Once again, in an attempt to show strength in its ability to protect the public, the FDA shows its weakness by caving to Public Citizen (a group that clearly hates the pharmaceutical industry) by placing a boxed warning on fluroquinolone antibiotics like Cipro and Levaquin.
What's the concern?
According to the FDA:
"Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy."
Tendinitis and tendon rupture are usually associated with sports injuries with younger people. The mechanism by which these antibiotics cause tendon problems remains a mystery.
How serious is this?
On the one hand, these problems are not life threatening. However, they can cause severe pain and disability. As far as warnings go; however, a boxed warning is a pretty serious warning. I have posted previously on the FDA's different levels of warnings. (Note: There is no such thing as a "Black Box", it is a boxed warning. The "black" is something scary the media added). Tendon rupture had been mentioned in these antibiotic's label as an adverse event, so by adding the boxed warning, the FDA is stating this is a greater concern.
So if the problem is serious, why is the warning a bad thing?
According to the Washington Post, The FDA's action came after the consumer group Public Citizen petitioned and later sued the agency for such warnings. Public Citizen's review of the adverse events from November 1997 through Dec. 31, 2005 showed 262 reported cases of tendon ruptures, 258 cases of tendinitis, and 274 cases of other tendon disorders. This is a ridiculously low number if one considers the millions and millions of prescriptions that have been written for quinolone antibiotics such as Cipro. The FDA stated it had recently done its own "new" analysis, which is why it added the boxed warning. However, they do not present the details of their findings. To me, this implies that they simply caved from public pressure and/or from law suit threats. This is a problem, because so many patients who have or will have taken these medications will be needlessly worried. Even worse, some patients might simply stop taking their antibiotics. Finally, further hype regarding drug dangers continues to create an unnecessary fear about medications among the public. This is evident with publications like the "8 drugs doctors would never take" which I previously blogged about, later showing that when you asked real doctors, they completely disagreed (I will follow up on this post shortly).
In my opinion, the FDA showed similar weakness in response to the Avandia hype. As I have blogged previously, based on data they had at the time, and even more recent data, the risk of heart attacks and Avandia just doesn't seem to be true. Yet, the FDA changed its label, scaring and confusing patients and physicians. (The recent recommendations about approval of future diabetes drugs are similar actions).
One thing that shouldn't be overlooked is that despite my opinion that the boxed warning is likely unnecessary and unhelpful, quinolone antibiotics are over-prescribed. A once powerful drug, many bacteria are now resistant to Cipro because of over-use. Newer generations of fluroquinolones are likely similarly over-prescribes (as are antibiotics in general). That said, there are some conditions mild (uncomplicated urinary tract infections) and more serious (pneumonia) where therapy is appropriate. In those cases, these medications should be used. The boxed warning should be taken into consideration (consider alternatives for elderly and immunosuppressed patients and/or warn appropriately), but for the general public, tendinitis and tendon rupture was so rare, even by Public Citizen's numbers, that this should still be considered a rare adverse event.