Pharmaceutical Drug Litigation Updates

Antibiotic Zithromax label to warn of potential heart side-effect

Quoted from http://www.cbc.ca/news/health/story/2013/05/16/azithromycin-heart.html

Antibiotic Zithromax label to warn of potential heart side-effect

Health Canada says caution needed when treating patients with certain risk factors

The antibiotics Zithromax and Zmax SR (azithromycin) can cause potentially fatal irregular heart rhythms, Health Canada says.

Azithromycin is used for bronchitis, pneumonia, chest infections, urinary tract and other common infections.

Thursday's advisory from Health Canada says a "small absolute increase in the risk of cardiovascular deaths was observed in patients taking azithromycin as compared to those who took no antibiotics and those who took amoxicillin in a recent study."

In March, the U.S. Food and Drug Administration warned that the antibiotic, sold in Canada and the U.S. as Zithromax, can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm.

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Antibiotic Azithromycin Won't Harm Healthy Hearts: Study

Quoted from http://www.philly.com/philly/health/topics/HealthDay675895_20130501_Antibiotic_Azithromycin_Won_t_Harm_Healthy_Hearts__Study.html

Antibiotic Azithromycin Won't Harm Healthy Hearts: Study

Kathleen Doheny HealthDay Reporter

Posted: Wednesday, May 1, 2013, 5:00 PM

WEDNESDAY, May 1 (HealthDay News) -- The widely used antibiotic azithromycin (Zithromax or Zmax) -- under scrutiny recently because it may increase the risk of death for those with existing heart disease -- appears to be safe for young and middle-aged adults without heart problems, according to a large new study.

Danish researchers evaluated more than a million episodes of azithromycin use, comparing it to both the use of no antibiotics and to the use of penicillin V, from 1997 through 2010. Patients were aged 18 to 64.

"We believe that the results are reassuring," said Henrik Svanstrom, a researcher at Statens Serum Institute, in Copenhagen. His study is published in the May 2 issue of the New England Journal of Medicine.

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FDA warns about Zithromax and risk of fatal heart problems

Quoted from http://www.boston.com/dailydose/2013/03/12/fda-warns-about-zithromax-and-risk-fatal-heart-problems/gwH9zWy3ZBBmMfRPpgx1wI/story.html

FDA warns about Zithromax and risk of fatal heart problems

The US Food and Drug Administration issued a warning today about the popular and powerful antibiotic azithromycin (Zithromax or Zmax), saying that it could lead to a potentially fatal irregular heart rhythm in patients who are at higher risk for heart problems. These include people with low blood levels of potassium or magnesium or a slower than normal heart rate, or who use certain drugs to treat abnormal heart rhythms, or arrhythmias.

Patients who have existing QT interval prolongation -- a disorder of the heart’s electrical system -- or who have the rarer and more extreme form called torsades de pointes need to be especially cautious about using these antibiotics.

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Popular Antibiotic May Raise Risk of Sudden Death

Quoted from http://www.nytimes.com/2012/05/17/health/research/popular-antibiotic-may-raise-risk-of-sudden-death.html

Popular Antibiotic May Raise Risk of Sudden Death

By DENISE GRADY

Published: May 16, 2012

A new study finds that a widely used antibiotic, azithromycin, may increase the likelihood of sudden death in adults, especially those who have heart disease or are at high risk for it.

 

Photo Researchers, Inc.

A study links azithromycin to abnormal heart rhythms.

The increased odds of death are small, but significant enough that the authors of the study say doctors should consider prescribing a different drug, like amoxicillin, for high-risk patients who need antibiotics. People at high risk include those with heart failure, diabetes or a previous heart attack, and those who have undergone bypass surgery or have had stents implanted. In such patients, the drug may cause abnormal heart rhythms that can be fatal. Just how the drug might disrupt heart rhythm is not known, the researchers said.

The concerns do not apply to children, because most have very little risk of heart disease, according to the lead author of the study, Wayne A. Ray, a professor of preventive medicine at Vanderbilt University. The study is being published on Thursday in The New England Journal of Medicine.

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