Antibiotics - Levaquin, etc

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SPOTLIGHT: WATCHING OUT FOR YOUR SAFETY AND POCKETBOOK

Antibiotics’ dangers not widely known

By _Alison Young_ (mailto:spotlight@...)

The Atlanta Journal-Constitution

Sunday, January 04, 2009

When Dr. J.T. hobbles around his Marietta medical office, the boot

brace on his right foot is a reminder of a danger posed by some of the most

popular —- and misprescribed —- antibiotics on the market.

Like thousands of others who have taken Levaquin, Cipro and other

fluoroquinolone antibiotics, suffered a near-rupture of his Achilles

tendon.

Tendon side effects have been reported for at least 20 years, but drug makers

only began sending letters to doctors warning them of the problem in recent

months.

said he’d never heard about the risk until his foot swelled up

painfully in September while he was taking Levaquin for pneumonia. Neither had

his

doctors, said, and he worries that many still don’t know about it.

“The best defense is for the patient to know,†he said.

In 2007, U.S. patients received more than 40 million prescriptions for

fluoroquinolone antibiotics, according to IMS Health, a health care information

company. Some studies have found these drugs are often misprescribed, chosen

first by doctors when other antibiotics are more appropriate —- or when none

are

needed.

“At one hospital the nurses told me they call Levaquin ‘Vitamin L’ because

everybody is on it,†said.

While rare, the tendinitis and tendon rupture side effects can be disabling,

making it difficult or impossible to use the affected limb. In some cases

surgery is required to repair the tendon. said he was hospitalized for

six days and lost two weeks of work. After weeks in the boot brace, he is only

now being allowed brief periods out of it, in a special shoe. It will be the

end of the month before he can start driving again.

The experience, he said, is prompting him to limit prescribing

fluoroquinolones for his patients when other antibiotics will work, and to try

to get the

word out to other doctors and patients.

“I don’t want other people to experience the same thing,†said ,

73.

Last summer, the U.S. Food and Drug Administration told the makers of pill

and injectable fluoroquinolone antibiotics to add to the drugs’ prescribing

information a black-box warning —- the most serious type —- about the

increased

risk of tendinitis and tendon rupture. The agency stopped short of requiring

that drug companies send letters to doctors alerting them of the change,

though a few have done so voluntarily in recent months.

“We wanted to make sure they had all the information they needed in treating

their patients,†said Amy Firsching, a spokeswoman for Ortho-McNeil, which

sells Levaquin.

Bayer HealthCare Pharmaceuticals sent letters in October to doctors about

Cipro and Avelox. Oscient Pharmaceuticals, which sells Factive, said its letters

were to go out by this weekend.

To make sure consumers are better informed, the FDA is requiring that

pharmacists begin providing an agency-approved medication guide to patients

picking

up prescriptions for this class of antibiotics.

The guide, a somewhat rare action for the FDA, details tendon and other

serious side effects such as heart rhythm disorders and nerve problems.

One reason for the new warnings was a lawsuit by Public Citizen’s Health

Research Group against the FDA last January. The suit alleged the FDA was

dragging its feet taking action on the group’s August 2006 petition for

stronger

warnings about the tendon dangers.

The FDA has received nearly 2,250 reports of tendon disorders and 775 reports

of tendon ruptures among patients taking fluoroquinolones, though the actual

numbers are likely much greater since most side effects are never reported.

“The tendon ruptures are entirely preventable if at the time they start

getting pain they call their doctor and get switched to another drug,†said

Dr.

Sidney Wolfe, director of the Health Research Group at Public Citizen, a

Washington-based watchdog group.

The FDA-approved label, or prescribing information, for this class of

antibiotics has included information about tendon side effects for several

years,

representatives for the drug makers note. But these labels are often 20 or

more pages long and packed with details about the medication’s chemistry,

absorption, approved uses as well as various precautions, warnings and

contraindications.

