ALERT: Antibiotic Levaquin Linked to Tendon Rupture
July 2008 — The FDA is notifying manufactures of fluroquinlolone antimicrobial drugs (Levaquin, Cipro and others) that they need to add a Boxed Warning to the product’s labeling that warns consumers of the increased risk of tendonitis and tendon rupture in patients who take these drugs. The FDA also asked drug companies to provide patients with a Medication Guide that describes these potential Levaquin side effects. The strengthened FDA warnings apply to fluoroquinolones for systemic use (e.g., pills, tables, capsules and injectable formulations).
What are the Signs and Symptoms of Tendon Rupture?
Tendons connect your muscles to your joints. Tendinitis and tendon rupture most frequently involve the Achilles tendon (back of your ankle), but have also been repoted in the shoulder (rotar cuff), the hand, the biceps, and the thumb. Serious cases oftendor rupture may require surgical repair.
The FDA reports that 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 steriods (corticosteriods) and in kidney, heart and lung transplant recepients.
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
Patient Reports of Tendon Rupture to 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 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 events database received 74 additional reports of tendon ruptures, for a total of 336 cases of tendon rupture reported since November 1997.
Antibiotics That Could Cause Side Effects Include:
- 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)
- oxfloxacin (marketed as Floxin and generic ofloxacin)
Injured by Levaquin?
Contact Bernstein Liebhard’s exerpienced Levaquin trial attorneys for a free and confidential case evaluation by calling (877) 779-1414 or by clicking here.