As far back as 2012, the U.S. Food and Drug Administration (FDA) has warned Pfizer Inc. that it has not done enough to warn the public about the risk of Zithromax SJS, a painful and sometimes fatal skin reaction.

Stevens Johnson Syndrome, often called SJS, is a life-threatening drug reaction. SJS is an autoimmune reaction, a condition wherein the immune system malfunctions and attacks the patient’s own tissues and organs instead of fighting of an infection. In the case of Zithromax SJS, the body attacks its own skin, the largest organ in the body.

SJS symptoms can easily be mistaken for the flu or any number of other illnesses with fever, chills, and muscle aches. However, hours or days after patients take the drug that triggered their SJS condition, they develop a painful rash accompanied by sores, blisters, and ulcers. In some cases, the damage may spread to the eyes and cause permanent visual damage, or spread to the internal organs and cause organ failure.

When an individual develops SJS, it is considered a medical emergency, and requires intensive treatment and medical monitoring. Even survivors may face lifelong complications like disfiguring, disabling scars, or permanent blindness. While many questions remain about SJS, it is known that nearly all cases are caused by prescription and over-the-counter drugs, and that Zithromax is among a number of drugs known or suspected to trigger SJS in various individuals.

FDA Zithromax SJS Warning and Drug Notice

The FDA sent a warning letter to Pfizer in June 2012, stating that the drug insert for Zithromax (also known as azithromycin and Zmax) did not do enough to warn patients and doctors about the risk of Zithromax SJS. According to the agency’s warning letter, advertising materials for Zithromax dangerously over-promoted the drug while downplaying the potential side effects like Zithromax SJS.

The Zithromax brochure is allegedly false and misleading because it omits and minimizes important risk information, makes unsubstantiated drug superiority claims, omits material facts, broadens the indications for the drug product, makes misleading efficacy claims for Zmax.

Among the specifics of the FDA’s Drug and Safety Communication regarding Zithromax, the FDA stated that the promotional brochure tried to downplay these risks specifically, a sentence warning about SJS ended with the phrase “recurred soon thereafter in some patients without further azithromycin exposure.” The FDA’s warning letter states that this downplays the link between Zithromax and SJS and is misleading. Additionally, although the brochure advised patients to read the drug’s prescribing information for details, the FDA emphatically states this ploy does not absolve them of their duties to fully warn the public of the risk of Zithromax complications like Zithromax SJS.

Under U.S. law, agencies like the FDA are required to routinely monitor advertisements for drugs like Zithromax in order to make sure drug manufacturers are not exaggerating their drugs’ benefits beyond their FDA approved uses.

Zithromax lawsuits have alleged that Pfizer has not done enough to protect the general public from the risk of Zithromax SJS and other possible Zithromax complications. These lawsuits further allege Pfizer aggressively promoted Zithromax, making it a multi-billion dollar blockbuster drug in spite of the risk of Stevens Johnson Syndrome and the FDA’s warnings.