Fluoroquinolone antibiotics such as Factive reportedly cause problems with the aorta including aortic aneurysm, according to the FDA.

Fluoroquinolones are a class of broad spectrum antibiotics commonly used to treat bacterial infections. Drugs in this class include Avelox (moxifloxacin), Cipro (ciprofloxacin), Levaquin (levofloxacin), Factive (gemifloxacin), Noroxin (Norfloxacin), and Floxin (ofloxacin). Over 20 million prescriptions are written for these drugs every year due to their effectiveness in killing infection-causing bacteria.

However, these medications may increase the risk for life threatening complications affecting the aorta. The aorta is one of the largest blood vessels in the body and carries blood out of the heart.

In December 2018, the U.S. Food and Drug Administration (FDA) released a safety announcement informing the public and healthcare professionals that fluoroquinolones such as Factive can increase the risk of aortic dissections and aneurysms.

“Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available,” the FDA warned in their announcement. “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.”

Other risk factors for aortic aneurysm may include lifestyle factors such as smoking and poor diet.

The aorta is composed of three layers which each play vital roles in the function of the blood vessel. When one of the walls is weakened, it can create a bulge in the blood vessel which is known as an aortic aneurysm.

Symptoms of an aortic aneurysm may include: a steady, deep, or throbbing pain in the stomach area; pain in the jaw, neck, back, or chest; coughing or hoarseness; shortness of breath; and trouble swallowing or breathing.

Aortic aneurysms usually do not pose any danger but require careful monitoring and can be life threatening if they progress to a full tear in the aorta, otherwise known as an aortic dissection.

When the inner wall of the aorta tears, it may result in a pooling of blood between two layers of the blood vessel. Over time, the force of blood flow can widen the tear in the aorta and weaken the outer later. Eventually, all of the layers of the aortic wall may tear – resulting in the pooling of blood in the body and other life threatening complications.

Due to the serious nature of these aortic events, the FDA announced that they were requiring additional warnings on fluoroquinolones to reflect the newly confirmed risks.

This is not the first time fluoroquinolones have been associated with adverse side effects. In 2008, the FDA warned that the antibiotics increased the risk of tendonitis and tendon rupture. Several years later in 2013, the agency warned the public again – this time about the increased risk of peripheral neuropathy (nerve damage).

In 2016, the FDA warned about significant blood sugar decreases and mental health side effects. The recent FDA announcement only adds to the laundry list of potential side effects associated with fluoroquinolone antibiotics.