July 8, 2008—The FDA announced that it would require a Black Box Warning on Levaquin to inform patients of the risk of tendon rupture. A black box warning is the most serious leveled by the FDA and is reserved for those drugs that carry a significant risk of serious adverse effects.
The FDA warned that pain, swelling, inflammation and tears of tendons including the Achilles, shoulder, hand or other tendons can occur in patients taking Levaquin. The risk is greatest in patients who are over the age of 60, recipients of heart, kidney or lung transplants and patients utilizing concomitant steroid therapy. |