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Federal regulators warn that the side effects of Biaxin, a widely used antibiotic, could increase the risk of serious heart problems or death for patients with heart disease.
The FDA issued a drug safety communication on Thursday, indicating that doctors should prescribe Biaxin (clarithromycin) with caution among individuals with heart disease.
The warning comes following a review of data from a large clinical trial, which found that the risk of death among Biaxin patients with heart disease was significantly higher compared with patients given a placebo.
The FDA announced that it is adding a new warning about the increased risk of death in patients with heart disease, and recommends doctors use another antibiotic when treating such patients. The agency is also adding the study’s results to Biaxin warning labels.
“There is no clear explanation for how clarithromycin would lead to more deaths than placebo,” the FDA warning notes. “Some observational studies also found an increase in deaths or other serious heart-related problems, while others did not.”
In January 2016, study published by researchers from Hong Kong also found that the risk of heart attacks was more than double among Biaxan users, compared to those given amoxicillin. A similar study published in 2013 also found an increased risk of Biaxin heart problems among patients with chronic obstructive pulmonary disease (COPD).
Biaxin and other clarithromycin antibiotics are used to treat a wide range of infections, including those affecting the lungs, skin, ears and sinuses.The drug belongs to a class of antibiotics known as macrolides. Zithromax (azithromycin) is another antibiotic in the same class, which has also recently been linked to a risk of heart problems.
In March 2013, the FDA issued a warning about the potential side effects of Zithromax, indicating that the antibiotic may disrupt the electrical activity of the heart. Zithromax is also known as the Z-Pak or Zmax.
A May 2012 study published in the New England Journal of Medicine first warned about the potential heart risks with Zithromax. Researchers found patients were 2.5 times more likely to die due to heart related problems on a five day Zithromax treatment when they compared it to treatment with other antibiotics or no antibiotic therapy.
For Biaxin, the FDA recommends that healthcare professionals be aware of the significant risks to patients with heart disease and weigh the risks and benefits before prescribing Biaxin to any patient. The agency also advises medical professionals with heart disease of the signs and symptoms of heart problems when prescribing Biaxin.
Patients are advised to tell their doctors if they have heart disease, especially when being prescribed an antibiotic. They are also advised not to stop taking heart disease medication or an antibiotic before first talking to their healthcare professional.
The FDA also requests that healthcare professionals and patients report any adverse events or side effects related to the use of Biaxin to the FDA’s MedWatch adverse event reporting program.