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July 14th, 2008

Cipro Finally Gets Black Box on Tendon Ruptures

Cipro and other similar antibiotics will finally bear black box warnings about their association for tendon damage. The Food & Drug Administration (FDA) said last week it decision to ask for the black boxes was made because reports of tendonitis and tendon rupture associated with Cipro use are on the rise.

According to the FDA, tendon ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs. Tendons are the areas that connect your muscles to your joints. The Achilles tendon is at the back of the ankle. The risk of tendonitis and tendon rupture linked to drugs such as Cipro is “especially increased” in patients older than 60, as well as those who have received kidney, heart, or lung transplants and people on “concomitant” steroid therapy.

The FDA warns that physicians “should advise patients, at the first sign of tendon pain, swelling, or inflammation—symptoms that typically precede tendon rupture and tendonitis—to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.”

Other antibiotics that will now bear a similar black box warning include gemifloxacin, marketed as Factive; levofloxacin, marketed as Levaquin; moxifloxacin, marketed as Avelox; norfloxacin, marketed as Noroxin; and ofloxacin, marketed as Floxin and generic ofloxacin.

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