[e-drug] WSJ on side effects of Fluoroquinolones

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E-drug: WSJ on side effects of Fluoroquinolones
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WSJ on side effects of Fluoroquinolones

October 26, 2001 
Health Journal
 
Surge in use of Cipro spurs concerns about side effects
By Tara Parker-Pope

After anthrax fears spurred everyone from New York's governor to
hundreds of postal workers to take the antibiotic Cipro, drug-safety
experts are now predicting a rash of health problems caused by the
drug itself.

Most troubling is the fact that three similar drugs, all chemical
cousins of Cipro, already have been pulled off the market after
being linked with severe side effects and even death.

Cipro, or ciprofloxacin, is one of several fluoroquinolones, a
controversial class of antibiotics that can cause a range of bizarre
side effects: from psychological problems and seizures to ruptured
Achilles tendons. Fluoroquinolones made by other manufacturers,
such as Johnson & Johnson's Levaquin, also are being considered
for use in treating anthrax exposure.

Cipro is generally regarded as safe, but concerns are growing as its
use surges amidst the anthrax scare. And some of the potential side
effects of fluoroquinolones, such as cardiovascular complications,
simply haven't been widely studied."

"I'm very concerned. There are safer drugs that are available for
this, and they're not being used," says Raymond Woosley, vice
president, health science, University of Arizona in Tuscon.

Bayer declined to comment on questions about Cipro side effects.

At tabloid publisher American Media, where the first case of
anthrax was diagnosed and many workers are taking Cipro, some
have complained of stomach upset or feeling "spacey" since taking
the drug. One employee had a severe allergic reaction and another
suffered a seizure; both were hospitalized, according to an AMI
employee who asked not to be named. Some workers there, after
researching side effects, have asked to switch to other antibiotics.

When first introduced 15 years ago, fluoroquinolones were
celebrated as effective bacteria fighters without the resistance
issues that sometimes render more traditional antibiotics ineffective.
As use has grown, resistant strains have emerged, but the drugs
remain some of the most heavily prescribed antibiotics.

But in 1992 Abbott Laboratories' temafloxacin, marketed as
Omniflox, was withdrawn after only three months following 50
severe cases of adverse reaction, including three deaths. In 1999,
14 cases of acute liver failure, including five deaths, were linked to
Pfizer's drug trovafloxacin, marketed as Trovan, prompting the FDA
to severely limit its use. Later that year, Glaxo Wellcome's
grepafloxacin, marketed as Raxar, was withdrawn after reports of
heart rhythm abnormalities, with seven deaths.

Fluoroquinolone users who have suffered severe side effects call
themselves "floxies" and have created their own Web site
(www.geocities.com/quinolones). The Annals of Pharmacotherapy
published a review of 45 cases of severe adverse effects from
quinolones, including 11 cases involving Cipro. The Philadelphia law
firm Sheller Ludwig Badey has been involved in about two dozen
cases of severe quinolone side effects.

Doctors say that, in general, fluoroquinolones don't carry any higher
rate of side effects than traditional antibiotics. But the nature of the
side effects of fluoroquinolones often are so strange, patients often
don't associate them with the drug.

David A. Flockhart, professor of medicine and chief of clinical
pharmacology at Indiana University School of Medicine, says as
many as a third of patients taking a fluoroquinolone will experience
some sort of psychiatric side effect, such as anxiety, personality
change or confusion. "The psychiatric effects of the
fluoroquinolones are underappreciated by the medical profession as
well as by the public," says Dr. Flockhart, who has treated more
than 100 patients with severe psychiatric side effects.

Dr. Flockhart says the drugs are useful in treating infection because
they quickly reach high concentrations in the blood. That means the
drugs can quickly concentrate in the brain and interfere with a
receptor that normally prevents seizures.

After taking a single dose of Johnson & Johnson's Floxin for a mild
urinary tract infection, 36-year-old Diane Ayres suffered a severe
manic reaction with confusion, vision problems and insomnia.
Doctors blamed the Floxin, and the episode left her with
manic-depressive illness. "These are drugs that should be reserved
primarily in situations where another drug has failed," says her
husband, Stephen Fried, who has written a book, "Bitter Pills:
Inside the Hazardous World of Legal Drugs."

Fluoroquinolones also are known to trigger another bizarre side
effect -- tendon rupture, particularly the Achilles. Kansas
dermatologist J. Michael Casparian took Cipro five years ago for a
cough. Six months later he was playing charades in his living room
when he experienced what felt like "a baseball bat hitting my
ankle." A few years later, his other Achilles tendon snapped.

It's unclear why some people react to fluoroquinolones while others
do not. Someone with an existing psychiatric condition, seizure
disorder or with a history of head trauma shouldn't take
fluoroquinolones. In addition, a patient who is prescribed a
fluoroquinolone should ask whether another antibiotic, particularly
one they've used before without ill effect, couldn't be used instead.

E-mail comments to healthjournal@wsj.com


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