Antibiotics are among the most important medical discoveries in human history. The advent of antibiotics during the 20th century revolutionized modern medicine and led to the quick treatment of infections that were once considered deadly. But rampant overuse of the revolutionary medicine has led to antibiotic-resistant superbugs; and overuse of one of the most popular antibiotics in the past two decades has exposed thousands of people to serious potential side effects associated with the drug, including damage to the aorta, the body’s main artery.
What is Levaquin?
Levaquin is the brand-name of a popular prescription antibiotic medication used to treat common bacterial infections. The main ingredient in Levaquin, levofloxacin, belongs to a class of drugs called fluoroquinolones. Levaquin and other fluoroquinolones are among the most-prescribed antibiotic medicines in the United States, with over 26 million people prescribed one of six currently available fluoroquinolones annually.
What is Levaquin used to treat?
Levaquin is indicated to treat many common ailments, including sinus infections, ear infections, pneumonia and urinary tract infections (UTIs). Like all antibiotics, Levaquin is only effective in treating bacterial infections. Illnesses such as the common cold, the flu and other infections caused by viruses cannot be cured with antibiotics.
How does Levaquin work?
Levaquin’s main ingredient, levofloxacin, works by targeting certain enzymes within bacteria cells necessary in the DNA replication process. Levaquin inhibits the enzymes DNA gyrase and topoisomerase IV, which aid in DNA replication and make cell division possible. Interfering with these enzymes interferes with the bacteria’s ability to survive.
Bacteria are classified as either gram-positive or gram-negative bacteria. Gram-positive bacteria lack an outer membrane and are more susceptible to antibiotics. Levaquin’s mechanism of action (MOA) is such that it is active against both gram-positive and gram-negative bacteria. This means Levaquin is effective in treating many different types of infections.
Despite its effectiveness in killing bacteria, overuse of Levaquin can lead to bacterial resistance. When bacteria become resistant to Levaquin, the drug becomes less effective. Resistance to Levaquin and other fluoroquinolone antibiotics can evolve rapidly.
Who makes Levaquin?
Levaquin is manufactured by Johnson & Johnson’s pharmaceutical unit Janssen Pharmaceuticals. J&J and its 250 subsidiaries manufacture and market consumer goods, medical devices and pharmaceutical drugs throughout the world. In 2015, J&J brought in over $70 billion in global sales.
When was Levaquin approved by the FDA?
Levaquin was approved by the Food and Drug Administration (FDA) on December 20, 1996.
The antibiotic drug was originally approved to treat certain sinus infections, bronchitis, pneumonia, skin infections, urinary tract infections (sometimes called bladder infections) and kidney infections.
Its use was later expanded to include the treatment of prostate infections, infections caused by anthrax and plague.
What other fluoroquinolone antibiotics are available?
There are six fluoroquinolone antibiotics available on the US market today, including:
- Avelox (moxifloxacin)
- Factive (gemifloxacin)
- Levaquin (levofloxacin)
- Cipro (ciprofloxacin)
- Cipro extended release
- Moxifloxacin injection
What are the possible side effects of Levaquin?
Levaquin carries the risk of certain side effects, some of which can be serious and life-threatening. Levaquin carries a black box warning on its label regarding some of the possible adverse effects, including the risk of tendonitis and tendon rupture.
According to the drug’s package insert, the most common side effects of Levaquin include:
Other side effects are also possible, including more serious side effects such as:
- Serious allergic reactions – hives, trouble breathing or swallowing, swelling of the lips, tongue or face, rapid heartbeat, throat tightness and hoarseness, faint, skin rash
- Tendonitis and tendon rupture
- Nerve damage called peripheral neuropathy
- Liver damage (hepatoxicity)
- Central nervous system effects, including seizures and persistent headaches
- Intestine infections (Pseudomembranous colitis)
- Serious heart rhythm changes
- Joint problems in children, including joint damage and joint pain
Some of these side effects can occur immediately after taking the first dose of Levaquin, including central nervous system effects, while others can occur months after taking the drug, including tendonitis and tendon rupture.
What is an aortic aneurysm?
Aortic aneurysm is a potentially life-threatening side effect of Levaquin and can be life-threatening if not treated right away.
An aortic aneurysm is an abnormal bulge in the wall of the aorta, the body’s main artery responsible for carrying oxygenated blood to all parts of the body except the lungs. When a weak area in the aorta exists, it can allow the pressure within the artery to push outward and create a bulge or ballooned area.
When an aneurysm ruptures it is considered a catastrophic, life-threatening event.
