Cipro joins the ‘black box’ club


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The club may not be as elite as it once was -- or perhaps, in an ideal world, should be -- but the Food and Drug Administration has decided Cipro and its ilk deserve to be members.

As such, the class of antibiotics known as fluoroquinolones will now bear a boxed warning, also known as a ‘black box,’ because of reports that the drugs increase the risk of tendinitis and tendon rupture. The FDA has told the manufacturers that the label, the agency’s most serious warning, is necessary to ensure that the drugs’ benefits outweigh the risks. Always a good thing. It’s also told them, while they’re at it, to throw in a medication guide to inform patients of potential side effects.


Most people may remember the drugs from their heady days as simply-must-have protection against a potential anthrax attack. But we’ve all grown older and wiser and less panicked and are now more worried about simply being able to move about the house without hurting something. Says the FDA’s release: ‘The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart and lung transplant recipients.’

The prescribing information already includes warnings about the potential problem, but sifting through that material isn’t easy even for professionals. They’re busy, you understand. And besides, there’s just something about that black box label that tends to give prescribers -- and prescribees -- pause.

If you’ve had problems with the drugs (or any drugs), you can offer your two cents at MedWatch, a more user-friendly way of referring to the FDA Safety Information and Adverse Event Reporting Program. Otherwise, how will anyone know?

For an easy-to-read list of other drugs with black box warnings, go to FormWeb. The information is easier to find than on the government site.

-- Tami Dennis