Earlier this year the U.S. Food & Drug Administration (FDA) warned that, Cipro, Levaquin and other fluoroquinolone antibiotics have been linked to ruptured tendons. In July, the agency said it had asked the manufacturers of Cipro, Levaquin and other fluoroquinolones to update their labels with a black box warning regarding the risk of tendon damage. A black box is the FDA’s strongest safety warning.
In addition to Cipro and Levaquin, other fluoroquinolone antibiotics include Cipro XR, Proquin XR, Factive, Avelox, Noroxin, Floxin and generic ofloxacin. Fluoroquinolones are antimicrobials, medicines used to treat infections caused by microorganisms. They are used to treat bone and joint infections, skin infections, urinary tract infections, inflammation of the prostate, serious ear infections, bronchitis, pneumonia, tuberculosis, some sexually transmitted diseases (STDs), and some infections that affect people with AIDS.
The first fluoroquinolone was introduced in 1986, but they are really modified quinolones, a class of antibiotics discovered in the early 1960s. Critics of these drugs allege that fluoroquinolone antibiotics were developed and put on the fast track to FDA approval without the benefit of adequate premarket testing to accurately determine the probability of certain side effects within the general population. After gaining FDA approval, the new fluoroquinolone antibiotics were aggressively marketed by the manufacturers.
After the 2001 anthrax attacks, many Americans became familiar with Cipro. At the time, Cipro gained notoriety as the only drug approved for the prevention and treatment of inhalation anthrax. However, since then doxycycline has also been approved for anthrax prevention, and doxycycline and amoxicillin have been approved to treat the disease.
The tendon issues associated with Cipro and Levaquin and the other fluoroquinolones have been known for some time. Despite the urgency of the FDAs July fluoroquinolone warning, the agency had actually taken its time in issuing the alert. In fact, the alert might have been prompted by a lawsuit.
In January 2008, the consumer advocacy group Public Citizen filed a lawsuit against the FDA in an attempt to compel the agency to act on a petition filed it filed 16 months prior requesting that new warnings be added about side effects of Cipro, Levaquin and other antibiotics. At the time of the filing, Public Citizen said the FDA had received reports of at least 336 individuals who experienced a tendon rupture after using such drugs.
The tendon ruptures related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs. Tendons are the areas that connect the muscles to your joints. According to the FDA alert, the risk of tendonitis and tendon rupture linked to drugs such as Cipro and Levaquin is “especially increased” in patients older than 60, as well as those who have received kidney, heart, or lung transplants and people on “concomitantâ€? steroid therapy.
The FDA also warned that physicians “should advise patients, at the first sign of tendon pain, swelling, or inflammation�”symptoms that typically precede tendon rupture and tendonitis�”to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.â€?
Tendon ruptures are not the only side effect associated with Cipro, Levaquin and other fluoroquinolones antibiotics. Patients taking one of these antibiotics should contact their doctors if they experience any of these symptoms:
swelling of the face and throat problems swallowing shortness of breath rapid heartbeat tingling in the fingers or toes itching or hives loss of consciousness
In May 2005, a warning was added to the label of Cipro regarding its association to Toxic Epidermal Necrolysis (TEN). TEN – also called Lyle’s Syndrome – is a life-threatening skin condition that is frequently induced by a reaction to medications. Patients with the disorder should be hospitalized, often in an intensive care unit. In some situations patients may be treated in a burn unit.
Levaquin has been linked to blood sugar problems, liver disorders and peripheral neuropathy. People with peripheral neuropathy may experience temporary numbness, tingling, and pricking sensations, sensitivity to touch, or muscle weakness. Others may suffer more extreme symptoms, including burning pain (especially at night), muscle wasting, paralysis, or organ or gland dysfunction. In the most extreme cases, breathing may become difficult or organ failure may occur. Peripheral neuropathy can become permanent, so Levaquin should be discontinued immediately if any symptoms of this disorder appear during treatment.
In 2004 new warning labels were added to all of the fluoroquinolones regarding peripheral neuropathy (irreversible nerve damage), heart problems (prolonged QT Interval / Torsades de pointes), pseudomembranous colitis, rhabdomyolysis (muscle wasting) and Steven Johnson Syndrome. Fluoroquinolones have also caused fetal harm in animal studies, including decreased body weights and malformed bones as well as an increased risk of death. Because of the potential for serious adverse effects to the fetus, these drugs should not be used by pregnant women.
Pittsburgh-based freelance writer
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