Washington, DC: Levofloxacin (Levaquin), a fluoroquinolone antibiotic used to treat severe bacterial infections such as urinary tract infections, skin infections and respiratory tract infections, is associated with several serious, if not life-threatening adverse events including but not limited Stevens Johnson Syndrome (SJS) & Toxic Epidermal Necrolysis Syndrome (TENS).
Levofloxacin is produced by Ortho-McNeil, a division of Johnson & Johnson. Sold under various trade names including Levaquin and Tavanic, it was first approved by the Food and Drug Administration (FDA) on December 20, 1996. The first case of levofloxacin-induced TENS was reported in 2002. While SJS/TENS are rare, they continue to be reported with levofloxacin use.
SJS/TENs affect the mucous membranes and the skin. SJS can progress to eventually cause the outer layers of the skin, called the epidermis, to separate from the inner layers of the skin, called the dermis. SJS is also associated with a number of prescription medications as well as some over-the-counter medications.
TENS is closely related to SJS, and has an associated mortality rate of 35 percent, according to the medical literature. TENS is considered a more serious form of SJS, and can result in full separation of the dermis from the epidermis, requiring extensive medical treatment.
Given the seriousness of these and other Levofloxacin associated adverse events, the FDA required Ortho McNeil to include a Levaquin Black Box warning in July 2008. However, while the packaging manufactured during and after September 2008 contains the Black Box Warning, there are reports that old Levaquin packaging does not contain the Black Box label, and that this old packaging was available up to July 2009.
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Last updated on Nov-1-11 |
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