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| BIOTERRORISM: CIPRO, ANTHRAX, SMALLPOX AND YOU |
| PART 1: CIPRO ADVERSE SIDE EFFECTS |
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Antibiotics Like Cipro Are Linked to Tendon, Psychiatric Problems
By Tara Parker-Pope
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October 26, 2001. (The Wall Street Journal) - 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 Tucson.
"If they knew the risk of seizures and major psychosis, I don't think they would take it. I wouldn't."
Bayer says Cipro has a 14-year safety record, with 850 clinical trials and 300 million prescriptions.
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 of feeling "spacey."
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 have asked to switch to other antibiotics.
But in 1992, Abbott Laboratorie's temafloxacin, marketed as Omniflox, was withdrawn after only three months following 50 severe reactions, including three deaths.
In 1999, 14 cases of acute liver failure, including six 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 Philadephia 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 under appreciated 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.
He theorizes that because they more quickly to the brain, they 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 a history of head trauma, and children 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, shouldn't be used instead.
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Cipro Use May Raise Seizure Risk For Some
By Melinda T. Willis
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October 29, 2001. (ABCNEWS.com) - The Epilepsy Foundation warns of seizure risk associated with Cipro.
Some people may be at higher risk of having a seizure if they take the antibiotic Cipro - now in demand as an anthrax treatment - the Epilepsy Foundation warns.
"There is a risk of a lot of indiscriminate use of this drug," says Dr. Gregory Barkley, medical director of the Comprehensive Epilepsy Program at the Henry Ford Health System in Detroit Michigan, and chair-elect of the Epilepsy Foundation professional advisory board.
Cipro sales have skyrocketed in the wake of recent anthrax exposures in the United States.
Earlier this week, Bayer announced that it would triple production of Cipro and ship 200 million tablets in the next three months.
| "It is not unique in that this is the only antibiotic to cause seizures. . .but the risk of seizure is a bit more likely with this drug compared to others." - Dr. Gregory Barkley, chair-elect of the Epilepsy Foundation |
The drug is also available online without a prescription.
This Situation further removes many potential Cipro users from the care of a physician, and increases the likelihood of harmful drug interactions and reactions that may increase seizure activity.
Antibiotics in the same class as Cipro, known as fluoroquinolones, can sometimes cause seizures in people who have epilepsy as well as in others who are at risk of seizures because of prior head trauma, stroke or tumor or a family history of seizures.
"It is not unique in that this is the only antibiotic to cause seizures," says Barkley.
"But the risk of seizure is a bit more likely with this drug compared to others."
High levels of caffeine and stress have been shown to increase the odds of having a seizure and Cipro use may raise these odds even further.
There are also reports that non-steroidal pain relievers, such as aspirin, can raise the risk of seizure when taken along with Cipro.
Additionally, "there is evidence that Cipro can interfere with the way that the body handles epilepsy drugs and lower the level of the drug in the body," says Dr. Robert J. Gumnit, president of MINCEP Epilepsy Care in Minneapolis.
While the overall odds of having a seizure while on Cipro remain low, less than 1 percent experts emphasize caution.
"If you have seizures or a family history of seizures, wait until you have been positively diagnosed [with exposure to anthrax] before you take an antibiotic and ask your doctor about taking penicillin or doxycycline," says Gumnit.
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Cipro Adverse Side Effects
By Paul Sperry, WorldNet Daily
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October 29, 2001. (Washington) - Clinical trials show ciprofloxacin HCI causes some nasty, even life-threatening, side effects.
Good news is they're rare.
Only, trials are based on a normal 7-to-14-day therapy, the dosage prescribed for ailments like urinary tract infections, ciprofloxacin's typical treatment, and not the exceedingly long 60-day course for anthrax, whether it be the inhaled form or less-lethal skin form.
Ciprofloxacin, which is sold under the Cipro brand name, has never been tested in anthrax-exposed humans.
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"It's not candy, yet people are popping the white pills as if they were Tic-Tacs."
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The risk of anthrax infection remains for at least 60 days because of the possibility of delayed germination of spores, which are hardy and can survive a long time, even in an open environment.
Thanks to the anthrax-by-letter scare, thousands of Americans are taking the two-month Cipro regimen, either on the advice of public health officials and doctors, or on their own.
In Florida, New York and Washington's Capitol building, more than 2,700 people, from Tom Brokaw to Tom Daschle, are taking the powerful drug as a prophylactic against possible anthrax infection.
In addition, the drug is now being dispensed to more than 10,000 postal workers in New Jersey, Washington and Baltimore, who might have been exposed to spores.
Even the crew of a Mississippi towboat are popping the pills after being dusted Friday with a mysterious chemical by a low-flying plane.
That doesn't include the tens of thousands of Americans living primarily in New York, Washington and Florida who have stockpiled Cipro and may be taking it even though they haven't been in buildings where anthrax-laced mail has been handled or opened.
For them, the drug is more of an anti-anxiety medication.
It's hard to predict how these uninfected and otherwise healthy individuals will react to taking two 500-mg tablets of the powerful antimicrobial every day for two months.
But doctors say the likelihood of side effects increases the longer patients stay on antibiotics.
And Cipro is one drug that patients do not want to stay on longer than they have to.
Studies show it can lead to chronic stomach problems, such as colitis, connective tissue damage, including torn Achilles' tendons, and even brain damage.
It's not candy, yet people are popping the white pills as if they were Tic-Tacs.
