like they have water in them.
They also ring, balance is bad and I walk into walls. Cognitive function
isn't what it was. Went to vestibular physical therapy which was a help.

When I woke up after the 2 Floxin both shoulders were killing me. Didn't
want to add that to my list of complaints and thought it would go away.
They got progressively worse til I couldn't lift a fork. Took almost a
year for them to get better. Still stiff and achey but livable. The
vertigo/balance is impossible.

Take care,
Judith

Doc 170
581From: shawnee1@s...
Date: Mon Oct 4, 1999 7:36pm
Subject: ototoxic drugs

I'm curious to find out if anyone one the forum has experienced inner
ear pressure or "sounds" in their ears. Research says that many of
these drugs are "ototoxic" meaning toxic to the ear which can cause
titinus, dizziness & vertigo.shawnee1@s...


Doc 169
580From: rick@r...
Date: Mon Oct 4, 1999 7:04pm
Subject: Re: Levaquin and Children

Joint pain was my first indication of an ADR to Levaquin. It has now
been four months since my 3 tablets and I am *nearly* free of joint
pain. I am not back to my previous pain-free normal state, but I don't
feel so bad that I do nothing but deal with pain -- as I spent the
month of June. The symptoms started getting better in about two weeks,
with recurring bad periods for another month or two. I haven't had a
bad spell for a few weeks.

I know it's hard to compare drug reactions between a 43-year-old man
and an 11-year-old girl, but I hope this information helps.

God Bless,

Rick

Doc 168
579From: Jean Jasinski <jean@f...
Date: Mon Oct 4, 1999 11:45am
Subject: Cipro

My husband went to the doctor on Friday because of one-sided testicular
pain. He was told that he had epidydmitis which was an inflammation
only at this point, but that it could turn bacterial. The doctor
gave him an antibiotic prescription to take later IF he gets worse.

When I saw the 'script was for Cipro, I called the doctor and asked for
ANYTHING but a quinolone. This guy is a partner in our family
practice who doesn't know us very well. He called me back to ask why
I was concerned. I told him I'd had an ADR this spring to Levaquin
and Trovan--muscle twitches, fatigue, throat squeezing, joint pain,
low thyroid, and a positive ANA. He said that Trovan and Levaquin
could have caused **some** of those symptoms, but not all of them (no
thyroid impairment and no lupus). But that CIPRO was much less likely
to cause it. In fact, Trovan's been virtually pulled from the market.
Cipro has been on the market forever and that it's less likely to
impact sleep. And that it was **the** most effective drug for this
problem SHOULD MY HUSBAND need it. My husband then took off for a
four week jaunt with the guys with his Cipro. I ordered him NOT to
take it unless his testicle was the size of Montana and he couldn't
straighten up from the pain. And to stop taking it if he gets any
joint pain or throat squeezing.

Jean Jasinski

Doc 167
578From: jmadkins@u...
Date: Sun Oct 3, 1999 9:18pm
Subject: Levaquin and Children

Hi,
I'm new to this board.
My 11 year old daughter who was diagnosed with a bacterial infection
was prescribed several antibiotics that didn't work. She was
hospitalized twice and given IV antibiotics which also didn't work.
Finally she was prescribed Levaquin. The pharmacy told us that it was
normally not used to treat children because it could affect their
growth plates.
Because the bacteria was resistant to most antibiotics, we were
desparate to find something that would cure her so we gave her the
Levaquin.

She finished her prescription although she developed aches in her
joints (elbows, wrists and mostly knees). Over the next month her pain
increased to the point where she was not able to walk. The doctor
prescribed Celebrex and she has been taking this for about 3 weeks.

Until last week, she was not able to attend school since the beginning
of the school year and is now back to school on half days and being
tutored through a program through the school system.

I am curious to know if there will be any permanent damage to the
joints. She still has a small amount of knee pain. Has anyone had
this experience with their children?
Sharon Adkins


Doc 166
I took 3 Levaquin tablets 2 months ago and am still virtually crippled
with tendinitis and joint pain. Like you, my doctor says quinolones
cause only regular tendinitis, which is a slow-healing condition;
however, again like you, I have had the "real thing" and this kind of
tendon damage is much longer lasting.

What do I do? Is there any cure? Is there information I can provide my
doctor to make him believe me? Please help.