Aneurysms can occur in any blood vessel in the body, but most often occur in the aorta. The two most common areas in the aorta to form an aneurysm are in the abdomen and the chest cavity. Aneurysms put people at risk for:
- Plaque formation in the artery at the site of the aneurysm
- Blood clots
- Increased size of aneurysm, causing it to press on another organ causing pain
- Rupture, due to weakening of the artery walls
Aortic aneurysms are not often accompanied by symptoms. When they are present, symptoms can include:
- Tearing pain in the chest, abdomen, or middle of the back between the shoulder blades
- Aneurysms in the chest cavity can cause shortness of breath, hoarseness, cough and difficulty swallowing
- A rupture can cause loss of consciousness, stroke, shock or heart attack
What is an aortic dissection?
Aortic dissection is a possible side effect of Levaquin and can be fatal if not treated promptly.
Aortic dissection is a rare, but often fatal condition that occurs when the inner lining of the aorta tears. When it tears, blood surges through the opening, causing the inner and middle layers of the aorta to separate, or dissect. If the dissection ruptures, it can be fatal.
Symptoms of aortic dissection can mimic those of other diseases. This can often delay diagnosis. An aortic dissection that is caught early and treated promptly significantly improves a person’s chances of survival.
Symptoms of an aortic dissection include:
- Sudden, severe chest or upper back pain
- Loss of consciousness
- Shortness of breath
- Sudden difficulty speaking, loss of vision, weakness or paralysis on one side of the body
- Weak pulse in one arm compared to the other
How does Levaquin cause damage to the aorta?
Levaquin has been linked to two types of damages to the aorta: aneurysm and dissection. Researchers suggest Levaquin may affect collagen composition in the body. Collagen makes up the majority of the lining of the aorta.
Two recent studies published in the November 2015 editions of JAMA Internal Medicine and BMJ linked Levaquin to these risks.
The JAMA Internal Medicine study found patients taking Levaquin, or another fluoroquinolone antibiotic, in the last 60 days were at a two-fold increased risk for aortic aneurysm or dissection.
Patients taking the antibiotics in the past 61 days to one year were also at an increased risk, though their risk was slightly lower than current users.
The BMJ study found patients taking Levaquin, or other fluoroquinolone antibiotics, were at a nearly three-fold increased risk of aortic aneurysm or dissection.
The study, which looked at 1.7 million older adults, said most patients who developed an aortic aneurysm or dissection did so after about 20 days of taking the medication.
The study also talked about the overprescribing of antibiotics in the United States, which can be especially dangerous when those antibiotics carry risks of serious side effects.
According to the study authors, “reducing unnecessary fluoroquinolone treatments or prolonged treatment courses might have possibly prevented more than 200 aortic aneurysms in this population.”
Has the FDA issued any warnings about Levaquin?
The FDA has issued numerous warnings about Levaquin since it was first approved in the late 1980s. Most of the warnings are in regard to the drug’s possible side effects, some of which can be serious and lead to death.
Black box warnings
In 2008, the FDA required the makers of Levaquin and other fluoroquinolone antibiotics to include a black box warning on the drugs’ labels, warning patients of the risk of tendonitis and tendon rupture.
Levaquin increases a person’s risk for tendon damage or rupture. While this can affect any tendon in the body, it most often occurs in the Achilles tendon.
The agency said the risk for tendon damage or rupture can affect anyone taking Levaquin, but the risk is greater for those over 60, who are using steroidal medications, or who have had a lung, kidney or heart transplant.
Symptoms of a damaged or ruptured tendon include:
- Pain, swelling or inflammation
- A snap or pop in the tendon area
- Bruising right after injury in a tendon area
- Inability to move the affected area or bear weight
Levaquin’s black box warning also includes the risk of exacerbated muscle weakness in people with myasthenia gravis, a condition that affects the communication between nerves and muscles.
In 2013, the FDA issued a safety communication regarding the risk of peripheral neuropathy while taking Levaquin and other fluoroquinolones.
Peripheral neuropathy is severe nerve damage occurring in the arms or legs. The agency warned it could occur at any time while taking Levaquin and could last for days or months after stopping the medication. For some people the symptoms could be permanent, the agency would later warn.
Symptoms of peripheral neuropathy include:
- Change in sensation to light touch, pain or temperature, of sense of body position
Levaquin’s benefits don’t outweigh risks
Recently, in May 2016, the FDA issued a warning about Levaquin and other fluoroquinolones saying the drugs’ serious side effects do not usually outweigh the benefits for patients being treated for uncomplicated UTIs, sinus infections and bronchitis.
The agency’s safety communication warned fluoroquinolones, including Levaquin, are “associated with disabling and potentially permanent serious side effects that can occur together. These side effects involve the tendons, muscles, joints, nerves and central nervous system.
The agency said people being treated for the common illnesses mentioned above should not take Levaquin or any other fluoroquinolone unless no other treatment option is available.
