July 8, 2008—After receiving hundreds of reports of tendon ruptures following use of Levaquin, the FDA announced it would require the drug to contact a black box warning to alert patients to the risk. A black box warning is the strongest warning available to the FDA and underscores the serious side effects of Levaquin.
Levaquin belongs to a class of antibiotics known as fluoroquinolones. Prior to the FDA announcement, the agency received more than 400 reports of tendon ruptures following use of fluoroquinolones, including Levaquin. Data indicated that the risk of tendon rupture increased by three to four times when taking Levaquin.
Public Citizen, a consumer health group, requested the FDA place a black box warning on Levaquin in August 2006. After the agency failed to take such a step, Public Citizen filed a lawsuit in 2008 that asked for the FDA to be forced to issue such a warning.
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