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Levaquin – Labeling Issues

By October 25, 2010July 9th, 2019Uncategorized

Many people question the controversy surrounding labels meant to inform patients about the risks of the medicines they are taking. After all, if the side effects are listed clearly, do the patients have a right to complain that they weren’t informed? Isn’t society at large supposed to understand that people need to read the fine print before committing to anything?

The problem with this argument is that it assumes the labeling is inherently clear and easy to understand. In the case of some medicines, this is not necessarily as cut and dried as “just read the fine print” would imply.

For example, consider the labeling of the powerful antibiotic Levaquin. Considered a big-gun-style medication intended to bring down particularly nasty infections that may not respond to other treatments, Levaquin also is associated with the risk of tendon ruptures. In fact, let’s rephrase that — Levaquin is thoroughly documented as directly causing severe and often crippling tendon ruptures, especially in patients over 65.

Do you see the difference the language makes?

The “black box warning” that the FDA requires on all Levaquin literature says as follows: “Fluoroquinolones, including LEVAQUIN, are associated with increased risk of tendonitis 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 (see Warnings and Precautions 5.1).”

Notice that it mentions tendon ruptures only after bringing up tendonitis. This is an irresponsible word game — the two conditions are not synonymous. Tendonitis is severe soreness requiring rest and anti-inflammatory medicines. Tendon ruptures are potentially crippling and severely painful injuries that often require opiate painkillers. In addition, what does “associated with” mean? It doesn’t seem to make clear that the medicine has been demonstrated by strong evidence to cause this medical condition.

Coupled with the claims of many patients that their doctors prescribed the medicine without telling them clearly of all the risks, this is easily seen as something more serious than a case of consumer neglect.