Zithromax SJS Warnings: Not Much Has Changed

May 21, 2014, 10:30AM. By Gordon Gibb

New York, NYWhen the US Food and Drug Administration (FDA) sent a warning letter to Pfizer in June 2012 with regard to a brochure advertising Zmax (a form of Zithromax, or extended-release azithromycin), the agency expressed concern that marketing materials failed to spell out the severity of Zithromax side effects and, specifically, Stevens Johnson Syndrome.

Zithromax Stevens Johnson Syndrome can, in rare cases, prove fatal. However, plaintiffs in Zithromax rash lawsuits have alleged they were not apprised of the severity of SJS - if they even knew that the debilitating skin problem was even included in the basket of Zithromax reactions.

In 2009, the parents of Aleigh Alexander were surprised as anyone when their daughter developed Zithromax SJS and wound up in the hospital for weeks of treatment. They filed a Zithromax lawsuit in August 2012 - about two months after the FDA took Pfizer to task about not spelling out the potential severity of Stevens Johnson Syndrome in marketing material for Zmax. “As a result of defendants’ respective and collective failure to warn about the serious potentially life-threatening effects [of Zithromax], plaintiff sustained permanent injuries and damages, past and future,” the Alexander lawsuit said.

Has much changed since?

As of May 20 of this year, the US version of the official Pfizer website references the potential severity of Zithromax Stevens Johnson Syndrome on the Zithromax product page - but only through a section under the header “for Health Care Professionals: Zithromax US Physician Prescribing Information.” Opening the HTML file reveals detailed information useful to doctors and health care professionals, including this…

“Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported rarely in patients on azithromycin therapy. Although rare, fatalities have been reported.”

However, a consumer concerned about potential Zithromax side effects are directed to a PDF file titled “ZITHROMAX US Patient Product Information.” Opening the document references only information for Zithromax for children.

And here’s the section on reactions:

“Allergic reactions to ZITHROMAX are rare, but these can be very serious if not treated right away by a doctor. If you think your child might be having an allergic reaction to ZITHROMAX, stop the medicine and call the doctor right away. If you cannot reach the doctor, go to the nearest hospital emergency room. Symptoms of a severe allergic reaction may include trouble breathing; swelling of the face, mouth and neck; or severe skin rash or blisters. ZITHROMAX may cause other less common side effects besides those listed here.”

There is no reference to Stevens Johnson Syndrome, or the fact that a severe case of SJS can prove fatal. There is only reference to an allergic reaction that can prove serious. Critics complain - as have plaintiffs in many a Zithromax lawsuit - that “serious” is a word that means different things to different people. How do you interpret serious? What does “serious” mean?

Not much has changed

There is no reference to the horrors of Stevens Johnson Syndrome. Would a parent carry a different view of Zithromax if it was spelled out that in rare cases a child could wind up in the hospital with full-body blistering, including blisters inside the mouth and throat? Would a parent consider giving their child the cherry suspension Zithromax if they could envision their child in the burn unit of a hospital, with entire sheets of skin blistering and sloughing away? Would they give the medication if their child could wind up with permanent scarring or chronic light sensitivity?

Would the parent put that spoon of cherry suspension Zithromax in their child’s mouth, if there was a possibility their child could die a horrible death via an allergic reaction from the product?

To be fair, Zithromax is not the only medication against which a patient can have an allergic reaction. No one knows what causes it. Neither does anyone know why a medication that has been used successfully in the past could suddenly turn on you the next time it is used.

However, health care advocates and plaintiffs embroiled in Zithromax skin lawsuits make the point that they had the right to know just what the potentially rare skin reaction is, and how serious it could be. But the patient information available on the Zithromax page at Pfizer.com doesn’t tell you. Information intended for health care professionals is a little more specific. However, would a patient or a parent go to the trouble of looking at information intended for doctors? Would they even feel they had the right to look?

“[Zithromax] lacked sufficient warnings of the hazards and dangers to users of said product and failed to provide safeguards to prevent the injuries sustained by the plaintiff,” the Alexander Zithromax lawsuit said (Aleigh Alexander et al. v. Pfizer Inc. et al., Case No. 155812/2012, in the Supreme Court of the State of New York, County of New York).

That Zithromax skin rash lawsuit was filed in August 2012 - two months after the FDA sent its letter to Pfizer over Zmax marketing. Two years later, it appears, not much has changed…