Citizens of Canada have been alerted to the persistent and debilitating side effects associated with fluoroquinolone antibiotics. In a statement issued last month, Health Canada said it is currently working with drug manufacturers to include information about this “rare but serious risk” to the labels for all fluoroquinolone products marketed in that country.
Every year in Canada, more than 3 million prescriptions are filled for Levaquin and other fluoroquinolone antibiotics. In 2008, Health Canada asked fluoroquinolone manufacturers to place a warning on their product labels regarding a potential for serious tendon ruptures. However, the regulator’s most recent review suggested that these drugs might cause a range of potentially permanent and debilitating side effects, including peripheral neuropathy and central nervous system issues, including anxiety, dizziness and confusion.
“At the time of the review, Health Canada identified 115 reports of persistent and disabling side effects associated with the use of fluoroquinolones. In 78 of these reports, a probable (29 reports) or possible (49 reports) causal link could be made between the use of fluoroquinolones and persistent disability,” the alert stated. “In the remaining cases, there was either not enough information available or it was unlikely that the reports of persistent disability were related to the use of fluoroquinolones.”
Health Canada is now recommending that patients using fluoroquinolones consult their healthcare provider if they experience joint and muscle pain, numbness, tingling or confusion. Patents under consideration for fluoroquinolone treatment should let their provider know if they have previously experienced a side effect to antibiotic treatment.
Last May, the U.S. Food & Drug Administration (FDA) cautioned that fluoroquinolones should not be used to treat sinusitis, bronchitis and uncomplicated UTIs, as their risks generally outweigh their benefits when other treatment options are available. The warning followed an FDA review which also concluded that fluoroquinolone use has the potential to result in multiple and permanent side effects involving the tendons, muscles, joints, nerves and central nervous system.
Court documents indicate that more than 700 product liability claims have been filed in the U.S. District Court, District of Minnesota against the manufacturers of fluoroquinolone antibiotics, including Levaquin, Cipro and Avelox. All of the lawsuits claim that the drugs’ makers downplayed the potential for fluoroquinolones to cause serious nerve damage, and failed to provide doctors and patients with adequate warnings regarding this potentially debilitating side effect.
A number of lawsuits have also been filed in U.S. courts on behalf of individuals who suffered aortic aneurysm and dissection allegedly related to fluoroquinolone treatment.