Until now, the tendon warnings weren’t prominent enough, Wolfe said, adding

that sending warning letters directly to doctors is critical. “If doctors knew

about this, we wouldn’t continue to see this continuing onslaught of tendon

ruptures,†he said.

“The focus of the marketing of drugs is mainly on the benefit side,†Wolfe

said. “Doctors are historically underinformed about the risks of drugs.â€

Not only should patients be on the lookout for any sign of tendon pain, they

should question their doctors about whether they should be taking a

fluoroquinolone antibiotic at all, Wolfe said. His group considers it one of the

most

overprescribed classes of drugs in the nation.

“They are just not the first-choice drugs for many diseases,†Wolfe said.

Researchers at the University of Pennsylvania found that inappropriate use of

fluoroquinolones was “extremely common.†Of 100 consecutive patients

prescribed the class of drugs at two medical center emergency departments, 81

received it for inappropriate conditions.

Why have fluoroquinolones become so popular with doctors? “It’s an

antibiotic that in many ways requires you not to have to do a lot of

thinking,†said

Dr. Ebbing Lautenbach, a co-author of the 2003 study. Because the drugs kill a

broad spectrum of bacteria, he said, a doctor has a good shot at covering

whatever is causing the infection.

While other, older or more targeted antibiotics might be considered the

first-line therapy, he said, doctors may prescribe a fluoroquinolone first in

case the infection is resistant to the older antibiotic.

“It’s a shortsighted way of approaching uncertainty,†said Lautenbach, who

is co-principal investigator at the federally supported Center for Education

and Research on Therapeutics at the University of Pennsylvania.

Lautenbach advises patients to ask their doctors several questions: Do I have

an infection? What kind of infection do you think I have? Do I really need

an antibiotic?

“Most physicians assume the patient wants an antibiotic,†said Lautenbach,

but they may not need it.

QUINOLONE SALES

………………..2007…………Market

Drug…………….prescriptions ..share

Ciprofloxacin HCL ..19.2 million….47.6%

Levaquin…………15.6 million….38.5%

Avelox…………..4.8 million ….11.8%

Cipro …………..308,000 ………0.8%

Factive …………240,000 ………0.6%

All others……….288,000 ………0.7%

Source: IMS Health

KNOW THE SIDE EFFECTS

All medications have potential side effects. The key, experts say, is

balancing risk with potential benefit.

Antibiotics called fluoroquinolones, sometimes referred to as quinolone

antibiotics, include the brand names Avelox, Cipro, Factive and Levaquin.

Generic

drug names often include “floxacin†as part of their name, such as

ciprofloxacin.

While the U.S. Food and Drug Administration says serious side effects are

rare, here are some to watch for and let your doctor know about immediately:

> Tendon disorders: Beware of any pain, swelling or inflammation of your

tendons. The problems, tendinitis and tendon rupture, most frequently involve

the Achilles’ tendon, which runs along the back of the heel, but also have

been

reported in the shoulder, hand and other tendons. The side effect can happen

while the patient is taking the antibiotic —- or even several months after

completing treatment, the FDA said. The risk is further increased in patients

older than 60, in those also taking corticosteroids, and in recipients of

kidney, heart and lung transplants.

> Heart problems: Serious heart rhythm problems, called a prolonged QT

interval, can be caused by drugs in this class. Elderly patients and those who

take certain drugs to control heart rhythm are among those at special risk.

> Dangerous diarrhea: These antibiotics can cause a serious intestine

infection characterized by persistent or watery diarrhea. It can occur two

months

or more after patients finish taking the pills. While the side effect can

occur with most types of antibiotics, some studies indicate fluoroquinolones may

pose a higher risk.

> Nerve problems: Damage to nerves in the arms, hands, legs or feet can be

caused by these drugs, causing numbness, weakness, burning and tingling.

> Others: Seizures, hallucinations, depression, light sensitivity, as well

as damage to the liver, kidneys or bone marrow, and changes in blood sugar.

Source: FDA-approved drug labels and medication guides, AJC research

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