An Open Letter to the Congressional Commitee Investigating Severe,
Disabling reactions linked to Cipro, Levaquin, and Other Fluoroquinolone
Antibiotics.

Dear Congressman Holt,

I would like this letter to be entered into the record in your
hearings on fluoroquinolone antibiotics (e.g. Levaquin, Cipro, Floxin,
Tequin). I am the author of a study about severe, long-term
fluoroquinolone reactions published in the December 2001 issue of the
Annals of Pharmacotherapy.1 Actually, the publisher and I pre-released
this article in October 2001, during the anthrax scare when Cipro was
being prescribed indiscriminately and without warnings to patients.
Within days of publication of my paper, the U.S. Centers for Disease
Control changed their guidelines, placing the antibiotics doxycycline
and penicillin above Cipro as the preferred treatments for anthrax
exposure. Doxycycline and penicillin are associated with fewer severe
side effects than fluoroquinolones, and they are not linked with the
devastating, disabling, long-term reactions that my study identified.

These severe reactions are occurring in patients who are usually
healthy, active, and young. Most often, the antibiotics are prescribed
for mild infections such as sinusitis, urinary or prostate infections.
Most reactions occur very quickly, sometimes with just a few doses of
the fluoroquinolone antibiotic. Reactions are acute, severe,
frightening, and often disabling. In most cases, side effects are
multiple, involving many systems of the body. In my study, nervous
system symptoms occurred in 91% of patients, musculoskeletal 73%,
sensory system 42%, cardiovascular 36%, skin 29%, gastrointestinal 18%.
These numbers do not adequately capture the severity and permanence
of these reactions. Here are some examples:

Male, age 36, previously in good health, received Cipro for possible
urinary infection: Chronic, debilitating multi-focal neuropathy,
fibromyalgia, chronic fatigue, gastrointestinal problems, heart
arrhythmia requiring pacemaker, carpal tunnel syndrome, chronic multiple
joint pains, chronic pain. Functional ability: disabled. Duration: 5
years (patient now age 41).

Female, age 32, previously in good health, received Cipro for urinary
infection: After 5 days, developed pain in wrists, neck, back, knees,
hips, elbows, shoulders, and Achilles tendons. Having difficulty
writing. Medical workup normal. Functional ability: greatly limited.

Female: age 47, previously in good health, received Levaquin for
sinusitis: Within 2 days developed joint pain (severe in hands),
insomnia, severe agitation, weakness, dizziness, severe fatigue, mental
infusion, abnormal dreams, gastrointestinal symptoms. Duration: Still
severe after 7 months.

Female, age 49, previously in good health, received Floxin for a pelvic
infection: Burning pain, memory loss, joint pains, palpitations, nerve
pain, insomnia, abnormal sense of smell, tinnitis, panic attacks.
Duration: more than 3 years.

Male, age 34, previously in good health, received Levaquin for prostate
infection: Muscle spasms and twitching, numbness, impaired coordination,
weakness, increased sensitivity to temperatures, fatigue, multiple
joint, muscle pain, palpitations, blurred vision. Duration: more than 1
year.

Male, age 35, in good health, received Levaquin for prostate infection:
1 dose was followed by ringing in the ears and peripheral nerve symptoms
lasting 2 weeks. Then tendonitis began in shoulders, elbows, wrists,
hands, and Achilles tendons, with burning pain and tightness in calves.
After 2 months, still unable to walk more than a short distance. This
man told me, "Prior to taking the medication I asked about side effects
and was told there were none for adults except an upset stomach.
Afterwards I was told that what I was experiencing could not be related
to the drug. Obviously the doctor had never read the documentation that
states otherwise."

These are not isolated cases. Since the publication of my article
with its 45 cases two and a half years ago, I have received e-mails from
more than 100 people seeking help for their reactions. In most cases,
their doctors have dismissed their complaints or outright deny that the
reactions could occur with fluoroquinolones. Yet extensive medical
workups do not find any other cause. Worse, there are no known effective
treatments. Thus, these people suffer pain and disability for weeks,
months, years.

Overall, my sense is that these reactions are not rare. I have
spoken to the U.S. Food and Drug Administration about this. I am shocked
that the agency still hasn't acted. Other major reactions such as
Stevens-Johnson syndrome or Churg Strauss syndrome from medications are
posted prominently on drug labels. These reactions are much rarer than
the ones occurring with fluoroquinolone antibiotics. At the very least,
black boxes should be placed in fluoroquinolone package inserts about
severe, multi- system reactions.

I readily agree that fluoroquinolone antibiotics play an important
role in treating infections diseases, but we must alert doctors and
patients about the potential devastating effects linked to these drugs.
We must educate them that if any signs of reactions occur, such signs
should be reported immediately and the drugs should be discontinued.
Patients have a right of informed consent, and this includes warnings of
potential serious, disabling reactions. Most of all, we must educate
doctors to avoid prescribing fluoroquinolones for minor infections,
instead saving them for serious infections, just as we do with other
groups of antibiotics with serious toxicities.

I hope you will look seriously at this problem and respond
accordingly. These people need your help. This is a largely preventable
problem. Thank you.

Jay S. Cohen, M.D.
Associate Professor (voluntary)
Departments of Family and Preventive Medicine and of Psychiatry
University of California, San Diego

President and Executive Director
The Center for the Prevention of Medication Side Effects
A Nonprofit, Tax-Exempt [501(C)(3)] Corporation

REFERENCE:
1. Cohen, JS. Peripheral Neuropathy with Fluoroquinolone Antibiotics.
Annals of Pharmacotherapy, Dec. 2001;35(12):1540-47.

Copyright 2004, Jay S. Cohen, M.D. All rights reserved. Readers have
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The video is heart rending. I had a similar experience with Levaquin but I was
able to get help from a psychiatrist.  It is important to realize that this
kind of severe reaction is not common. We still need antibiotics, and yes,
Cipro (and Vitamin C) did help my prostatitis.  I hope Bob gets help. I know
how he feels.

You are welcome, a.shole no. one.