Levaquin (levofloxacin), 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 Stevens Johnson Syndrome (SJS) & Toxic Epidermal Necrolysis Syndrome.

What is Levaquin?

Levaquin
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 U.S. Food and Drug Administration (FDA) on Dec. 20, 1996.

As a broad-spectrum fluoroquinolone antibiotic, Levaquin is used against many different bacteria strains such as urinary tract infections, skin infections, or respiratory tract infections.

Broad-spectrum antibiotics effectively combat undetermined life-threatening bacterial infections (such as meningitis) and symptoms caused by multiple concurrent bacterial infections. Levaquin functions by disrupting DNA replication and cell division within bacteria. The drug is expensive and there are many cheaper and more effective antibiotics available.

The first case of Levaquin SJS was reported in 2002. While SJS and TENS are rare, they continue to be reported with levofloxacin use.

Stevens Johnson Syndrome and Toxic Epidermal Necrosis

Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are life-threatening skin conditions that have been associated with fluoroquinolones like Levaquin. SJS and TEN can start with mild non-specific symptoms such as fever, malaise, chills, aching muscles, headache, sore throat or stinging eyes.

In SJS, a person develops blisters in the mucous membranes, typically in the mouth, eyes, and genital areas. With TEN, which is a more severe form of SJS, there is similar blistering of mucous membranes, but the damage is more extensive. The entire epidermis peels off in sheets from large areas of the body.

The mortality rate for persons suffering with Stevens Johnson Syndrome is between 25 percent to 80 percent. Some of the factors that determine a person’s likelihood of survival includes the severity of the disorder and the amount of skin that the victim loses. If a person with SJS has lesions that are exposed and become infected, they have a much higher chance of death.

To save the life of a person with SJS or TEN, treatments usually include intravenous immunoglobulin (IVIG), pain medication, and in the most severe cases, skin grafts. Because SJS and TEN are so dangerous, Levaquin patients and their caregivers must be aware of the Levaquin side effects so that medical attention can be given.

Levaquin SJS Lawsuits

While the association between Levaquin and SJS has been known for many years, Johnson & Johnson has allegedly represented this drug as a safe antibiotic. Given the seriousness of these and other quinolone antibiotics associated with adverse events, the FDA required Ortho McNeil to include a black box warning on Levaquin packaging 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 until July 2009.