Fluoroquinolones, Tendons and the FDA

Some months ago I considered posting about the strange association between quinolone antibiotic use and tendon rupture.  I had seen a case of achilles tendon rupture with a tenuous link to previous antibiotics and wanted to get a better handle on the numbers.  The literature on the subject was, however,  sketchy at best.  I  did come away with the vague notion that the risk with quinolones of tendon rupture was about four to five times the norm, about 10-15/100,000 treated.  This risk increased significantly in patients over sixty, and even more so in corticosteroid treated patients. The whole endeavour was rather unsatisfying though because, aside from the dubious numbers, the  pathophysiology question remained a  complete mystery.  Pathology shows nothing exceptional, no different from your run-of-the-mill tendon damage.  How could an antibiotic snap a tendon within days of treatment.  Anyway, I canned the idea of blogging on the subject until more illuminating data surfaced.

And there it was.  While I was on holiday the FDA announced that all quinolones will now have a boxed warning about the hazards  of tendon damage.  Serious stuff.  Must finally have some solid figures, Cochrane-level evidence,  systematic review or at a minimum, a segment on Oprah...  Nope.  Not a word about new evidence, just ongoing reports. Quite the let-down.  I was rather miffed at this seeming heavy hand with no goods to back it up..  After all, the association is well known.  Why the drama? 

 As I mulled it over, however, I realized that in my own practice, which as a rheumatologist includes many tendon problems, many patients over sixty and many on corticosteroids, I may not have actually given it the concern it deserves.  I've never actually suggested to a 60 year old rheumatoid patient taking steroids that they should take another antibiotic, given a choice.  Maybe I should. Maybe I should discuss it with the microbiologists and respirologists as well. 

So maybe the boxed warning has done it's job, at least on one clinician.  I still don't know though, if this is the way for the FDA to proceed.  Will including tendonitis as a boxed warning issue dilute the  value of this level of concern?  Can they give boxed warnings for any definite, but hardly life-threatening side-effect?  What would be the point.  Maybe a simple FDA statement or warning would suffice.  Maybe repeated warnings over time, with press releases.  Even better, how about a spot on Oprah.

Comments

[An Aud Life]

I found your site to be very interesting, helpful and humorous at times. As an RA sufferer, it's refreshing to see a Rheumatologist's point of view!
Thank you for your dedication in this field.

~Audrey

[3+speckled]

Thanks for the comments. While the blog is actually meant for rheumatologists, it's always interesting and enlightening to hear from those who actually suffer from these diseases. Feel free to comment frankly, and I'll do the same. That's something we often have trouble with, face-to-face in the office.

[Opponnainsats]

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