Is Cipro

Wednesday, October 24, 2001

BIOLOGICAL WAR-FEAR

Saved from anthrax, sick from Cipro?

Side effects could hit runners, coffee-drinkers, kids, elderly hardest

By Paul Sperry

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.

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;

And, diabetics.

Runners:

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.

Tea and coffee drinkers:

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.

Children:

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.)

Expectant mothers:

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 [achemical-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."

Elderly:

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."

Heavy drinkers:

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.

Diabetics:

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.