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ZITHROMAX SIDE EFFECTS Stevens Johnson Syndrome

Zithromax antibiotics tied to rare heart risks

(AP) CHICAGO -- An antibiotic widely used for bronchitis and other common infections seems to increase chances for sudden deadly heart problems, a rare but surprising risk found in a 14-year study.

Zithromax, or azithromycin, is more expensive than other antibiotics, but it's popular because it often can be taken for fewer days. But the results suggest doctors should prescribe other options for people already prone to heart problems, the researchers and other experts said.

Vanderbilt University researchers analyzed health records and data on millions of prescriptions for several antibiotics given to about 540,000 Tennessee Medicaid patients from 1992 to 2006.

There were 29 heart-related deaths among those who took Zithromax during five days of treatment. Their risk of death while taking the drug was more than double that of patients on another antibiotic, amoxicillin, or those who took none.

To compare risks, the researchers calculated that the number of deaths per 1 million courses of antibiotics would be about 85 among Zithromax patients versus 32 among amoxicillin patients and 30 among those on no antibiotics. The highest risks were in Zithromax patients with existing heart problems.

 

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Office of Surveillance and Epidemiology (OSE) Dashboard

OSE continues to see an increase in the number of manufacturer adverse events received in the month.

In FY 11 OSE received 841,513 reports versus 658,604 in FY 10 resulting in a 28% increase.

OSE continues to make progress on their Safety First project.

The Safety First Initiative ensures drug safety throughout the drug lifecycle by giving pre-marketing drug review and post-marketing safety equal focus.

This calls for inter-office, multidisciplinary safety-issue teams to assess significant safety issues, recommend actions, and monitor sponsors’ activities.

They will be working through December 2012 on implementing their strategic plan.



ZITHROMAX Medical Research

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.

Azithromycin May Potentiate the Effects of Oral Anticoagulants

The FDA approved class labeling changes for azithromycin tablets and oral suspension to advise of a potential drug interaction with warfarin. On February 27, the label for Zithromax (Pfizer, Inc) was updated.

Although data from a pharmacokinetic study of 22 healthy men taking a 5-day course of azithromycin did not support an interaction with subsequently administered warfarin, postmarketing reports suggest that azithromycin may potentiate the effects of oral anticoagulants.

The FDA advises careful monitoring of prothrombin time in warfarin-treated patients receiving a course of azithromycin.

Azithromycin is a macrolide antibiotic indicated for the treatment of nongonococcal urethritis and cervicitis as a result of Chlamydia trachomatis and for the prophylaxis and treatment of disseminated Mycobacterium avium complex disease.

Warfarin is an oral anticoagulant indicated for the prophylaxis and/or treatment of venous thromboembolism and pulmonary embolism; thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement; and to reduce the risk for death, recurrent myocardial infarction, and thromboembolic events after myocardial infarction.

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.

Azithromycin May Potentiate the Effects of Oral Anticoagulants

The FDA approved class labeling changes for azithromycin tablets and oral suspension to advise of a potential drug interaction with warfarin. On February 27, the label for Zithromax (Pfizer, Inc) was updated.

Although data from a pharmacokinetic study of 22 healthy men taking a 5-day course of azithromycin did not support an interaction with subsequently administered warfarin, postmarketing reports suggest that azithromycin may potentiate the effects of oral anticoagulants.

The FDA advises careful monitoring of prothrombin time in warfarin-treated patients receiving a course of azithromycin.

Azithromycin is a macrolide antibiotic indicated for the treatment of nongonococcal urethritis and cervicitis as a result of Chlamydia trachomatis and for the prophylaxis and treatment of disseminated Mycobacterium avium complex disease.

Warfarin is an oral anticoagulant indicated for the prophylaxis and/or treatment of venous thromboembolism and pulmonary embolism; thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement; and to reduce the risk for death, recurrent myocardial infarction, and thromboembolic events after myocardial infarction.

ZITHROMAX

SIDE EFFECT

News

WHAT ARE THE SIDE EFFECTS?

The side effects of zithromax (azithromycin) mostly affect the digestive system. They include diarrhea, nausea, and pain in the abdomen. Some people get very sensitive to sunlight. Others may get headaches, be dizzy or sleepy, or have some problems hearing. Very few people who take azithromycin get these side effects.

Some people get a severe allergic reaction to azithromycin. Let your health care provider know immediately if you get severe diarrhea, fever, joint pain, serious stomach cramps or pain, swelling in your neck, mouth, hands and feet, or trouble breathing.

Antibiotics kill some helpful bacteria that normally live in the digestive system. You can eat yogurt or take supplements of acidophilus to replace them.

(azithromycin) IV February 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2009
The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.