Antibiotic Levaquin Linked to Tendon Rupture—Boxed Warning to Be Added to Prescribing Information
July 2008–The FDA is notifying manufacturers of fluoroquinolone antimicrobial drugs of the need to add a Boxed Warning to the product labeling regarding the increased risk of tendonitis and tendon rupture in patients taking these drugs. The agency has also requested that manufacturers provide a Medication Guide to patients about possible side effects. The strengthened warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations) and would not apply to fluoroquinolones for topical ophthalmic or optic use (e.g., eye and ear drops)
Signs or Symptoms of Tendon Rupture
Tendons are the areas that connect your muscles to your joints. Tendinitis and tendon rupture most frequently involve the Achilles tendon (back of the ankle), but have also been reported in the rotator cuff (the shoulder), the hand, the biceps, and the thumb. Serious cases of tendon rupture may require surgical repair.
According to the FDA, the risk of developing fluoroquinolone-associated tendonitis and tendon rupture is higher in patients who are over the age of 60, those who are taking sterioids (corticosteroids), and in kidney, heart and lung transplant recipients.
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 to the FDA
Between November 1997 through December 31, 2005, the FDA has received 262 reported cases of tendon ruptures, 258 cases of tendonitis, and 274 cases of other tendon disorders 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 event database received 74 additional reports of tendon ruptures, for a total of 336 cases of tendon rupture reported since November 1997.
Fluoroquinolones are a class of antibiotics used to treat bacterial infections and are marketed under various brand names including:
- levofloxacin (marketed as Levaquin)
- ciprofloxacin (marketed as Cipro and generic ciprofloxacin)
- ciprofloxacin extended release (Cipro XR and Proquin XR)
- moxifloxacin (marketed as Avelox)
- gemifloxacin (marketed as Factive)
- norfloxacin (marketed as Noroxin)
- ofloxacin (marketed as Floxin and generic ofloxacin)
Public Citizen Files Suit to Add “Black-Box” Warning for all Fluoroquinolones
In January 2008 the consumer group Public Citizen filed suit against the FDA to compel the government agency to add adequate warnings about the risk of tendon injury associated with fluoroquinolone antibiotics. The group had petitioned the FDA back in August 2006 to add a “black-box” warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics available in the U.S. The petition also sought an FDA warning letter to doctors and health care providers as well as an FDA-approved medication guide to be dispensed with all filled prescriptions. The current lawsuit, filed in U.S. District Court in D.C. alleges that the FDA’s failure to respond to the petition amounted to an unlawful withholding or unreasonable delay in agency action and sought a court order directing the FDA to act on the August 29, 2006 petition.
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