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FDA Requests Black Box on Antibiotics

Posted May 14 2009 4:59pm

FDA Requests Black Box on Antibiotics Warning about Tendon Ruptures

Makers of fluoroquinolone antibiotics are strongly requested
by the U.S. Food and Drug Administration to add a black box warning patients about
the risks of tendon ruptures. …

…The risk of tendon ruptures is “especially increased” in patients older than 60, and those with kidney, heart or lung transplants.

The fluoroquinolone antibiotics targeted by the black box request include ciprofloxacin sold by Bayer A.G. under the brand names Cipro, Ciproxin and Ciprobay, which is effective against both Gram-positive and Gram-negative bacteria. The same class involves levofloxacin sold by Ortho-McNeil under the trade name Levaquin. The drug is usually used in respiratory infections….

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