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FDA Issues Warning About Acetaminophen for Side Effect Linked to Zithromax

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Washington, DCIt is one of the more rare of the Zithromax side effects, but Stevens Johnson syndrome has been linked to Zithromax and other antibiotics and pain relievers. Now, the US Food and Drug Administration (FDA) has issued a warning about the risk of Stevens Johnson syndrome (SJS) in certain pain relievers. The warning does not mention Zithromax reactions, but it does shed some light on the risk of SJS, and the harm that can be caused by the condition.

The FDA’s warning was issued August 1, 2013, and noted that acetaminophen can cause “rare but serious skin reactions.” The issue is that those rare but serious skin reactions are potentially fatal and are not always easily diagnosed, leading to further complications. “It is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious side effects, which are potentially fatal,” said Sharon Hertz, MD, deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction.

The FDA announced that all prescription medications that contain acetaminophen will now carry a warning about the skin conditions SJS and toxic epidermal necrolysis (TEN). Furthermore, the warnings will be added to labels of over-the-counter medications that contain acetaminophen.

According to the FDA, symptoms of SJS and TEN include flu-like symptoms, followed by a rash and blistering. Patients can suffer extensive damage to their skin and may face permanent scarring and damage to internal organs. Furthermore, they can develop SJS or TEN - an allergic reaction to medication - even if they have taken the medication with no adverse reactions.

The warning was issued after the FDA reviewed its database and found 107 cases of SJS and TEN linked to acetaminophen between 1969 and 2012. Of those, 12 people died and 67 were hospitalized.

Although the FDA’s warning does not include Zithromax (known generically as azithromycin), the medication has been linked to an increased risk of SJS. In 2012, the FDA warned Pfizer that its marketing material concerning Zmax (azythromycin extended release) downplayed the risk of Stevens Johnson syndrome. Patients who have developed SJS from taking other medications have filed lawsuits alleging they were not adequately warned about the risk. Many drugs contain only a warning about an allergic reaction, but do not mention how serious the allergic reaction can be.


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