Risk of Tendon Ruptures From Common Antibiotic
by Sandra Cassidy
The FDA has received reports of at least 336 individuals who experienced a tendon rupture after using Cipro, Levaquin or one of the floroquinolone antibiotics. Levaquin, known generically as levofloaxcin, is marketed by Ortho-McNeil and is prescribed to treat urinary tract and skin infections, bronchitis and certain types of bacterial infections and pneumonia. Risk of tendon rupture is further increased with concomitant corticosteroid therapy.
The consumer protection group Public Citizen has filed a lawsuit against the FDA seeking stronger warnings about the risk of tendonitis and tendon ruptures from Cipro and Levaquin.
Tendinitis and tendon ruptures induced by fluoroquinolones have been documented in the literature since 1983. Ann. Med. Interna. 2007 May 24 (5): 227-30, Medrano San Ildefonso M. etc. Fluoroquinlone-induced tendon diseases; Arthritis Rheum. 2001 Jun 45 (3) 235-9, van der Linden P.D. etc. Tendon disorders attributed to fluroquinolones: a study on 42 spontaneous reports in the period 1988 to 1998.
Some ruptures are reported to occur after as little as six days after first use of ciprofloxacin. The median duration of fluoroquinolone treatment before the onset of tendon injury was 8 days, although symptoms occurred as early as 2 hours after the first dose and as late as 6 months after treatment was stopped. J. Plas. Reconstr. Aesthet. Surg. 2007 April 2, Akali, etc., Management of bilateral Achilles tendon rupture associated with ciprofloxacin: A review and case presentation. Clin. Infect. Dis. 2003 June 1:36 (11): 1404-10, Khaliq Y. etc. Fluoroquinolone associated teninopathy: a critical review of the literature.
As reported to the World Health Organization Collaborating Centre for Drug Monitoring, 3500 cases of tendon toxicity from fluoroquinolone-associated tendinopathy have been recognized. The most common tendon rupture involves the Achilles tendon, but ruptures can occur in the shoulder, hand or foot. Some researchers speculate that floroquinolones are toxic to tendon fibers and may decrease the blood supply in tendons that already have a limited amount of blood supply. However little is known about the mechanisms behind this adverse reaction. Expert Opin. Drug Saf. 2005 March 4(2):299-309, Melhus, A. Fluoroquinolones and tendon disorders.
The FDA database shows 61% of the tendon ruptures were caused by Levaquin and 23% were caused by Cipro. Public Citizen 's contention that black box warnings could lead to earlier intervention is supported by scientific studies that say the risk merits vigilance for signs of tendonitis Ir. J. Med. Sci. 2001 Jul- Sep 170 (3): 198-9, Butler MW etc. Quinolone- assocaited tendonitis: a problem in COPD?
Public Citizen is also calling for a 'Dear Doctor' letter regarding the stronger warning and patient pamphlets that specifically explain how patients should immediately stop using the drugs if they experience pain or inflammation, precursors to tendon ruptures.
The risk of rupture is significantly increased with corticosteroid use. In one study where up to one-half of patients using Fluoroquinolones experienced tendon rupture, almost one-third had received long-term corticosteroid therapy. Clin. Infect. Dis. 2003 June 1:36 (11): 1404-10, Khaliq Y., Zhanel G.G. Fluoroquinolone associated teninopathy: a critical review of the literature.
Sources
citizen.org August 29, 2006 FDA should warn of tendon ruptures linked to Cipro, Levaquin etc.Public Citizen petitions FDA to Include Black Box Warning
DrugInjury.com; Some Antibiotics Linked to Tendon Rupture
Public Citizen files lawsuit seeking Black Box Warning
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