Zithromax (azithromycin) is a popular antibiotic manufactured by Pfizer. This commonly used antibiotic can lead to Stevens Johnson Syndrome (SJS), which is an allergic skin reaction that leads to severe blistering and inflammation of the mucous membranes.

Patients with SJS sometimes feel as though their skin is being burned from the inside out. When these skin lesions affect more than 30 percent of the body, it is known as Toxic Epidermal Necrolysis (TEN). Not all sufferers survive, and those who do are sometimes left with permanent injuries, such as vision problems, difficulty eating and scarring.

FDA Warns Pfizer About Zithromax SJS Label

Pfizer has been warned by the U.S. Food and Drug Administration (FDA) for failing to adequately warn about the risk of SJS in Zithromax brochures. In a letter dated June 19, 2012, the agency said that the brochure does not discuss the severity of the condition even though the warning label mentions SJS.

The problem is that Pfizer did not explain that SJS can cause large areas of the skin to blister and peel, leading open sores and infection, nor do they explain that in TEN, large areas of the skin can detach from the body and lesions can develop in the mucous membranes. The FDA letter also warned that Pfizer failed to warn about the risk of heart problems associated with Zithromax.

The warning label on Zithromax reads: “Serious allergic reactions, including angioedema, anaphylaxis, Stevens Johnson Syndrome and Toxic Epidermal Necrolysis have been reported rarely in patients on azithromycin therapy using other formulations. Although rare, fatalities have been reported.”

The warning label also says that in some patients, the symptoms of SJS or TEN can come back even though they stop taking the drug. However, the federal agency points out that this information is not included in the brochures.

Study Links Zithromax To SJS

Zithromax side effects reportedly include an increased risk of Zithromax SJS and at least one report has linked Zithromax side effects and the development of Stevens Johnson Syndrome, a potentially fatal condition.

Zithromax has been linked to Steven Johnson Syndrome in one study published in the National Center for Biotechnology Information in 2006. In that study, two cases of Zithromax SJS were discussed, including a 62-year-old woman who took Zithromax for an upper respiratory infection and later developed SJS allegedly as a result of the antibiotic. The woman developed a rash on her hands, fever, chills, and discoloration around her eyes. Luckily, after treatment with corticosteroids, the woman made a full recovery. The other patient who developed SJS after using Zithromax in this study was a child.

Zithromax Lawsuits

There are reportedly thousands of Zithromax lawsuits filed over complications, including the potentially fatal skin reactions Stevens Johnson Syndrome and Toxic Epidermal Necrolysis. Zithromax SJS lawsuits claim the drug manufacturer did not adequately warn about the risk of Zithromax SJS, and some lawsuits have successfully secured compensation for a victim’s ordeal.