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Scientific study on side effects of quinolones attn Dr Klein

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I think what is disturbing about this information is that it would be

completely overlooked by the prescribing physician. These side effects are

considered rare, but that may be because no one realizes what is happening.

The worst cases would be ones like mine where the diagnosis of chronic

fatigue syndrome would already look exactly like the side effects while, at

the same time, the doctor would be prescribing a quinolone to treat the

borrelia infection of chronic Lyme disease. Can't win for losing.

a

THE ANNALS OF PHARMACOTHERAPY

FOR IMMEDIATE RELEASE

October 22, 2001

Contact: Stanley J. Lloyd, PharmD

Telephone: 513/793-3555

FAX: 513/793-3600

E-mail: theannals@...

www.theannals.com

PERIPHERAL NEUROPATHY ASSOCIATED WITH CIPRO

CINCINNATI, OH - Adverse effects associated with the use of ciprofloxacin

(Cipro) and other fluoroquinolone antibiotics are not always benign. Not

infrequently, they can be severe and permanently disabling, and they may

occur following just one or a few doses, according to a study posted on The

ls of Pharmacotherapy Web site today. Scheduled for publication in

December 2001, this article is being made available now on the Internet

because of the threat of anthrax and subsequent heightened interest in

Cipro.

Jay S Cohen, MD, an Associate Professor of Family and Preventive Medicine at

the University of California, San Diego, and an expert on adverse medication

reactions, analyzed 45 cases in which fluoroquinolone antibiotics (including

11 involving ciprofloxacin) were associated with adverse effects involving

the peripheral nervous system such as tingling, numbness, burning pain,

twitching, or spasms. Moreover, 42 (93%) of these patients also sustained

adverse effects involving other systems. Seventy-eight percent experienced

central nervous system (CNS) symptoms such as dizziness, agitation, impaired

cognitive function, or hallucinations, and 73% reported musculoskeletal

symptoms such as joint or muscle pain or tendon rupture. Adverse events also

involved the cardiovascular and gastrointestinal systems, skin, and special

senses in 18%-42% of cases.

Assessments of severity revealed 2 cases that were mild (4%), 7 moderate

(16%), and 36 severe (80%) with chronic pain and/or significantly limited

normal function. Symptoms were typically long-term with 91% exceeding 1

month in duration, 71% exceeding 3 months, and 58% exceeding 1 year. Twelve

cases (27%) lasted longer than 2 years. These severe, long-term reactions

occurred in a generally young and healthy population. The average patient

age was 42 (range 11-68). Sixty-two percent had no other medical disorder

except the infection (mainly sinusitis, prostatitis, urinary infections)

that prompted fluoroquinolone therapy.

Onset of adverse events was usually rapid, with 15 cases (33%) beginning

within 24 hours of starting fluoroquinolone treatment, 26 (58%) beginning

within 72 hours, 38 (84%) occurring within 7 days, and 43 (96%) within 14

days. While some patients reported that their physicians acted promptly to

discontinue the antibiotics when symptoms occurred, 18 patients stated that

their physicians either failed to recognize or dismissed the significance of

their neuropathies or more commonly recognized events such as joint pain,

tendon pain, or CNS symptoms. At least 4 patients reported being told to

continue taking the antibiotics despite complaining of adverse events.

Fourteen patients received more than one course of fluoroquinolone

treatment; in each case, adverse events had occurred with the initial

prescription. Apparently, these physicians did not know that fluoroquinolone

toxicities may be cumulative.

Because of the current anthrax threat and the hoarding of ciprofloxacin by

thousands of people, it is imperative that physicians and the public

understand the benefits and potential risks of using ciprofloxacin or other

fluoroquinolone antibiotics indiscriminately. The media have, generally,

presented only a few fluoroquinolone adverse effects, which are usually

described as mild and brief. There are anecdotal reports of people already

taking ciprofloxacin prophylactically. The cases presented in this article,

as well as previously published articles about the adverse effects of

fluoroquinolones, should give patients and physicians pause before using

fluoroquinolones unnecessarily, especially because other, safer antibiotics

(penicillin, doxycycline) can often be used instead. Moreover, people need

to know that not all serious reactions associated with fluoroquinolones are

listed in package inserts or the Physicians' Desk Reference. People must be

informed that with the development of any musculoskeletal, or peripheral or

central nervous system symptoms, fluoroquinolone treatment should be

discontinued immediately unless medical circumstances (e.g., severe

infection and no alternative treatment) warrant otherwise. Patients

sustaining these reactions should not receive fluoroquinolone antibiotics in

the future.

Dr. Cohen can be reached at 858/509-8944 (FAX) or jacohen@....

The ls of Pharmacotherapy is the leading international journal featuring

articles directly related to pharmacotherapy, the area of pharmacy practice

that promotes the safe, effective, and economical use of drugs in patients.

Some other recent articles that have appeared in The ls of

Pharmacotherapy covering quinolones, and ciprofloxacin in particular,

include:

Paladino JA. Is more than one quinolone needed in clinical practice? Ann

Pharmacother 2001 Sep;35(9):1085-95.

MacCara ME, Sketris IS, Comeau DG, Weerasinghe SD. Impact of a limited

fluoroquinolone reimbursement policy on antimicrobial prescription claims.

Ann Pharmacother 2001 Jul-Aug;35(7-8):852-8.

Alghasham AA, Nahata MC. Clinical use of fluoroquinolones in children. Ann

Pharmacother 2000 Mar;34(3):347-59.

Temple ME, Nahata MC. Interaction between ciprofloxacin and rifampin. Ann

Pharmacother 1999 Jul-Aug;33(7-8):868-70.

Otero MJ,Moran D, Valverde MP. Interaction between phenytoin and

ciprofloxacin. Ann Pharmacother 1999 Feb;33(2):251-2.

The publisher of The ls of Pharmacotherapy, Harvey Whitney Books

Company, along with its Editorial Office, is located at 8044 Montgomery

Road, Suite 415, Cincinnati, OH 45236, USA, www.theannals.com.

Date: Tue, 9 Dec 2003 11:29:56 -0800 (PST)

From: Joe Klein <epistrophy1@...>

Subject: Re: attn Dr. Klein

I am not familiar with Levaquin toxicity. I did a search on Google (used

" Levaquin toxicity " ) and did come up with numerous references. However, a

lot of the references seemed to be individual testiomonials which cannot be

taken as credible medical resources. You would be best off consulting an

infectious deisease specalist or perhaps a toxicologist.

ph P. Klein, Sr.,M.D.

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