Harsher FDA Warning on Pfizer Antibiotic

Harsher FDA Warning on Pfizer Antibiotic

March 13th, 2013 // 2:51 pm @

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FDA increased the strength of the warning for the antibiotic Zithromax, saying there is a small chance the product may trigger a potentially fatal, irregular heart rhythm.

Zithromax is a commonly used antibiotic that is also available as a generic drug, azithromycin.

The FDA posted a notice on its website Tuesday, stating that the drug label for azithromycin has been updated to warn that the product cause changes in the heart’s electrical activity, which in turn can cause abnormal heart rhythms.

The agency said patients who are at higher risk of developing heart-related electrical problems include those with existing heart trouble, those with low blood levels of potassium or magnesium and people with a slower-than-normal heart rate.

In a statement, Pfizer said it has updated the drug label in collaboration with the FDA to warn of the “specific, rare heart rhythm abnormality.” The company said Zithromax, which comes in a version administered for five days, has been safely used for more than 20 years to treat many types of bacterial infections.

Other drugs that fall into the same class of azithromycin carry a similar heart-related risk, the FDA said, in addition to another category of antibiotics called fluoroquinolones.

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More than 40 million people received a prescription for azithromycin in 2011, according to the FDA. The antibiotic is approved to treat a variety of infections including sinusitis and pneumonia.


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