FDA Looks Into Zithromax Side Effects
By Christina Drury
Zithromax is one of the most widely prescribed antibiotics in America. This is partly due to its effectiveness, and also due to the fact that it comes in a shorter dosage – 5 days instead of 10. However, Zithromax has been linked recently to the development of the rare yet sometimes fatal disease Stevens Johnson Syndrome, and even more recently to cardiac problems.
In 2012, the U.S. Food and Drug Administration became aware of a study that was published in a medical journal that warns about the possibility of Zithromax-induced heart problems, some that can prove to be fatal and occur suddenly without warning.
FDA Requires Zithromax Labeling Update
The FDA has stated that it will review a study published in the New England Journal of Medicine that identified a link between the use of Zithromax and an increased risk of cardiovascular deaths. Once the review of the study has been completed, the FDA will notify physicians and consumers about the overall review and the actions that will be necessary, if any. The study consists of about 350,000 patients with the conclusion that those who took Zithromax were more likely to suffer from sudden cardiovascular death.
The FDA conducted a similar review in 2011 with macrolides – a class of antibacterial drugs – and this resulted in an update to Zithromax side effect labeling practices. Specifically, the Zithromax label was updated in March of 2012 to include the possibility of QT interval prolongation as well as TdP. Despite the fact that the risk is assumed to be low, it is important information for consumers and physicians to be aware of.
FDA Warns Both Consumers and Physicians
During the course of the review of the medical study, the FDA cautions consumers against discontinuing the drug without the knowledge of their physician. Antibacterial drugs must be taken in their full dose to be effective and to prevent the body from developing immunity to the drug.
Additionally, the FDA cautioned physicians to be diligent in the research of the potential side effects of Zithromax and to prescribe the antibiotic only to patients with low-risk factors. This means avoiding prescribing Zithromax to any patient with a history of heart problems or hypersensitivity to medications.
Patients should also be diligent and pay attention to the medications that they are taking so they can be aware of any strange or unusual symptoms that occur and immediately notify their caretaker.
Zithromax Legal Help Available
Patients who have been injured by Zithromax or Z-Pak side effect have legal options. Visit the Zithromax, Z-Pak, Azithromycin Heart Attack, Stevens Johnson Syndrome & Toxic Epidermal Necrolysis Class Action Lawsuit Settlement & Investigation page for more information. Here you can also submit your personal information to get in touch with drug injury lawyers who can guide you – free of charge – through the litigation process.
Updated April 26th, 2013
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