As one of the most popular antibiotics in the United States, Zithromax has been at the center of praise and controversy for years.

Despite the drug’s overwhelming success in the patient population and medical community, there is also significant concern over the devastating side effects Zithromax can induce, particularly the skin reaction Stevens Johnson Syndrome.

The Food and Drug Administration (FDA) sent a warning letter to Pfizer in June 2012, regarding Zithromax-extension advertisement, stating that the brochure did not adequately describe the drug’s side effects.

In particular, the federal agency complained that the brochure and the Zithromax label did not sufficiently describe the some of the severe complications associated with the drug such as Stevens Johnson Syndrome.

What is Stevens Johnson Syndrome?

Stevens Johnson Syndrome (SJS) is an extremely rare allergic skin reaction, which is characterized by the red or purple skin lesions that appear on the patient’s skin. These infected skin areas soon detach, exposing muscle and tissue to potential infection and other complications.

SJS can cause a number of permanent injuries including blindness, skin scarring, organ damage, and even death. Stevens Johnson Syndrome is specifically caused by an adverse reaction to medications like Zithromax, but experts are unsure why only certain patients are struck and what drugs carry the risk.

Concerns About Zithromax SJS

Over the years, a number of drugs have been indicated to cause Stevens Johnson Syndrome through injury reports, with Zithromax being one of the most common drugs mentioned.

In one example, in 2009, parents of a young girl were shocked to witness their daughter develop Stevens Johnson Syndrome soon after starting Zithromax.

Luckily, the child survived and was hospitalized for weeks to treat the symptoms. The parents filed a Zithromax SJS lawsuit against Pfizer in August 2012, two months after the FDA sent that warning letter to Pfizer.

Ultimately, the parents claimed that if they had known the risk of Zithromax SJS, then they never would have agreed to let their daughter take the drug.

Zithromax is highly popular among parents and pediatric patients due to its short prescription regime of five days, compared to the standard ten with other antibiotics.

Zithromax Lacks Sufficient SJS Warning

While Stevens Johnson Syndrome is an extremly rare condition, with only 300 patients diagnosed per year, experts state that medications should clearly address the risk of Stevens Johnson Syndrome if patients have indicated SJS symptoms.

The FDA concurs with this concern, which led the agency to order Pfizer to properly address the SJS concern.

However, according to the official Pfizer website, the severity of Zithromax SJS is only addressed under the header “For Health Care Professionals: Zithromax US Physician Prescribing Information”.

This warning was added on May 20, 2014, is an extensive file that detailed information for doctors and other healthcare professionals. Only in this section, is Zithromax SJS mentioned and discussed to a certain extent. The warning stated cases of Zithromax SJS have been reported and fatalities have occurred.

However, this condition is addressed nowhere in the consumer pages for Zithromax, only that the drug can possibly induce allergic reactions.

It is vital for pharmaceutical companies to mention Stevens Johnson Syndrome as a potential risk, if their drugs could possibly cause it.

Former Zithromax patients who suffered Stevens Johnson Syndrome, could potentially seek compensatory damages from Pfizer for failing to protect them against the defects of their product.