Doc 189
716From: mavill@h...
Date: Thu Oct 21, 1999 6:01pm
Subject: I'm Back

Hello, everyone!

Yes, I've been quiet lately, but now I'm back. After two Levaquin tabs
in March 1999, I'm finding that some symtoms improve, some worsen, and
some just stay the same. The nerve damage causing the visual problems
persists with no improvement, but I have observed fewer instances of
involuntary muscle contractions. I still experience occasional burning
in the left calf. Most frightening is the onset of pain in my right
hip and right foot. It happens mainly when it is cool and/or rainy.
It feels like what I always thought severe arthritis would be. I'm
only 37 years old, and there's no history of anything like this in my
family. I probably wouldn't even be so bold as to blame the Levaquin
for it except that I remember the joint pain that occurred when the
reaction began.

One interesting note this week: I read with raised eyebrows that a
Pentagon-financed study has concluded that a drug (pyriostigmine
bromide) given to US troops during the Persian Gulf war to protect
against nerve gas cannot be ruled out as a cause for Gulf War Syndrome.
Some of the symptoms of GWS include chronic pain, digestive problems,
nausea, skin rashes, fatigue, aching joints, memory loss, and
concentration problems. Does this sound too familiar??? The Pentagon
has earmarked $20 MILLION to specifically study the effects of this
drug.


What I'd like to know is why it took so long for them to figure out
that to get an educated opinion about what was causing these symptoms,
they should completely bypass medical doctors and go straight to a
rocket scientist. (Yes, I'm back and I'm still mad.) Why didn't they
just listen to the people who have GWS? The victims of GWS had to have
a fairly good idea of what could have caused their symptoms. I wonder
how many of them are like us, trying to find doctors who won't blow
them off as nutcases.

Now, if these geniuses would just start looking into quinolones.........
Anyway, it would be nice if the government (read FDA) would earmark a
little money to research adverse drug effects caused by quinolones.

Anita

Doc 188
Date: Wed Oct 20, 1999 5:12pm
Subject: Re: Adverse reaction

"donna banks" <dbmusi-@m... wrote:
original article:
http://www.egroups.com/group/quinolones/?start=702
Hi, am I to understand you are in a wheelchair or did I just
misunderstand your message to eileenro? If you are can you tell me
what your symptoms or pain is and weather you took any steroids in
conjunction with the Levaquin. I was in a wheelchair for 8 months and
would like to compare.

I haven't taken any steroids, although the rheumatologists I saw for
the problem wanted to shoot me full of them. Luckily I had a copy of
the Harrel article and scared them off.

My limb symptoms started while on the drug -- shooting or ripping pain
in my calves, sharp pains in my Achilles, and sharp pains in my knees.
Every joint in my body, but especially my knees and ankles, made large
popping noises normallly referred to as "cracking," as when you crack
your knuckles. While taking the Levaquin I found symptoms moderated
slightly when I drank huge quantites of water, but after only three
pills I couldn't take it any longer.

That was three months ago. My symptoms have worsened considerably
since. For a long while I was able to go on walks up to about an hour
before feeling pain. The interval shortened and I started on a cane.
One month ago I began to feel an unspeakable pain in my left knee -- a
burning, ripped sensation, as if an animal had tried to tear my lower
leg from my body. It worsened when I stood up, regardless of whether I
was placing any weight on it. About two weeks ago, it became
unbearable. I could not walk from my bed to my bathroom. That's when I
went into the wheelchair, where I remain.

All the doctors are stumped, but none have dealth with FQ before. I had
an MRI today and I'm starting physical therapy next week, so we'll see
whether i have any more interesting news to report.

Doc 187
eileenro-@aol.com wrote:
original article:
http://www.egroups.com/group/quinolones/?start=693
After taking Levaquin for 10 days (I did not connect my symptoms with
the antibiotic), I still have terrible leg pains and numbness in my right
hand. When I told my doctor that I had to stop taking it because of the
pain in my joints, he said "you're the 4th or 5th person to tell me that" - I
wonder why he did not warn me so that I would have stopped as soon as the pain
in my knees started.

