FDA Requires Antibiotic Cipro to Carry Boxed Warning Cautioning Consumers about Risk of Tendon Ruptures
July 2008 – the FDA this month issued a health alert requiring Cipro’s manufacturer, and the makers of similar antibiotics called fluoroquinolones, to add a warning to the antibiotics’ prescribing information about the increased risk of developing tendonitis and tendon rupture in patients taking fluoroquinolones. The FDA also asked drug companies to provide patients with a Medication Guide that describes these potential Cipro side effects.
Antibiotics That Could Cause Tendon Ruptures
Besides Cipro, the following antibiotics will now have to carry a black box warning about the risks of tendon injuries and tendon ruptures:
- Penetrex (Enoxacin, made by Aventis)
- Tequin (Gatifloxacin, made by Bristol-Myers Squibb)
- Levaquin (Levofloxacin, made by Ortho-McNeil)
- Maxaquin (Lomefloxacin, made by Unimed)
- Avelox (Moxifloxacin, made by Bayer)
- Noroxin (Norfloxacin, made by Merck)
- Floxin (Ofloxacin, made by Daiichi-Sankyo)
Risk of Tendon Ruptures
Tendons subjected to heavy stress, such as the Achilles’ tendon, shoulder rotator cuff, and tendons supporting the knee and attached to the quadriceps, are most at risk of tendon ruptures. According to the FDA, the risk of developing fluoroquinolone- associated tendonitis or tendon rupture is higher in patients who are over the age of 60, those who are taking steroids, and in kidney, heart, and lung transplant recipients. In addition, runners, weight-lifters, and any athletes or workers who put a lot of pressure and strain on their joints, face an increased risk of suffering from tendon ruptures when taking Cipro.
Symptoms of Tendon Rupture may include:
- pain, swelling, or inflammation in a tendon area
- a snap or pop in a tendon area
- bruising right after an injury in a tendon area
- inability to move the affected area or bear weight
Reports of Tendon Rupture Received by the FDA
Between November 1997 and December 2005, the FDA received reports of 262 cases of tendon ruptures, 258 cases of tendonitis, and 274 cases of other tendon injuries associated with the use of fluoroquinolone antibiotics, with 175 of those occurring since the beginning of 2003. From January 2006 through March 31, 2007 the FDA adverse events database received 74 additional reports of tendon ruptures, for a total of 336 cases of tendon rupture reported since November 1997.
Note: Bernstein Liebhard LLP is no longer accepting Cipro cases.