Zithromax Side effects
Adverse effects of Zithromax reported to FDA
Potential Signals of Serious Risks/New Safety Information
Identified by the Adverse Event Reporting System (AERS) between
January – March 2010
The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period January - March 2010 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk.
It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.
FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.
FDA Safety Labeling Changes FDA Safety Changes: Zithromax,
Frova, Lexiscan News
Author: Yael Waknine CME Author: Yael Waknine Authors and Disclosures CME/CE Released: 05/13/2009;
May 13, 2009 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise that concomitant use of azithromycin may potentiate the effects of oral anticoagulants, frovatriptan succinate is linked to a risk for serotonin syndrome that is increased by coadministration of antidepressants, and regadenoson injection may cause heart block and hypotension in some patients.
The Warnings and Precautions, Contraindications, and Adverse Reactions sections of the labeling for Zithromax were updated January 2011, to include liver failure. Azithromycin (Zithromax) Labeling approved January 28, 2011 (PDF - 459KB)
Zithromax Side Effects Report #5564775-0
Zithromax side effect was reported by a Consumer or non-health professional from UNITED STATES on Dec 13, 2007.
Male patient, child 12 years of age, weighting 115.0 lb, was diagnosed with bronchitis What is bronchitis and was treated with Zithromax. After drug was administered, patient experienced the following side effects: asthenia, eye disorder, liver disorder, photophobia, renal disorder, stevens-johnson syndrome. Zithromax dosage: unknown. Patient was hospitalized. Patient recovered.
Zithromax Side Effects Report #5025874-5
Zithromax side effect was reported by a Consumer or non-health professional from UNITED STATES on Apr 22, 2005.
Male patient, child 12 years of age, was diagnosed with bronchitis What is bronchitis, pyrexia and was treated with Zithromax. After drug was administered, patient experienced the following side effects: stevens-johnson syndrome. Zithromax dosage: unknown. During the same period patient was treated with MOTRIN. Patient recovered.
Zithromax Side Effects Report #5024731-8 Zithromax side effect was reported by a Physician from UNITED STATES on Feb 23, 2006.
Female patient, 38 years of age, was diagnosed with ill-defined disorder and was treated with Zithromax. After drug was administered, patient experienced the following side effects: stevens-johnson syndrome. Zithromax dosage: unknown. Patient recovered.
Zithromax Side Effects Report #5025737-5
Zithromax side effect was reported by a Consumer or non-health professional from UNITED STATES on Dec 02, 2005. Female patient, 16 years of age, was diagnosed with upper respiratory tract infection and was treated with Zithromax.
After drug was administered, patient experienced the following side effects: stevens-johnson syndrome, toxic epidermal necrolysis. Zithromax dosage: unknown. During the same period patient was treated with ACETAMINOPHEN, IBUPROFEN, ROBITUSSIN, CEFTRIAXONE, LIDOCAINE, DOPAMINE. Patient was hospitalized. Patient recovered.
Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported as a Zithromax Side Effect.
NEJM: Common antibiotic linked to a few CV deaths, prompting FDA review
There was a small absolute increase in cardiovascular deaths, which was most pronounced among patients with a high baseline risk of cardiovascular disease during the five-day administration of the antibiotic
azithromycin (
Zithromax, Pfizer) therapy. This study, which evaluated nearly 350,000 prescriptions of azithromycin and was published May 17 in the
New England Journal of Medicine, has prompted an FDA review of its results.
Although several macrolide antibiotics are proarrhythmic and associated with an increased risk of sudden cardiac death,
azithromycin is thought to have minimal cardiotoxicity, according to the study authors. However, they added published reports of arrhythmias suggest that
azithromycin may increase the risk of cardiovascular death.
Specifically,
azithromycin, a broad-spectrum macrolide
antibiotic that is used to treat infections caused by bacteria, has been reported to be relatively free of cardiotoxic effects. However, there are at least seven published reports of patients with normal baseline QT intervals in whom
azithromycin had arrhythmia-related adverse cardiac effects, including pronounced QT-interval prolongation,
Torsades de pointes and polymorphic ventricular tachycardia in the absence of QT-interval prolongation. The FDA's Adverse Event Reporting System includes at least 20 reports of Torsades de pointes associated with azithromycin.
In the study, Wayne A. Ray, PhD, a professor of preventive medicine at Vanderbilt University Medical Center in Nashville, Tenn., and colleagues studied a Tennessee Medicaid cohort designed to detect an increased risk of death related to short-term cardiac effects of medications, and excluded patients with serious non-cardiovascular illness and person-time during and shortly after hospitalization.
“An important concern in this observational study was confounding by factors associated with both
azithromycin use and an increased risk of cardiovascular death,” wrote the study authors. “These factors include cardiovascular disease and other coexisting conditions, behavioral risk factors associated with cardiovascular disease (e.g., smoking, high body mass index, poor diet and low physical activity) and indication for
antibiotic therapy.....”
http://www.cardiovascularbusiness.com/index.php?option=com_articles&view=article&id=34047:nejm-common-antibiotic-linked-to-a-few-cv-deaths-prompting-fda-review