Levaquin’s black box warning will soon be updated to include this new warning.
Has Levaquin been recalled?
Levaquin has not been recalled by the FDA in regard to its possible serious side effects.
Are there generic versions of Levaquin available?
Levaquin is available as a generic sold under the generic name levofloxacin. Generics are generally cheaper than their brand-name counterparts, and can be sold through various different pharmaceutical companies.
How do you take Levaquin?
Levaquin can be taken orally or given intravenously (IV). Levaquin is usually given intravenously in a hospital setting.
When taken orally, Levaquin is available in 250 mg, 500 mg and 750 mg pills and as a 25 mg/mL liquid suspension. The dosage usually depends on the infection being treated and the patient’s age.
Renal dosing: Patients with kidney problems, including kidney failure, are usually given a lower dose of Levaquin.
Levaquin oral tablets can be taken with or without food; Levaquin oral solution should be taken 1 hour before or 2 hours after eating.
Reversible renal (kidney) toxicity has been reported in acute overdoses of Levaquin. Seek emergency medical help or call the Poison Help line at 1-800-222-1222 immediately after a suspected Levaquin overdose.
What should I avoid while taking Levaquin?
Levaquin is contraindicated in people taking the muscle relaxant tizanidine (sold under the brand name Zanaflex) or who have an allergy to Levaquin or any member of the quinolone class of antibiotics.
Levaquin can also interact with certain drugs and vitamins and minerals.
Supplements/products to avoid
Antacids – Antacids that contain magnesium or aluminum, such as Maalox, Mylanta and Rolaids, and the ulcer medicine sucralfate (Carafate) should be taken at least two hours before or two hours after taking Levaquin.
Vitamins or mineral supplements – Vitamins or mineral supplements that contain iron or zinc should be taken at least two hours before or two hours after taking Levaquin.
Didanosine (Videx) powder or chewable tablets should be taken two hours before or two hours after taking Levaquin.
Other things to avoid
Sunlight or tanning beds – Levaquin may make your skin burn more easily.
Driving – Levaquin can impair your thinking and reactions. It is important to be careful if you drive or do anything that requires you to be alert.
Other possible interactions
Birth control – Some antibiotics can interact with certain forms of birth control (contraception) and may make them less effective, raising a person’s risk for unintended pregnancy. Levaquin is not usually associated with this kind of effect on birth control.
Who should not take Levaquin?
Levaquin is not safe to use in all patients. The following patients may want to avoid taking Levaquin or speak with their doctor before taking the medication.
Patients with myasthenia gravis – People with a muscle disorder known as myasthenia gravis should not take Levaquin as it can exacerbate muscle weakness.
Diabetic patients taking an anti-diabetes medicine – Levaquin may cause changes in blood sugar in patients with diabetes taking an anti-diabetic medicine. You may need to take another antibiotic medicine if your blood sugar drops too low.
Pregnant women – Levaquin is a pregnancy category C drug, meaning there are no adequate and well-controlled studies in pregnant women to show it is safe to use during pregnancy. Women who are pregnant should speak with their doctor before taking Levaquin to see if the drug’s benefits outweigh the possible risks.
Nursing mothers – Levaquin can pass through breast milk from mother to baby. Because of the drug’s possible side effects, a decision should be made whether or not to continue breastfeeding or taking Levaquin based on the mother’s need for the drug.
Children – Levaquin increases a child’s risk of developing musculoskeletal disorders, such as arthralgia, arthritis, tendinopathy and gait abnormalities, compared to other non-fluoroquinolone antibiotics.
Are there lawsuits against the maker of Levaquin?
Previous class action and individual lawsuits have been filed against the makers of some fluoroquinolone antibiotics due to the drugs’ possible side effects of tendon rupture and peripheral neuropathy.
With recent studies linking the antibiotic medications, including Levaquin, to aortic aneurysms and dissections, new lawsuits are being filed in 2016 by those harmed by the popular drugs.
As of July 2016, no settlements have been reached in any Levaquin Aortic Aneurysm Lawsuit.
I took Levaquin and suffered an aortic aneurysm. Can I file a lawsuit?
The Hood National Law Group is currently investigating cases for a potential lawsuit against the makers of Levaquin, Johnson & Johnson’s Janssen Pharmaceuticals.
Other lawsuits are possibly forming against the makers of other popular fluoroquinolone antibiotics, including Cipro.
If you or someone you love took Levaquin and suffered from an aortic aneurysm or dissection, you may be entitled to financial compensation. Not sure if you have a case? Call us today to speak with a member of our legal team. We can answer your questions and help you determine if your case qualifies for a possible lawsuit.
Call the Hood National Law Group today at 1-800-214-1010, or use the form on the right hand side of your screen.