Canada Asks for Cipro Tendon Rupture Warning
Just days after federal regulators in the US announced that Cipro and similar antibiotics would bear black box warnings about their risk of tendon damage, Health Canada is asking manufacturers to add the same type of warning to the drugs sold in that country.
Last Tuesday, the US Food & Drug Administration (FDA) asked the makers of fluoroquinolone antibiotics to add the agency’s strictest safety warning to the product labels about their link to tendon damage. The FDA said that patients with the highest risk of problems included people over 60, those with kidney, heart and lung transplants, and those also taking steroids. Most of the tendon ruptures reported to the FDA involved the Achilles tendon. Ruptures of tendons in the rotator cuff, hand, biceps and thumb were also reported.
According to an article by the Associated Press, Health Canada said it will ask manufacturers of fluoroquinolones to include a “box warning” on the product monographs alerting people who take the drugs of the fact they may be at higher risk of tendon ruptures. In an email to the Associated Press spokesperson Alastair Sinclair, said that “tendonitis, tendon disorder, and tendon rupture are known adverse reactions for quinolones.”
In addition to Cipro, the drugs levofloxacin (Levaquin), norfloxacin (Noroxin), ofloxacin (Floxin), gemifloxacin (Factive) and moxifloxacin (Avelox) will be subject to the new Canadian warning.
