What is Levaquin?
Levaquin (generic: levofloxacin) belongs to a group of antibiotics called fluoroquinolones that fight bacteria in the body. The drug is prescribed to treat a variety of bacterial infections, as well as to treat patients who have been exposed to anthrax or plague. Levaquin is made by Janssen Pharmaceuticals (a Johnson & Johnson company), and was approved by the U.S. Food & Drug Administration (FDA) in July 1999.
What’s the Problem?
Unfortunately, fluoroquinolone antibiotics like Levaquin have been linked to serious side effects including nerve damage, aortic aneurysms (bulges) and dissections (tears). Damage to the aorta, the largest artery in the human body, can lead to heart attack, stroke and even death.
Levaquin Side Effects
Serious side effects of Levaquin may include:
- Peripheral neuropathy
- Aortic aneurism
- Aortic dissection
- Collagen disorders
- Muscle weakness
- Tendon ruptures
- Central nervous system disorders
- Cardiovascular collapse
- Life-threatening skin reactions
- Toxic epidermal necrolysis (TEN)
- Stevens-Johnson syndrome (SJS)
- Clostridium difficile associated diarrhea
- And more
On August 15, 2013, FDA issued a Drug Safety Communication stating that fluoroquinolone antibiotics had been associated with an increased risk for peripheral neuropathy, a condition that develops as a result of damage to the peripheral nervous system. The agency issued the communication because prior warnings did not adequately describe the potential rapid onset of the condition.
“In some patients the symptoms had been ongoing for more than a year despite discontinuation of the fluoroquinolone,” FDA said. “Several patients were continued on the fluoroquinolone drug despite the occurrence of neuropathic symptoms.”
Symptoms of Neuropathy
Each nerve in the peripheral system has a specific function, so symptoms depend on the type of nerves affected. Nerves are classified into:
- Sensory nerves that receive sensation (temperature, pain, vibration or touch) from the skin;
- Motor nerves that control muscle movement, and
- Autonomic nerves that control functions such as blood pressure, heart rate, digestion and bladder.
Signs and symptoms of peripheral neuropathy may include:
- Gradual onset of numbness, prickling or tingling in your feet or hands, which may spread into the arms and legs
- Sharp, jabbing, throbbing, freezing or burning sensation
- Extreme sensitivity to touch
- Lack of coordination / falling
- Muscle weakness / paralysis (if motor nerves are affected)
If autonomic nerves are affected, symptoms of neuropathy may include:
- Heat intolerance / excessive sweating
- Bowel, bladder or digestive problems
- Changes in blood pressure
- Dizziness / lightheadedness
Aortic Aneurysm / Aortic Dissection
A November 2015 study published in JAMA Internal Medicine found that fluoroquinolone antibiotics could increase the risk of aortic aneurysm or aortic dissection by degrading collagen in patients’ bodies. Aortic aneurysm occurs when an abnormal bulge develops in the aorta, the largest artery in the human body. Dissection is characterized by a tear in the wall of the aorta.
For the study, researchers compared 1,477 patients who were hospitalized with aortic aneurysm or dissection to 147,700 controls.
“After propensity score adjustment, current use of fluoroquinolones was found to be associated with increased risk for aortic aneurysm or dissection (rate ratio [RR], 2.43; 95% CI, 1.83-3.22), as was past use, although this risk was attenuated (RR, 1.48; 95% CI, 1.18-1.86),” the researchers said. “While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy.”
FDA Black Box Warning
On May 12, 2016, the FDA issued a Drug Safety Communication stating that new warnings would be added to the labeling of fluoroquinolone antibiotics regarding an increased risk of nerve and muscle damage. The agency is calling for an updated boxed warning to inform patients that risks of the drugs may outweigh benefits in patients with sinusitis, bronchitis and uncomplicated UTIs. Fluoroquinolone side effects may include damage to tendons, muscles, joints, nerves and central nervous system, according to the FDA.
Quinolone Vigilance Foundation
The Quinolone Vigilance Foundation (QVF) was formed to spread awareness of the dangers of fluoroquinolone antibiotics, and to fund research on potential health risks of the medications. QVF supports increased warnings, and seeks to have fluoroquinolone prescriptions limited to patients with life-threatening infections.
Lawsuits alleging nerve damage from fluoroquinolone antibiotics are pending in state and federal courthouses across the country. At one time, over 2,000 Levaquin lawsuits were consolidated into a multidistrict litigation (MDL No. 08-1943) before U.S. District Judge John R. Tunheim in Minnesota. Several were settled out of court for confidential amounts. As of December 2015, less than 20 complaints were pending in the MDL.
1999 – Approved by the FDA
July 1999 – Levaquin approved by the U.S. Food & Drug Administration (FDA).
2008 – Multidistrict litigation formed
August 2008 – Levaquin multidistrict litigation (MDL No. 08-1943) formed in the U.S. District Court for the District of Minnesota.
2011 – Generic versions approved
June 20, 2011 – First generic versions of levofloxacin approved by the FDA.
2013 – FDA Drug Safety Communication issued
August 15, 2013 – FDA Drug Safety Communication issued regarding a potential increased risk of peripheral neuropathy with fluoroquinolone antibiotics.
2015 – JAMA Internal Medicine study findings
November 2015 – JAMA Internal Medicine study finds an increased risk of aortic aneurysm and aortic dissection with fluoroquinolones.
2016 – FDA requires new warnings
May 12, 2016 – FDA requires new warnings to be added to fluoroquinolone labels regarding an increased risk for damage to tendons, muscles, joints, nerves and central nervous system (CNS).
- “Levaquin MDL | 08-MD-1943”. U.S. District Court for the District of Minnesota”. August 2008.
- “FDA approves first generic versions of the antibiotic levofloxacin to treat certain infections”. U.S. Food & Drug Administration (FDA). June 20, 2011.
- “FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection”. U.S. Food & Drug Administration (FDA). August 15, 2013.
- “Aortic Dissection”. MedlinePlus, U.S. National Library of Medicine. May 27, 2014.
- “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone”. JAMA Internal Medicine. November 2015.
- “FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together”. U.S. Food & Drug Administration (FDA). May 12, 2016.
- “Peripheral Neuropathy: Symptoms and Causes”. Mayo Clinic.
- “Heart Disease and Aortic Aneurysm”. WebMD.
- “Welcome to the home of the Quinolone Vigilance Foundation (QVF)”. Quinolone Vigilance Foundation.