Doc 186
Unless your doctor is completely clueless -- when it comes to FQ
reactions this is a pretty common state -- you've already heard that
you should take extraordinarily good care of your tendons.
Hear, hear. For now, I'd treat them as if they are more severely
injured than they feel.
My doctor told me that I had simple tendinitis coming off the Levaquin
and should recover in three weeks. I am in a wheelchair after three
months. Tendons are normally slow-healing parts of the body anyway.
FQs make the matter worse.
I'm not a doctor or an expert, just a victim. But if I had to do it
all over again, here's what I wish I had done (besides, of course, not
take the Levaquin): A few days, maybe a week of serious bed rest.
After that, very gentle stretches if not too painful -- or even better,
professionally supervised physical therapy. A solid month spent in a
good running shoe with strong support, leaving the snazzy black
leathers in the closet for now.
It is important to avoid walking oddly, which is your natural reaction
to leg joint pain. I did, and now have bursitis and severe knee
problems.
Hopefully, you will be one of the lucky ones who clears up in a month.
Best wishes.

Doc 185
731From: AtwoodJim@a...
Date: Mon Oct 25, 1999 8:41am
Subject: Achilles pain...does it go away?

First of all, I'm so glad to have found this forum! I've been taking Cipro
(500 mg twice a day) for prostatitis for 4 weeks. Last week I remarked to my
wife that my age must be showing at long last....my Achilles tendons are
constantly sore.

I'm off Cipro as of this morning. Now I'm wondering if this constant soreness
goes away? What should I expect in the way of healing or a return to normal?


Doc 184
722From: Luffagus@a...
Date: Fri Oct 22, 1999 8:50pm
Subject: Re: Stomach Problems

Thank you all for the info on stomach and abdominal problems in relation to
quinolones. I knew I wasn't nuts.
I developed pancreatits after taking floxins a few years back and although
the test results (amalyse,lipase,tripson) come back very elevated the Doctors
cannot seem to find a source or diagnoise what is causing it.So I take
Pancrease daily when I eat.
Has any else had these tests? I understand pancreatitsi will also cause
muscle,joint pain.
I am curious to know if anyone else had these tests.
Also, I have to add that although I feel the Doctors should have been more
concerned and look into the floxins, leviquin as an ADR. I believe they were
trying to help me and really felt that when I told the of the ADR they felt I
had too many problems for them to deal with. If my problems were all in my
head the blood tests would not show anything. ALTHOUGH I am told that the
pancrease tests will show neg. when in fact they are positive. It is the way
the pancrease works.
I don't care if I feel insulted when the Doctors look at me like I have 2
heads. I need someone to help me... Seriously...I am tired of being sick,sick
of pain,cannot seem to get out of it...ever.
The only time I had any relief was when I took natural medicine for liver and
intestinal cleansing.That was the only relief since 1993 and it only lasted
7days.
I feel like whatever I have is an infection and it is in my bones.It feels
like it is under the skin in my bones and blood.
Has anyone had bronchitis? spasms in the lungs?
I appreciate the feedback. I am not interested in help not vengenance.

Doc 183
720From: marketp@z...
Date: Fri Oct 22, 1999 5:45pm
Subject: Torn cartilage

My MRI shows a degenerated and possibly torn meniscus, which is the
cartilage that joints the tibia and femur in your leg. Has catilage
injury happened to anyone else on this board?

I have an appointment with an ortho/sports doctor, but his nurse
practitioner was very skeptical about the possibility of joint injury
occuring from quinolones. I will try not to strangle her with my bare
hands, although I might get better health care in jail.


Doc 182
719From: cbrigante@m...
Date: Fri Oct 22, 1999 3:14pm
Subject: vision

Hi - It's Judy again - I haven't mentioned vision probs. yet but I do
have them too. Since being FQ'ed,my glasses need to be strengthened
every 2 months. Optician "can't figure it out", but I can. I can't
afford 6 new prescriptions for glasses a year so I'm just toughing it
out & getting used to not seeing as clearly as I used to. Glasses used
to last me several years before needing strengthening before FQ. I
thank God I don't have nausea,dizzyness, etc. or drastic vision
problems, so vision, altho important God knows, has not been a priority
with me to focus on (no pun intended). There is another product that
can be bought in GNC called "Colloidal Silver". It's expensive, $12
for 4ozs. but at GNC, you can return products for cash with a receipt
if you want to. That's the only reason I tried this stuff, because I
knew I could return it for a full cash rebate if necessary. it looks &
tastes like water & I was very skeptical, but now I'm a believer.
Bladder infections, tooth infection with pain, these are just 2 of the
conditions I've used this for. 5 dropperfuls a day, not taken with
food are the instructions. We need to share remedies & get away from
allopathic medicine wherever possible. Sometimes surgery & such is
really necessary, but, for me, maintenance medicine will from now on be
mainly homeopathic & remedies wherever possible. Just remember, go
slow, til you see if there will be any adverse reaction to you from
anything new, whether allopathic or homeopathic. Bless all
Judy

