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Levaquin Upgraded to Black Box Warning

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Washington, DC: On July 8, 2008 the FDA announced that Levaquin will get a black box warning on all fluoroquinolone antibiotics because of an increased risk for tendonitis and tendon rupture. The consumer group Public Citizen first petitioned the agency and then sued to get the warning issued.

Antibiotic WarningLevaquin (also known as levofloxacin) is a synthetic antibiotic manufactured by Ortho-McNeil, a subsidiary of Johnson & Johnson, and is prescribed to fight infections, including bronchitis, pneumonia, Chlamydia, gonorrhea, skin infections, urinary tract infections, etc. The black box warning given to Levaquin and other drugs in the fluoroquinolones group is intended to ensure physicians and patients understand the increased risks involved and the potential for adverse events, particularly tendon ruptures.

It is not yet understood why these drugs would raise the risk of tendon injuries, an atypical adverse reaction to an antibiotic. Tendons are cords of tissue that join muscles and bones, and are essential in movement. The most common kind of rupture reported to the FDA involved the Achilles tendon in the heel, but some injuries also involved the rotator cuff in the shoulder, and tendons in the hands, biceps, and even the thumb.

In 2003, The Journal of the American Board of Family Practice reported on the increasingly popular fluoroquinolone class of antibiotics that subsequently led to "widespread and indiscriminate use" of Levaquin. The study also reported cases of tendon rupture in association with newer quinolones such as levofloxacin that went back to 1983. According to the study, patients who had taken the drug at any time, even two years or prior, may be at an increased risk for tendonitis. Patients most at risk are people over 60, those with kidney, heart and lung transplants, and those also taking steroids.

Yet the agency approved the drug as an antibiotic for children just a few years after this report was published.

In October 1996, the FDA first issued a Report of Adverse Events and revised the class labeling for fluoroquinolones to include a warning of possible tendonitis/tendon rupture after more than 200 reports of quinolone-related tendonopathy over a 10-year period.

With the increased use of levofloxacin and other quinolone antibiotics, experts in the medical community expect to see a substantial rise in tendon ruptures. Tendonitis is characteristically accompanied by a sharp pain and the pain diminishes after tendon rupture occurs.

Most drug-related tendon ruptures occur after two weeks of therapy, although they can also occur as early as a few hours after the initial dose or up to six months after treatment. A diagnosis is usually confirmed by ultrasound or more precisely by an MRI. Treatment begins with immediately discontinuing Levaquin and any other quinolone antibiotics.

In this black box warning, FDA officials stress that many of the serious injuries appeared to be preventable if patients stopped taking the drugs at the first sign of pain or swelling in a tendon. Patients are advised to then contact their doctor and arrange to switch to an alternative antibiotic. Tendon rupture requires casting and prolonged rest—anywhere from six weeks to six months—which is clearly a serious injury for anyone. You may also want to seek legal advice.

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