FDA warns some antibiotics can cause fatal heart damage

Certain antibiotics can cause painful and sometimes fatal damage to the body's main artery, the Food and Drug Administration said Thursday.

Fluoroquinolone antibiotics might raise the risk of an aortic dissection, and people who are already at risk should be cautious about taking those antibiotics, the FDA said.

"A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death," the FDA said in a statement.

"Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available. People at increased risk include those with a history of blockages or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain genetic disorders that involve blood vessel changes, and the elderly."

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The FDA said the new risk guidance will be added to the labels and prescribing information of fluoroquinolone drugs. The agency has already warned that the powerful drugs should only be used when absolutely necessary because they can cause other side effects involving tendons, muscles, joints, nerves and the central nervous system.

"Health care professionals should avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients. Prescribe fluoroquinolones to these patients only when no other treatment options are available," the FDA said.

Patients should call 911 or get to an emergency room if they feel symptoms of an aortic dissection, which include sudden, severe, and constant pain in the stomach, chest or back, the FDA said.

People who have high blood pressure, who know they have an aneurysm — a thinning of the artery walls — or heart disease should tell their doctors before taking antibiotics.

High blood pressure is the main cause of aortic dissections, which involves the inner layer of the wall or the aorta tearing away from the middle wall.

Fluoroquinolones are very commonly used antibiotics. They include: ciprofloxacin, also known as Cipro; levofloxacin, or Levaquin; gemifloxacin, or Factive; and moxifloxacin, or Avelox.

They are widely prescribed to treat upper respiratory infections and urinary tract infections.

"Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately," the FDA said.

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