Doc 181
Levaquin, on the other hand, is causing me some problems. I just finished
taking a 10-day course, and didn't really realize until I swallowed the last
pill -- and then found your web site and email list -- that my severe knee
and joint pain was an adverse reaction to the drug. Getting up and down
from chairs and car seats is difficult. I can only hope that it subsides.
I also am experiencing numbness and tingling in my extremities. This is
similar to -- but worse this time than -- a reaction I had 7 years ago to
Orudis. One doctor told me at that time that I couldn't possibly be having
a reaction to it, but a neurologist I consulted said, "Yep, it's one of the
known -- although rare -- side effects, and didn't question it. He said it
would take 6 months to a year for the nerves to regenerate from the damage
of about a week's worth of medication! And the tingling/numbness is worse
with Levaquin.

I'm thankful to have stumbled upon this site.
Susan

Doc 180
630From: Amy <ALou-2u@p...
Date: Sun Oct 10, 1999 6:27pm
Subject: Levaquin, / Side effects

I have been on Levaquin for 6 days after I had a severe drop
in White Blood count from Vancomycin. Anti-biotic treatments
began 6 weeks ago after surgery for Osteo-Myelitus, ( an
infection of the bone) . I am experiencing , sleeplessness,
Chest tightness, rapid heart rates , dizziness, and general
weakness.


Doc 18
145From: keith h baldwin <ljb40@j...
Date: Thu Mar 25, 1999 10:26pm
Subject: feeling bad also

The 24th of this month makes 3 years since I have been floxed as Stephen
Fried once put it about his wife. I am no better either. Still have my
dizziness and pressure in the head. Now I am having nausea again, it had
left me for about 3 months. And of course the usual body aches. It is
raining here in California, maybe thats why I feel bad. I wish!
Thanks for answering me. Thought maybe everybody had dropped of the
earth.
Linda

Doc 179
611From: Cdolkas@a...
Date: Fri Oct 8, 1999 0:45am
Subject: Re: MRI test

Several MRI's done over 3 years (dr wanted to rule out MS or tumors) MRIs
within norm.However PET scan was done and showed significant damage(metabolic
disfunction) and neurological disfunction of different portions of the
brain,consistent with severe seizure disorder(not Gran Mal ).Whoopee so I
have a picture that documents how I feel. Good Luck to all.

Doc 196
783From: leecarter@u...
Date: Sat Oct 30, 1999 2:57pm
Subject: Adverse Reaction

Hello Everyone -

I was recently prescribed Levaquin for chronic bronchitis. I am an
asthmatic who suffers from bronchitis twice a year. This time, the
doctors could not clear it up and I ended up in the hospital for 2 days
and was given Levaquin. When I began experiencing side effects when I
got home, my doctor told me it was the steroids that were causing it
and to try to stagger the dosage. That did nothing to stop the
dizziness, nausea, muscle weakness, and confusion I was suffering. I
couldn't even drive my own car for fear I would wreck. The doctor
simply refused to believe it was the Levaquin. I finally began taking
the Levaquin in the middle of dinner. I would eat half of my meal, take
the pill, then finish the meal. I would then drink about 1 quart of
water slowly afterwards. After that, I would lay down and sleep for
about a half hour. Although the side affects continued, they were much
reduced. I take my last dose tomorrow and am thrilled it is over. What
suprised me the most was that I could not get any of my doctors to
prescribe a replacement antibiotic. I called my pulmonologist, and two
primary care physicians. They all told me to simply ride it out, stay
home from work, and let the medicine work. While the levaquin was very
effective in ridding me of the infection, the side effects were
horrific. Had it not been for this group, I would have had no idea that
what I was experiencing was actually a normal reaction to the
medication. I thought I was going crazy. Besides being physically weak,
I was unable to concentrate on even the most mundane of tasks, like
reading or eating. I read through a few of the messages to get an idea
of the side effects, but I did not read further to find out what can be
done to make this drug safer or to get it off the market. Can anyone
let me know what is being done and what I can do to help with this
effort.


