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Stevens Johnson Syndrome: Zithromax Maker Warned About Zmax

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New York, NYDrug companies often face criticism that they downplay the risk of side effects, especially the risk of serious side effects such as Stevens Johnson Syndrome. In some cases, the US Food and Drug Administration (FDA) gets involved, as it did when it sent a warning letter about the risk of azithromycin side effects to the drug’s maker. Although many drugs linked to SJS include a warning about a possible allergic reaction, patients who developed SJS say the warning was not adequate, given the severity of the situation.

Many medications that have been linked to Stevens Johnson Syndrome do not give specific warnings about what the condition looks like or how serious it can be. They simply warn that an allergic reaction can occur and if a rash appears, the patient should seek medical attention. But in some cases the condition the medication is treating also causes a rash, causing patients to believe the rash is linked to their being ill, not to taking the medication.

Although technically Stevens Johnson Syndrome is indeed an allergic reaction to medication - even medication that has been previously tolerated by the patient - referring to Stevens Johnson Syndrome as an allergic reaction as opposed to a life-threatening reaction might not convey the severity of the situation.

Drug companies - including Pfizer, maker of Zithromax - have been warned by the FDA not to minimize the risks of Stevens Johnson Syndrome. On June 19, 2012, the FDA sent a warning letter to Pfizer (found online at www.fda.gov), regarding the company’s “1 Day. 1 Dose” brochure for a drug called Zmax (azithromycin extended-release medication). The agency warned Pfizer that its brochure did not explain the severity of Stevens Johnson Syndrome - which can be fatal - and further did not note that some patients experienced continued severe allergic symptoms even after they stopped taking Zmax (the warning label did note that some symptoms recurred without further exposure to the drug but did not note how severe those symptoms were).

Zmax is used to treat mild to moderate infections including acute bacterial sinusitis and community-acquired pneumonia. Stevens Johnson Syndrome is a potentially fatal allergic reaction to medications including azithromycin. It often starts with a rash and swelling, and develops to the point where the patient’s skin sloughs off. Often the patient suffers permanent scarring, organ damage and vision problems.

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