The Two Faces of Avelox

August 26, 2009. By Gordon Gibb

Washington, DC: The Avelox antibiotic and related Avelox side effects—tendon rupture among them—is yet another example of the prescription drug culture we find ourselves in today. Drugs are designed to do incredible things, such as eradicate serious bacterial infections. However in so doing, they can also create irreparable harm and the manufacturers know well the risks involved.

Tendon RuptureIt says so right on the medication information.

On the official Avelox website, the viewer is welcomed with reassuring words as to the effectiveness of Avelox (moxifloxacin hydrochloride) as a highly-active antibiotic effective against many different strains of bacteria. The web site home page goes on to describe how Avelox has a “well-characterized safety profile, which has been studied in over 14,000 patients in clinical trials and 92,000 patients in post marketing surveillance studies. Furthermore Avelox has been used to treat over 117 million patients worldwide.”

Important safety information for patients as well as health care professionals can be found inside a red box. Among the three choices is a link to the ‘Dear Health Care Professional’ letter relating to the request in October of last year by the US Food and Drug Administration (FDA) that Avelox be outfitted with a black box warning for tendonitis and tendon rupture.

“Fluoroquinolones, including Avelox (is) associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.”

The reference to tendonitis and tendon rupture is also found in the Avelox Medication Guide for patients, to which web surfers viewing the official Avelox home page can link.

Below the introductory paragraph in the pdf version of the medication guide is the header: ‘What is the most important information I should know about Avelox?’

And here it is:

“Avelox belongs to a class of antibiotics called fluoroquinolones. Avelox can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take Avelox.”

Such is the reality of the modern pharmaceutical drug culture. Powerful drugs that are developed to fight serious disease and help Americans live longer, can also be harmful. They can even kill. And yet such drugs continue to be legitimately available so long as sufficient warnings are provided and the FDA can retain the view that benefits outweigh the risks.

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One Response to “Avelox”

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