Zithromax carries the risk of a rare but serious side effect called Stevens Johnson Syndrome. However, even after government regulators implored the drug’s maker to update the warnings, the patient inserts might not adequately convey the risk of this potential side effect.

SJS and Zithromax

Stevens Johnson Syndrome,
or SJS, is a serious autoimmune disease. In Stevens Johnson Syndrome, the immune system misfires and attacks the skin, causing life-threatening sores, blisters, and ulcers all over the body.

The reaction can be fatal, and even survivors may face permanent complications like blindness, disfiguring scars, and organ damage.

Nearly all cases of Stevens Johnson Syndrome can be linked to drug exposures, and azithromycin, sold as Zithromax, is among the drugs that can potentially cause this life-threatening reaction.

The Warning Letter

In 2012, the U.S. Food and Drug Administration (FDA) sent a warning letter to Pfizer, the manufacturer of several formulations of Zithromax, including Zmax and Z-Pak. Among other criticisms, the FDA stated that Pfizer’s inserts for Zithromax did not adequately address the risk of Stevens Johnson Syndrome.

According to the FDA’s warning letter, Pfizer’s insert “minimized the risks associated with Zmax by failing to disclose that severe and fatal allergic skin reactions have been observed with azithromycin.”

While the warning letter’s author acknowledged that the insert advised patients to seek emergency medical treatment if they developed a rash or blisters — the early symptoms of SJS — the FDA felt that this was inadequate and demanded corrective action.

Current Warnings

Several versions of the package insert and prescribing information for Zithromax are available on Pfizer’s website. Like many drugs, there is a version of this information for patients and physicians.

The Zithromax drug information printed for doctors and other medical professionals does mention Stevens Johnson Syndrome by name, and explains how serious this reaction can be.

However, the version of the insert aimed at patients does not mention SJS by name, and is phrased similarly to the passage mentioned in the FDA letter. Arguably, even years after the FDA’s warning, Pfizer’s information for patients might not adequately explain the risk of Stevens Johnson Syndrome.

Legal Action

Zithromax SJS lawsuits have been filed by patients — or in some cases their next of kin — who suffered from Stevens Johnson Syndrome after using Zithromax. These Zithromax lawsuits typically allege that drug makers were aware of the potential risk of Stevens Johnson Syndrome allegedly linked to Zithromax.

Indeed, under federal law, drug makers are legally obligated to monitor post-market reports and medical journals for signs that their drugs are having unexpected side effects like Stevens Johnson Syndrome. These Zithromax SJS lawsuits typically seek to recoup the cost of medical care, lost wages, legal fees, and other costs allegedly stemming from Zithromax SJS.