Antibiotics side effects

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.

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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.

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21 Responses to “Antibiotics side effects”

  1. Gary says:

    The FDA states that serious adverse drug reactions (ADR’s) to the class of antibiotics known as Fluoroquinolones (FQ) are rare. They also state that tendon ruptures are the main side effect. The FDA is grossly wrong on both counts.

    The FQ’s can cause serious tendon ruptures and tendinitis, but these cases are certainly not rare at all. The FDA claims 1 -2%
    of people are affected, when it is actually closer to 10 – 20%.

    The FQ’s can seriously affect every part of your body and mind.
    Some of the most affected parts are your joints, muscles, eyes,
    nerves, heart and arteries and veins. the list goes on and on.

    The list of serious life altering ADR’s is longer than anyone ever suspected and the magnitude of damage is unappreciated or completely unknown by most all Dr’s. The drug makers have done an excellent job of covering up this ongoing problem to protect their profits.

    You can take these words to the bank, because I have personally lived it and am still living it after 2 1/2 years of
    physical and mental hell brought on by a 10 day scrip of Cipro.

    I have listened to thousands of other people tell their horror
    stories after their ignorant Dr. gave them a FQ for a minor infection. Dr’s don’t want to believe this is possible it seems, as
    they remain in denial for the most part.

    When I asked my Dr. that prescribed me the Cipro to file a report with the FDA for my ADR’s, he flat out refused to do so.
    He denied that it was even remotely possible for Cipro to cause any of my health problems, even though they ALL started the
    last few days of taking my script. Coincidence? I don’t think so.

  2. Bob says:

    I would agree with Gary, if tendon ruptures were the only problem we had to endure i would not be typing this message. Over 50 symptoms, these drugs have given me anxiety, panic disorers,muscle pain, arthritis, nightmares,tendonitis,
    de -personalisation,asthma, vitreous floaters, muscle spasms, nueropathy and the list goes on. I am 1 year out and feel I have aged 20 years after taking Floxin. And all this shit for now diagnosed Non Bacterial Prostatitis, I took the drugs for nothing!!!!!!!!!!

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  4. All I can say is WOW! Most of america doesn’t know any of this and sadly probably doesn’t care. They just want things to be fair. I just don’t believe anyone running for President will do anything different. Once the Big Banks got their hands on the easy money they aren’t going to let it go. Big Business, Big Banks and some Politician-s aren’t Patriotic.-..it’s all about those few who they call shareholde-rs and those politician-s they can buy. America is losing her Greatness.-..when the rich keep getting richer and poor keep getting poorer. When those with money voice speak volumes and those without their voice is just a whisper. GW2 Gold

  5. Flox Fever says:

    FIRST, DO NO HARM! Doctors if you have not read the longest available version of the ADR sheet for each pill you prescribe, you are irresponsible. FIRST, DO NO HARM.

    Ruptured tendons are horrible but one of the LESS unpleasant ADR from quins. Most presenting with quinolone toxicity will be misdiagnosed or written off as hypochondriacs or drug seekers or – I can’t think o the word. Ten years post floxing and I still often forget simple words. Just one of many lasting probably permanent multi system after effects from quins. Quin ADR is especially insidious because some of the ADR are ‘mental’ making the patient seem ‘crazy’ it is actually the toxicity causing it.

    If you care, doctors, develop a treatment for this. Plasmaphoresis? Something? Help them after if you have given this pill at least believe them when it blows the soft tissue in their body apart and refuses to let it heal.

    Or were the animals in the drug studies faking it too?

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