Black Box Warnings now Officially Useless

FDA to Add Warning to Antibiotics –
July 9, 2008; Page B7

WASHINGTON — The U.S. Food and Drug Administration will seek to add strong warnings about the risks of tendon rupture associated with a class of antibiotics used to treat bacterial infections.

The FDA wants to add black-box warnings, the strongest warning the agency issues, to a handful of drugs, including Bayer AG’s Cipro and Johnson & Johnson’s Levaquin. The move comes six months after the consumer group Public Citizen sued the FDA to require the agency to add black-box warnings to the drugs.

Serious reports of tendonitis and tendon rupture continue to increase with use of the drugs, prompting the FDA to ask companies to add the stronger warnings, the FDA said in a posting on its Web site Tuesday. Such ruptures most frequently involves the Achilles tendon, but also include ruptures of the shoulder, hand, biceps, and thumbs.
(emphasis mine)

Black box warnings used to be for very serious, life-threatening problems in drugs.  Now tendonitis and tendon rupture are life threats, or are so serious they warrant a Black Box?  The elevation of known, well-documented drug side effects to Black Box status dilutes its meaning, and will ultimately require the formation of a new class of warnings.

Tendon ruptures aren’t benign.  Neither are infections.  Name me an antibiotic that wouldn’t rate a black box under the criteria used on the flouroquinolones, then wonder at what’s happened to the FDA.


  1. It’s the lawyer effect on drugs. Certain drugs are rendered un-usable because of litigation despite a net good. Should you give a drug to someone without warning them of the risk? Of course not. But when legal ease replaces sound sense we’ve got a problem

  2. (law firm troll) says:

    Hi All –

    Have you taken Levaquin and Cipro? The FDA recently warned consumers about newly disclosed risks to those taking the drugs. Apparently it can cause tendon ruptures in patients – a potentially serious and painful condition.

    I work with a law firm that’s investigating whether doctors and pharmacists did enough to warn patients of the serious risks.

    We have also heard from physical trainers and others that if patients simply knew of the risks, they might opt to reduce physical activities that might cause a rupture while taking these drugs.

    We want to hear from Levaquin and Cipro patients who’ve experienced similar symptoms. Check out our investigation at our firm’s Web site, (removed because trolls shouldn’t be fed), for more information.

  3. Law firm idiot:
    If it is a “newly disclosed risk,” how could doctors and pharmacists have had the time to warn patients about it?
    If you think you’re going to find one of the handful of tendon ruptures actually caused by Levaquin or Cipro by trolling on a blog, you’re badly mistaken.
    It is people like you that ruin the practice of medicine.

    Allen –
    Good point about the black box warnings that I never even considered. It is as if the warnings are like those account control pop-ups on Windows Vista – you see them so often that you just ignore them.
    Except that scumbag attorneys don’t sue you if you dismiss too many Vista warnings.

  4. Possible lack of acknowledgment from the FDA regarding the issue is this class of antibiotics is due to the fact that this class is rather lucrative for the makers of such medications.As expected, the FDA finally did address this issue only when they had to, and failed to consider this issue more immediately, as they are required to do, yet the public health does not seem to be thier authentic focus, and this is unfortunate.

    By the way, with Marcolide antibiotics, do not have patients take a statin with this drug, as this could be quite adverse as well.


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