Canadian Regulators Warn of Levaquin Side Effects
Canadian regulators have issued a new safety warning for Levaquin and other fluoroquinolone antibiotics, after a review identified dozens of serious complications possibly related to their use. The prescribing information for all fluoroquinolones marketed in Canada is now being revised to include information about these risks.
According to an alert issued on January 23rd, Health Canada’s review uncovered 115 reports of “persistent and disabling” side effects among patients treated with fluoroquinolones. These included:
- Tendonitis/tendinopathy (tendon inflammation or disorder)
- Peripheral neuropathy (damage to or disorder affecting the nerves outside the spinal cord and brain)
- Central nervous system disorders (related to disorders of the brain)
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. These side effects can occur hours to weeks after exposure to the antibiotics.
Health Canada is now advising patients to inform their healthcare professional if they previously experienced a side effect that could be related to fluoroquinolone use. They should also consult their provider if they experience serious adverse events during treatment including:
- Joint and muscle pain
- Swelling or rupture of a tendon
- Tingling, numbness, weakness, or other alterations of sensation,
- Suicidal thoughts.
Fluoroquinolones should not be prescribed to patients who have previously experienced serious adverse reactions to these drugs. Health Canada has also asked doctors to consider the potential for disabling and persistent serious adverse events when choosing to prescribe a fluoroquinolone. Treatment with fluoroquinolones should be stopped if a patient experiences an adverse reaction.
FDA Fluoroquinolone Warnings
Fluoroquinolone antibiotics, including Levaquin, Cipro and Avelox, are indicated to treat bacterial infections ranging from pneumonia to anthrax. In August 2013, the U.S. Food & Drug Administration (FDA) required fluoroquinolone manufacturers to strengthen peripheral neuropathy warnings included on their product labels. The modifications were ordered after the agency determined the previous wording did not adequately describe the rapid onset of peripheral neuropathy symptoms, or the fact that nerve damage associated with the antibiotics could be permanent.
Last May, the FDA advised that fluoroquinolones should not be used to treat sinusitis, bronchitis and uncomplicated urinary tract infections, after a new review confirmed that the antibiotics can cause potentially debilitating and permanent side effects. The drugs’ U.S. labels were updated with a Black Box warning to reflect these risks.
Hundreds of fluoroquinolone lawsuits have been filed against the manufacturers of Levaquin, Cipro and Avelox by individuals who allegedly developed peripheral neuropathy due to their use. Bernstein Liebhard LLP is actively filing claims in this litigation, and our attorneys continue to evaluate potential claims. If you would like to discuss filing a similar lawsuit, please call 877-779-1414 today.