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Is Pfizer Forthcoming to Consumers About Zithromax Stevens Johnson Syndrome?

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Washington, DCStevens Johnson Syndrome (SJS) is one of those rare reactions to medication that few understand. Why does skin erupt into a rash, then into blisters, then a progression toward the loss of massive amounts of skin that equates to a serious burn? And this, all happening practically overnight. Many questions, and even less understanding. But one thing is clear: Stevens Johnson Syndrome is usually triggered through a rare allergic reaction to medication. What is less clear is why some manufacturers are less forthcoming in telling the public that Zithromax SJS is a possibility.

To be fair, Zithromax, manufactured and marketed by Pfizer, is not the only medication that has been identified as having triggered Stevens Johnson Syndrome in some patients. Even medication as common as children’s Motrin has been known to trigger the syndrome. Thus, the issue is not necessarily what is in the medication that could trigger Zithromax reactions such as Stevens Johnson Syndrome, but why it affects some people and not others. The variable, therefore, appears to lay with the individual patient.

It is also important to point out that Stevens Johnson Syndrome remains a rare event, and is not part of a basket of more common Zithromax side effects the majority of the population might expect to encounter.

The fact remains, however, that most SJS lawsuits brought by plaintiffs allege that manufacturers have not been completely forthcoming in warning consumers about this possibility, rare as it is.

Zithromax is a robust and effective antibiotic prescribed to treat serious infections. And mirroring the mantra of the US Food and Drug Administration (FDA), a medication is appropriate for the market if the benefits outweigh the risks for the intended population and indications. Fighting a serious infection, as opposed to the risks of leaving an infection untreated, suggests a better risk profile than the minute possibility of experiencing a Zithromax rash that could mushroom, in a matter of hours or days, into full-blown Stevens Johnson Syndrome.

Zithromax Stevens Johnson Syndrome can be fatal

But tell that to the small percentage of patients who experience the horror of SJS. They may rather have taken their chances with the infection than go through Stevens Johnson Syndrome. Especially since SJS has been fatal.

Plaintiffs have faulted manufacturers for not being forthcoming in listing Stevens Johnson Syndrome, in an obvious way, as a rare but in the same breath a very real possibility.

Any plaintiff bringing a Zithromax lawsuit against Pfizer might well make the point that on the official Pfizer Zithromax (azithromycin) web page, the prescribing information for US physicians notes that Zithromax Stevens Johnson Syndrome can be fatal, and that there have been fatalities.

The HTML document is listed under the heading: “for Health Care Professionals.” Under subsection 5.1 “Hypersensitivity,” doctors are told that Zithromax SJS has been reported, as well as the more serious toxic epidermal necrolysis.

“Fatalities have been reported.”

This document is for doctors and health care professionals. Pfizer, it is assumed, is relying on the doctor to inform his or her patient that Zithromax Stevens Johnson Syndrome is a possibility, as there is no such dire warning carried by documentation meant for patients and consumers.

Indeed, in the patient summary on the same web page - and we’ve made this point before - the reference is for cherry-flavored suspension for children. The consumer is urged to read the information carefully and discuss any concerns with their doctor. However, the most serious suggestion of a bad outcome in the patient information is the possibility of an allergic reaction.

“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.”

There is no mention of Zithromax side effects that could prove fatal. There is no reference to Stevens Johnson Syndrome or Zithromax SJS at all. Any consumer visiting the Pfizer Zithromax page can, at his or her option, open up the document meant for health care professionals and read it. To that end, the document is accessible. However, it is also written for doctors and health care professionals and is much more involved than the patient information document, which is presumably penned to appeal to the general population.

Is Pfizer fulfilling an FDA mandate to note the potential for Zithromax Stevens Johnson Syndrome - a rare reaction that could prove fatal?

Probably.

But does it adequately inform the public that there are Zithromax reactions that could, in rare cases, actually prove fatal?

You be the judge.

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