What’s the Problem?
Recent studies have identified a link between Levaquin and other fluoroquinolone (FQ) antibiotic medications to an increased risk for severe, potentially fatal heart problems, including heart failure.
What is Levaquin?
Levaquin is a prescription antibiotic drug used to treat bacterial infections including pneumonia, acute bacterial sinusitis, and chronic bronchitis worsened by bacterial infections. Although the specific mechanism of action is not fully understood, Levaquin is believed to work primarily by killing bacteria. Levaquin was approved by the U.S. Food & Drug Administration (FDA) in 1996.
Study Links Fluoroquinolone Use to Adverse Cardiac Events
A recent study published in the Journal of the American College of Cardiology titled “Oral Fluoroquinolones and Risk of Mitral and Aortic Regurgitation” found a link between the use of fluoroquinolone antibiotics and severe cardiac events, specifically aortic dissection and aortic aneurysm.
For the study, a research team led by Mahyar Etminam took a disproportionality analysis from the FDA’s Adverse Events Reporting System (FAERS), using a random sample of 9,053,240 patients from the U.S. PharMetrics Plus database (IQVIA) as the matched nested case-control study. Current fluoroquinolone exposure was defined as an active prescription at the index date, or 30 days prior to the event date. Recent fluoroquinolone exposure was defined as FQ use within days 31 to 60, and past within days 61 to 365 prior to the event.
The researchers found that the risk of aortic and mitral regurgitation is greatest with current fluoroquinolone use followed by recent use. No risk was found with past use. Authors stressed that more studies are needed to better understand the risk of heart damage with fluoroquinolone use.
FDA Warning on Levaquin
FDA in December 2018 issued a warning on the risk of aortic dissection with fluoroquinolone antibiotics, with the risk being greatest in patients with pre-existing heart conditions. The agency added new verbiage to the labeling and prescribing information of fluoroquinolones about the risk of aortic dissection.
“Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available,” FDA said. “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.”
What is Heart Failure?
Heart failure is a life-threatening medical condition in which the heart is unable to pump enough oxygenated blood to meet the body’s requirements, according to the National Heart, Lung and Blood Institute. In some cases, the heart can’t fill with enough blood; in others, the heart can’t pump blood to the rest of the body with enough force to survive.
Heart Failure Symptoms
- Shortness of breath (dyspnea) when you exert yourself or when you lie down
- Fatigue and weakness
- Swelling (edema) in your legs, ankles and feet
- Rapid or irregular heartbeat
- Reduced ability to exercise
- Persistent cough or wheezing with white or pink blood-tinged phlegm
- Increased need to urinate at night
- Swelling of your abdomen (ascites)
- Very rapid weight gain from fluid retention
- Lack of appetite and nausea
- Difficulty concentrating or decreased alertness
- Sudden, severe shortness of breath and coughing up pink, foamy mucus
- Chest pain if your heart failure is caused by a heart attack
Source: Mayo Clinic
- Coronary bypass surgery
- Heart valve repair or replacement
- Implantable cardioverter-defibrillators (ICDs)
- Cardiac resynchronization therapy (CRT), or biventricular pacing
- Ventricular assist devices (VADs)
- Heart transplant
Do I have a Levaquin Heart Failure Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Levaquin lawsuits. We are handling individual litigation nationwide and currently accepting new heart failure cases in all 50 states.
If you or a loved one developed heart failure after taking Levaquin, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.