Allergic Reaction to Zithromax May Be Stevens Johnson Syndrome

Currently, the warning label for Zithromax only states that some patients may suffer some severe allergic reactions in conjunction with other medications the patients may be taking. However, the warning label does not specifically include Stevens Johnson Syndrome, and the FDA continually criticizes the company for not using the specific title to address the condition.

The biggest criticism from the FDA comes from a letter June 19, 2012 about Pfizer’s “1 Day. 1 Dose” brochure for Zmax, a single-dose version of Zithromax. “The brochure is false or misleading because it omits and minimizes important risk information, makes unsubstantiated superiority claims, omits material facts, broadens the indication for the drug product, makes misleading efficacy claims, and makes unsubstantiated claims for Zmax,” the FDA wrote.

Many medical experts agree with the FDA’s criticism and encourage the idea of a black box warning or the specific warning of Stevens Johnson Syndrome on the label. Pfizer is taking this suggestion into consideration due to the number of lawsuits the company has faced by plaintiffs who developed Stevens Johnson Syndrome after taking Zithromax.

Pfizer is facing charges from plaintiffs all over the United States who accuse the company of manufacturing, distributing, selling and marketing a dangerous product. These charges include negligence, false advertising, misrepresenting a product and concealing information.

Overview of Zithromax Stevens Johnson Syndrome

Until recently, it was unclear as to whether or not Stevens Johnson Syndrome was triggered by medication specifically, or if it was just a part of a severe allergic reaction called erythema multiforme. Erythema multiforme is also caused by medications, but is often a type III hypersensitivity reaction to an infection. Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (TEN), a latent stage of Stevens Johnson Syndrome, are explicitly adverse reactions to medications.

The symptoms of Stevens Johnson Syndrome typically appear within the first two to four weeks after taking the medication. The symptoms of Stevens Johnson Syndrome are blisters, fever, and other flu-like symptoms. Because the symptoms of Stevens Johnson Syndrome are similar to those of burn victims, patients are often treated in burn units. If left untreated, the symptoms can include blindness and in some cases, it can leave a patient permanently debilitated with scars and injuries if not dealt with immediately.

There are approximately 300 new cases of Stevens Johnson Syndrome diagnosed per year, and each case could be a fatality. Due to the severity of the condition, both medical experts and the public take this condition very seriously, and believe that companies should be held responsible if it is not properly mentioned on the medication’s warning label.