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Common HIV Antibiotic Flagged for Serious Heart Risk by FDA

Common HIV Antibiotic Flagged for Serious Heart Risk by FDA

The Food and Drug Administration (FDA) issued a new warning about the risk of heart disease for people who take clarithromycin.

Biaxin an antibiotic commonly prescribed to people living with HIV. The warning cites evidence from a 10-year follow-up study of patients with coronary heart disease as part of a larger clinical trial that found serious dangerous effects from short and long-term use of the drug.

Since HIV itself has been causally linked to increased heart disease risk, cardiovascular health should be at the top of the list of priorities for people living with HIV and compounding that risk should be avoided at all costs.

Biaxin is prescribed by doctors, most frequently, to treat Mycobacterium avium complex (MAC) infection, a lung infection that commonly affects people living with HIV. But its risk may outweigh its benefits, even when taken for a short period. Any drug that can damage the heart should set off red alarms in your head. Clarithromycin can kill even years later, according to NBC News.

In what is now being called the CLARICOR trial, researchers observed an “unexpected increase” in deaths among patients with heart disease who received a two-week course of clarithromycin after patients had been observed for one year or longer.

Researchers noted that six observational studies have observed patients with or without coronary artery disease, and two found evidence of long-term risks from clarithromycin, while four did not.

Results from the placebo-controlled CLARICOR trial, researchers claim, provide the strongest evidence to date of the increase in cardiovascular risk compared to past observational study results. Despite these repeated studies, the FDA is unable to determine why the risk of death is greater for patients with heart disease.

The FDA, however, didn’t provide any specific numbers. “Healthcare professionals should be aware of these significant risks and weigh the benefits and risks of clarithromycin before prescribing it to any patient,” the FDA wrote, “particularly in patients with heart disease and even for short periods, and consider using other available antibiotics. Advise patients with heart disease of the signs and symptoms of cardiovascular problems, regardless of the medical condition for which you are treating them with clarithromycin.” The FDA also mentions that clarithromycin is common in people living with HIV.

Clarithromycin has been approved for certain infections for more over 25 years and is sold under the brand name Biaxin. Clarithromycin is used to treat an array of infections including those that infect the skin, ears, sinuses, lungs and other areas. The FDA and the medical community have known about the coronary risks associated with clarithromycin since 2005 but its risks weren’t well understood until now.

Researchers observed the effects of antibiotics including azithromycin, erythromycin and clarithromycin and found that these all antibiotics can negatively impact people who suffer with heart disease. Abnormal heart issues, like infrequent cases of arrhythmia have been reported.

“FDA officials urge patients to inform health care professionals if they have heart disease, especially when being treated for an infection. Patients should also not discontinue clarithromycin treatment without consulting their health care provider,” a press release reads.

Approximately 20 percent of people living with HIV will die of heart disease. Part of this can be explained by the fact that heart disease can be a major risk to all people in general. Both healthcare providers and people living with HIV need to know of the risks that are compounded by combining drugs with HIV.

People living with HIV should consider other antibiotics with lesser known negative side effects before taking clarithromycin.



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Benjamin M. Adams