FDA: Pfizer Downplayed the Side Effects of Zithromax, Azithromycin
By Christina Drury
Drug manufacturers often encounter criticism about downplaying the risks and side effects associated with their drugs. One such side effect that has been significantly downplayed is Stevens Johnson Syndrome. Occasionally, if the drug seems to be causing multiple complaints, the FDA will get involved and send a warning letter to the drug company.
The FDA has sent a warning to the makers of drugs containing azithromycin addressing the risk of serious side effects. These drugs include Zithromax, Z-Pak and Zmax. There are several different drugs that have been linked to SJS and those companies included a warning on their labels about a potential allergic reaction, but patients who have developed SJS state that the warning is not sufficient enough to address the severity of the condition.
Medications Do Not Include Pertinent Information
Numerous medications that have been associated with the development of Stevens Johnson Syndrome do not include specific warnings about the seriousness of the condition and what signs and symptoms to look for. The only information that is often provided is a small warning that an allergic reaction is possible and if a patient develops a rash, they should seek medical attention.
However, some of the conditions that are being treated can cause rashes themselves, leading some patients to believe that the rash is a result of their illness and not the medication. Despite the fact that SJS is indeed an allergic reaction caused by medications, even drugs that have been previously taken and tolerated by the patient, indicating that SJS is a simple allergic reaction, instead of a life-threatening one, does not express the severity of the condition.
FDA Warns Pfizer about Zithromax
Multiple drug companies, including Zithromax manufacturer Pfizer, have been cautioned by the FDA not to minimize the severity of Stevens Johnson Syndrome. The FDA issued a warning letter to Pfizer concerning a brochure the company distributed about a “one day, one dose” drug called Zmax. The letter stated that the brochure did not properly outline the severity of SJS or the fact that some patients have continued to experience serious allergic reactions even after discontinuing the medication. The current label at the time only mentioned that some symptoms may reoccur after the drug is stopped, but again did not mention the severe and possibly fatal symptoms.
Have You Developed SJS?
Zithromax is an antibiotic that is prescribed to treat mild to moderate infections, such as pneumonia and bacterial sinusitis. Stevens Johnson Syndrome is a serious and potentially fatal allergic reaction that is caused by drugs such as azithromycin. SJS often first appears as a rash with some swelling and continues to worsen to the point where skin sloughs off. Individuals who have suffered and survived SJS are often left with permanent damage, including vision problems, scarring and organ damage.
If you or a loved one has developed Stevens Johnson Syndrome as a result of taking a medication, you may be entitled to receive compensation. Please visit our Stevens Johnson Syndrome Class Action Lawsuit Settlement Investigation page to learn more about the current lawsuit and how you can get involved.
Updated March 15th, 2013
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