Some antibiotics overprescribed, effects not widely known
When Dr. J.T. Cooper 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, Cooper 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.
Dr. J.T. Cooper says he and his physicians didn’t know about tendon risks associated with Levaquin.
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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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WHAT YOU CAN DO
• Research your drugs: Learn about side effects and potential drug interactions. Be aware that the drug information stapled to your prescription bag in most cases hasn’t been reviewed by the FDA and may be incomplete or downplay risks. Besides asking your doctor and pharmacist, check out the Public Citizen Health Research Group’s site, www.worstpills.org, for detailed reviews on hundreds of drugs, including more than 200 they say should never be used. Some information requires a $15 annual subscription.
• Report reactions: Both health care professionals and patients can help alert federal regulators to potential side effects by reporting them to the U.S. Food and Drug Administration: www.fda.gov /medwatch/how.htm.
• Sign up for alerts: To subscribe to e-mail alerts from the FDA about medical products, go to www.fda.gov /medwatch/elist.htm.
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Cooper 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, Cooper 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,” Cooper 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. Cooper 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 Cooper, 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.”
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.
Please educate others on the severe and often permanent side effects of quinolone antibiotics.