Doc 195
article:
http://www.egroups.com/group/quinolones/?start=489
Help! My husband may have had a reaction to floxin. We have
conflicting reports from MD's concerning his current condition. After taking
floxin for 5 days he experienced 2-3 anxiety-type attacks!?!
The majority of his pain was in his back, could not grasp objects,
sensitivity to light, ached all over. He went to the emergency room and was told
it was probably a reaction to floxin-he discontinued his use. After 2 days
of bed rest the pain went away, except he continues to have pain in his
lower back. He is now in physical therapy for the constant pain.
Can you please shed some light on floxin reactions? Our family
practitioner says this is not a floxin reaction. We obviously
are very frustrated with the medical run-around we have been receiving
lately.
Thank you.


Doc 192
753From: Jean Jasinski <jean@f...
Date: Wed Oct 27, 1999 11:03am
Subject: Class 1

I suspect that I am a Class 1 ADR sufferer. I took 20 days of Levaquin
and 5 days of Trovan in March/April of this year. My symptoms started
during the second ten day round of Levaquin.

Virtually all of the joint stiffness and fatigue is gone. I still
have more (than before) muscle twitches in bizarre places. I am still
taking a slightly higher dose of Synthroid than before and suspect
my ANA titer would still be positive.

One interesting point: during the time I was being floxed, I was
enrolled in a study for head injury patients. The study involved taking
6 weeks of a placebo and 6 weeks of an Alzheimer's medication called
Aricept. Aricept is an acetylcholinesterase inhibitor which is
improves memory. It certainly improved my memory--there is no way I
could have survived the semester (organic chemistry) and floxing had
it not been for the Aricept (5 mg). Now I wonder if the Aricept could
have had anything to do with the reducing the severity of the ADR.

Jean Jasinski

Doc 191
October 27 1999

Glaxo Pulls Antibiotic On Safety Fears

By Jonathan Birt, European pharmaceuticals correspondent

LONDON (Reuters) - Britain's largest drugs group, Glaxo Wellcome Plc
(NYSE:GLX - news), said Wednesday it had decided to withdraw a
powerful antibiotic from the market worldwide, after it was linked to
seven deaths.

The company said it was pulling Raxar, known generically as
grepafloxacin, from sale in 36 countries including Germany and the
U.S. because of ``a small number of severe cardiovascular events among
patients.''

The fluoroquinolone antibiotic, normally prescribed for infections
such as pneumonia, bronchitis and some sexual conditions, has been
linked to seven deaths, although its role has not been proved.

A company spokeswoman said it had also been associated with two
confirmed cases and one unconfirmed case of a rare form of irregular
heart beat known as torsades de pointes arrhythmia.

The company said it acted voluntarily after discussions with
regulators and heart experts, adding that as a number of alternative
drugs were available, it no longer regarded the risk involved as
acceptable.

The drug, launched in December 1997, is one of Glaxo's
smallest-selling products. It has been prescribed more than 2.6
million times since its launch, with the U.S. and Germany the largest
markets.

Raxar is the second fluoroquinolone antibiotic to run into trouble
this year. In June, U.S. regulators recommended doctors severely limit
use of Pfizer Inc (NYSE:PFE - news).'s antibiotic Trovan after it was
linked with 152 cases of serious liver damage, including possible
deaths.

Raxar, sold as Vaxar in some markets, was licensed from the Japanese
drugs group Otsuka Pharmaceutical Co.

Glaxo said it did not expect any legal challenge resulting from the
withdrawal or safety issues, pointing out that potential side effects
were clearly labeled.

Doc 190
746From: Copycat008@a...
Date: Tue Oct 26, 1999 7:44pm
Subject: Re: thinking of you

I don't read much of the mail here, as it does not pertain to me. My husband
died while taking trovan, and of course, there isn't much trovan news. I
read your letters and I cry at your pain, but I wish my husband were here to
write his own letters. I have not had any luck with my persuit for answers.
I live in Kansas and there is only 1 pathologist here who will exhume a body
and do an autopsy, as there was not one done at his death, and no blood work,
either, and I have not heard anything one way or the other if this
pathologist is going to take me on. I just keep my fingers crossed, because
without any evidence, I cannot even get a lawyer to talk to me. I feel so
badly for all of you, hang in there, I am trying to. Nancee