"The numbers are startling. Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of early warning signals, such as the onset of tendon pain, and switched to other antibiotics," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "The FDA must act and require black box warnings and patient information guides."

Public Citizen's review of the FDA's adverse event database shows 262 reported cases of tendon ruptures, 258 cases of tendonitis and 274 cases of other tendon disorders between November 1997 and Dec. 31, 2005, associated with the fluoroquinolone antibiotics, with 175 of those occurring since the beginning of 2003.

Sixty-one percent of the ruptures were associated with Levaquin, which has accounted for 45 percent of all fluoroquinolone prescriptions in the past four years, while 23 percent of the ruptures were associated with Cipro.

One theory is that fluoroquinolones are toxic to tendon fibers and may decrease blood supply in tendons that already have a limited blood supply.

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Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated and needing extensive surgery.

The Food and Drug Administration ordered makers of fluoroquinolone drugs -- a potent class of antibacterials -- to add a prominent "black box'' warning to their products and develop new literature for patients emphasizing the risks.

The FDA's action came after the consumer group Public Citizen petitioned -- and later sued -- the agency for such warnings. Regulators took too long to act, complained Sidney Wolfe, head of the consumer group's health section. Many injuries "would have been prevented if patients and doctors had known a pain in the tendon is an early sign that leads to rupture,'' Wolfe said. Public Citizen's original petition was filed nearly two years ago.

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The FDA also issued Information for Health Care Professionals today to alert health care professionals to the increased risk of tendinitis and tendon rupture in patients taking these drugs.

Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy.

The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin

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Cipro is one of the strongest antibiotics around and it did know out my respiratory infection when I took it, but three months later, I could hardly walk.  All of my joints became inflamed and I even went to the ER, I was so scared.  They asked me if I had taken anything recently and I told them that three months before this, I had taken Cipro and they told me I had a delayed bad reaction to it, which made me feel like I was becoming crippled.  The ER gave me a shot right away and a prescription for something and then I was okay.