Avelox Tendon Ruptures

Spokane, WAPatients who took Avelox to treat their bacterial infection might not have been expecting a risk of serious Avelox side effects. Those serious side effects include an increased risk of Avelox tendon rupture. Like other drugs in its class, Avelox now carries a black box warning, alerting patients to serious Avelox adverse reactions.

Avelox is in a class of drugs called flouroquinolones, a class that includes Cipro and Levaquin. Flouroquinolones are used to treat bacterial infections, such as bacterial sinusitis, chronic bronchitis and community-acquired pneumonia. Drugs in the flouroquinolone class have been linked to an increased risk of tendon ruptures and tendon tears.

Most commonly, the Achilles tendon or tendons in the shoulder, hand, bicep or thumb are affected by Avelox-related side effects. Any tendon, however, is at risk of rupture. Although there are some factors that increase the likelihood of a tendon rupture—such as being older than 60, taking corticosteroids, and having received a kidney, heart or lung transplant—tendon rupture has occurred in patients who do not have those risk factors.

Complicating matters is that tendon ruptures have occurred several months after treatment with Avelox is completed.

Patients who take Avelox and have signs of tendon pain, swelling or inflammation are advised by the US Food and Drug Administration (FDA) to stop taking Avelox immediately and seek the help of a healthcare provider.

In 2008, the FDA requested manufacturers of fluoroquinolone drugs, including Avelox, include a boxed warning on the drugs label. That boxed warning was to alert patients to the increased risk of tendinitis and tendon rupture.

"Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations," said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research, in 2008, when the boxed warning was announced. "The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."