In fact, Cipro, part of the fluoroquinolone family of antibiotics, is the most powerful germ-killer, which is why the U.S. military stockpiles it for possible germ warfare.
It acts much like a defoliant wiping out the targeted bad bacteria, such as anthrax, but also the good bacteria in your body.
That's why Cipro patients commonly vomit or get diarrhea.
The potent antimicrobial kills the so-called "normal flora" in the digestive tract that help keep unwanted bugs in check, doctors say.
When they're destroyed, unwanted yeast or other bacteria may take over, causing stomach upset.
(Pharmacists recommend taking Cipro on an empty stomach to maximize its absorption, which only exacerbates the gastrointestinal reaction.
Taking the drug with lots of water, however, may help ease digestion.)
Cipro also is known to adversely affect the central nervous system, causing drowsiness, dizziness, irritability, insomnia, restlessness and headaches.
In rarer cases, Cipro can cause hallucinations and even seizures.
It can also weaken cartilage and cause joint damage.
Those at greatest risk of suffering side effects from Cipro include:
- Runners, weight-lifters, or any athletes or workers who put a lot of pressure and strain on their joints;
- tea and coffee drinkers;
- small children;
- expectant mothers;
- The elderly, or anyone with weakened immune systems;
- heavy alcohol drinkers, or those with a history of liver problems;
- diabetics.
Cipro weakens tendons which, in rare cases, can rupture under physical stress and require surgery and months of rehabilitation.
Tendons subjected to heavy stress such as the Achilles' tendon, shoulder rotator cuff, and those supporting the knee and attached to the quadriceps muscles are most at risk of tearing, according to New York orthopedic surgeon Dr. Riley Williams in a 1999 New York Times interview.
The injury typically occurs near the end of a 7- or 14-day course of treatment, he says, or even after the course has been completed.
Bayer AG, the German firm which manufacturers Cipro, argues that of the more than 100 million Cipro prescriptions written in the U.S. between 1989 and 1999, only 100 cases of tendon ruptures were reported in medical journals.
Of course, the effects of Cipro on tendons following a 60-day dosage have not yet been studied.
Cipro can dramatically intensify the metabolic effects of caffeine by increasing the level of theophylline alkaloids in the bloodstream.
In fact, Cipro can cause "theophylline-induced toxicity," noted Dr. Richard A. Gleckman of the Boston University School of Medicine.
While the FDA approved Cipro for sale here in 1987, it still has not OK'd its use for children under 18.
Reason: The antimicrobial may, according to tests on immature animals and a small number of reported cases in children, cause arthropathy joint and cartilage damage that leads to walking difficulties.
Some doctors still prescribe Cipro for children with infections that other antibiotics can't kill, such as bacterial meningitis.
And some will give Cipro to kids with chronic ear infections, but in the form of ear drops, which aren't as readily absorbed by the body as tablets.
The Centers for Disease Control and Prevention has, however, approved Cipro for kids exposed to, or infected by, anthrax.
For example, a 7-month-old New York infant with cutaneous anthrax is taking Cipro.
So are some children of National Enquirer editors and other staffers employed by American Media Inc.
in Boca Raton, Fla., where an anthrax-laced letter was opened by a photographer, who wound up dying from pulmonary anthrax.
AMI's chief executive encouraged staffers to bring their kids to work, since many of them work long hours.
(The tabloid publisher in January moved its editorial offices to Boca Raton from Lantana, Fla.
The new building is now a Superfund clean-up site.)
Cipro generally is not recommended during pregnancy because of the drug's known association with arthropathy in adolescent animals, as well as small numbers of children.
"Animal studies have discovered no evidence of teratogenicity [a chemical-related disease causing malformed fetuses] related to ciprofloxacin, but no controlled studies of ciprofloxacin in pregnant women have been conducted," a recent JAMA report states.
Even Bayer admits that "the safety of ciprofloxacin in children, adolescents, pregnant women and lactating women has not been established."
There have been cases reported of older patients, in particular, succumbing to neurological abnormalities while taking Cipro.
One man, 70, showed up at an emergency room dizzy, confused and agitated.
He also had developed a gait which he could not correct.
The man had been taking Cipro for an infected wound for weeks.
Tests showed his prescription was the culprit.
Central nervous system toxicity can also take the form of seizures.
In one 1990 study, "ciprofloxacin showed moderate to marked epileptogenic effects."
Cipro elevates liver and kidney enzymes and can lead to jaundice in rare cases.
A 21-year-old British man, for example, took Cipro in 1997 for a bad cough.
A heterosexual teetotaler, he had no history of liver problems.
Yet he had developed jaundice and a tender liver.
His liver function tests returned to normal after discontinuing the antibiotic.
According to the FDA package insert, Cipro is contraindicated for patients with diabetes since it elevates glucose levels.
Diabetics have gone into comas after taking Cipro.
Three years ago, a Washington-area woman took Cipro for a sinus infection, moreover, and spent the next 18 months trying to recover from the drug's side effects, warns one pharmacist here, who's filled so many Cipro prescriptions recently he's run out of stock.
With three Americans dead so far from inhaling anthrax spores sent through the mail, the threat from anthrax terrorism is real (although it still hasn't risen anywhere near the level of a mass attack).
And the thousands of precautionary Cipro prescriptions that have been written may just save thousands of lives.
But they may just as easily make thousands of otherwise healthy people unnecessarily sick.
Indeed, over the coming months, we may be hearing of a new health scare the Cipro syndrome.
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