Avelox Lawsuit

What is Avelox?

Avelox (generic: moxifloxacin) belongs to a group of antibiotic medications called fluoroquinolones that work by fighting bacteria in the body. The drug is used to treat a variety of bacterial infections, as well as for the treatment and prevention of plague. Avelox is made by Merck & Co., and was approved by the U.S. Food & Drug Administration (FDA) in December 1999.

Which Other Drugs are Fluoroquinolones?

In addition to Avelox, other antibiotic medications in the fluoroquinolone class include:

Levaquin (levofloxacin)
Cipro (ciprofloxacin)
Noroxin (norfloxacin)
Floxin (ofloxacin)
Factive (gemifloxacin)

What’s the Problem?

Fluoroquinolone antibiotics like Avelox have long been known to increase the risk of tendon ruptures and retinal detachment due to the drugs’ ability to degrade collagen and other connective tissue. It has also recently been found that these same side effects may also damage the aorta, the main artery in the human body.

Avelox Side Effects

Peripheral neuropathy
Aortic aneurism
Aortic dissection
Collagen disorders
Muscle weakness
Tendon ruptures
Retinal detachment
Central nervous system disorders
Cardiovascular collapse
Life-threatening skin reactions
Toxic epidermal necrolysis (TEN)
Stevens-Johnson syndrome (SJS)
Clostridium difficile associated diarrhea
And more

Nerve Damage / Peripheral Neuropathy

On August 15, 2013, FDA issued a Drug Safety Communication indicating that labels of fluoroquinolone antibiotics would be changed to include a warning about an increased risk of peripheral neuropathy, a potentially irreversible type of nerve damage that can appear rapidly after a patient begins treatment with the drug.

“The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection,” the agency said. “The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.”

Peripheral Neuropathy Symptoms

Pain / sensitivity to pain
“Pins-and-needles” sensation
Numbness
Weakness
Slow reflexes
Tingling feet / fingers
Poor balance
Cramping

Aortic Aneurysm / Aortic Dissection

A study published in JAMA Internal Medicine in November 2015 found that fluoroquinolone antibiotics may double the risk of the following potentially fatal injuries:

Aortic aneurysm – The aorta walls become weakened, resulting in an abnormal bulge as the pressure causes the weakened area to balloon outward.
Aortic dissection – A tear in the inner layer of the aorta.

“While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy,” the researchers concluded.

Aortic Aneurysm Symptoms

There are 2 common types of aortic aneurysm that produce different symptoms:

Thoracic aortic aneurysm (bulge in the upper part of the aorta) – Symptoms include chest pain, back pain, cough / shortness of breath, hoarseness and difficulty or pain when swallowing.
Abdominal aortic aneurysm (enlargement of the aorta around the abdomen) – Symptoms include abdominal pain or discomfort, pulsating sensation in the abdomen, “cold foot” or a black or blue painful toe, fever, weight loss and pain in the lower back, flanks, groin or legs.

Treatment / Repair

Aortic aneurysms may be treated with prescription drugs and/or surgery. Small aneurysms that are detected early and not causing symptoms may not require treatment. Other aneurysms may need to be treated.

In most cases, treatment is based on the size of the bulge. Routine testing may be ordered to ensure the aneurysm isn’t growing. This method is typically used for aneurysms that are less than 5 centimeters across.

FDA Issues New Warning on Fluoroquinolone Antibiotics

On May 12, 2016, the FDA issued a Drug Safety Communication stating that new warnings were being added to the labeling of fluoroquinolone antibiotics regarding an increased risk for damage to muscles, nerves and more. FDA said risks of the drugs may outweigh the benefits in patients with sinusitis, bronchitis and uncomplicated urinary tract infections.

Fluoroquinolone side effects may include damage to tendons, muscles, joints, nerves and the central nervous system. For patients with these conditions, fluoroquinolones should only be prescribed to those who have no other treatment options, according to the agency.

Avelox Timeline

December 10, 1999 – Approved by the FDA

December 10, 1999 – Avelox first approved by the U.S. Food & Drug Administration (FDA).

August 15, 2013 – Drug Safety Communication issued

August 15, 2013 – FDA Drug Safety Communication issued over increased risk of permanent nerve damage / peripheral neuropathy with fluoroquinolone antibiotics.

May 8, 2015 – Approved for plague patients

May 8, 2015 – Avelox approved to treat patients with plague.

November 2015 – JAMA Internal Medicine study findings

November 2015 – JAMA Internal Medicine study finds that users of fluoroquinolone antibiotics may face up to a 2-fold increased risk of developing aortic aneurysm and/or aortic dissection.

November 18, 2015 – BMJ Open study published

November 18, 2015 – Study published in BMJ Open links fluoroquinolones to a tripled risk of aortic aneurysm.

May 12, 2016 – Labels updated

May 12, 2016 – Fluoroquinolone labels updated to include a warning about an increased risk for damage to tendons, muscles, joints, nerves and the central nervous system (CNS).