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Bayer Mum on Tendon Rupture in January Release

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Ottawa, OntarioIn January of this year, Bayer Inc. issued a press release touting the virtues of Avelox in treating Streptococcus pneumonia (SP). After treating 128 million patients worldwide, Avelox had been shown a consistent effectiveness against SP, the latter demonstrating a low resistance to moxifloxacin hydrochloride (Avelox). Given the concern over certain strains of bacteria developing a resistance to antibiotics, one can understand Bayer's bravado.

However, aside from listing the most common Avelox side effects, there is no mention in the January 27 press release with regard to Avelox tendon rupture—a serious adverse reaction that can affect an individual's lifestyle and, in some cases, the capacity to earn income.

Avelox antibiotic carries a back box warning—the strongest warning within the toolbox of the US Food and Drug Administration (FDA)—for Avelox tendonitis. Various advocates for health, including the advocacy group Public Citizen and the Office of the Attorney General of Illinois, went after the FDA to require the black box warning from Bayer for Avelox.

And with good reason. An Avelox tendon injury can impose more than mere frustration over not being able to play tennis any longer. Individuals who perform physical work as part of their daily livelihoods could see their income compromised from an inability to perform their jobs. Seniors who can otherwise function on their own suddenly require assistance from family members just to perform everyday tasks. What's more, the risk of tendon injury is not confined to individuals predisposed to tendon injury (save for people over 60), and risk can extend months after Avelox therapy is stopped.

And yet, no mention of that in the Bayer press release, beyond certain Avelox adverse reactions.

"The most commonly reported adverse events with Avelox are nausea (7 percent), diarrhea (5 percent) and dizziness (3 percent)," states the press release, in part. "It is not recommended in patients with severe hepatic (liver) insufficiency, and should be avoided in patients with hypokalemia (low potassium).

"Avelox should also be avoided in patients with a known prolongation of the QT interval
(lengthening of the heartbeat on an electrocardiogram test) and patients receiving class
IA or class III antiarrhythmic drugs. Cases of fulminant hepatitis (a severe, rapid loss of
liver function) potentially leading to liver failure (including fatal case) have been reported
with Avelox."

The press release references the approval of Avelox by Health Canada in 2000. Doctors praise the antibiotic for quickly treating symptoms and helping move patients efficiently.

"Today, antibiotic resistance is a constant issue when treating patients with lower respiratory tract infections," said Dr. Karl Weiss, Professor of Medicine, Maisonneuve-Rosemont Hospital, Faculty of Medicine, Université de Montréal. "When waiting rooms become crowded during the winter months, it is critical for physicians to prescribe an antibiotic with a proven safety and efficacy track record.

However, with respect to Avelox achilles tendon and other tendon rupture concerns, at what cost?


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