Levaquin — Fluoroquinolone Antibiotics
Antibiotics are essential medicines that save lives every day. Levaquin is among the most prescribed antibiotics in the country and is used to treat a number of common infections, including bronchitis, sinus infections and urinary tract infections. There are thousands of Levaquin prescriptions filled each year, but the drug and others in its class have been linked to serious and debilitating side effects. These side effects include tears and ruptures in the body’s main artery, tendon damage and severe nerve damage. The FDA has warned about Levaquin’s potential risks and even advised physicians not to prescribe them for common infections unless no other treatment options were available. People who took Levaquin and experienced severe side effects are now filing lawsuits against its manufacturer, Johnson & Johnson’s subsidiary Janssen Pharmaceuticals.
The commonly prescribed antibiotic Levaquin (levofloxacin) has been linked to a number of serious injuries, including aneurysms and tears in the body’s main blood vessel. The FDA is now warning that Levaquin should only be prescribed in cases of serious bacterial infection.
People who were harmed by Levaquin are filing lawsuits against Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson and the manufacturer of Levaquin, seeking compensation for their injuries. There may be significant settlements or cash payouts to those affected by the drug.
If you took Levaquin and experienced an aortic aneurysm or tear in your aorta, you may be able to file a Levaquin lawsuit of your own.
Levaquin lawsuits accuse Janssen of a number of legal claims, including:
- Designing a defective product
- Failing to warn about its risks
Lawyers and attorneys are actively accepting Levaquin cases from claimants nationwide. These lawsuits are being filed individually and are not part of a class action lawsuit. The litigation is still in its early stages. No cases have gone to trial and no settlements or verdicts have been reached.
FDA: Levaquin Risks Outweigh Benefits
Levaquin is a popular antibiotic and one of the most frequently prescribed in the U.S. It is used to treat common illnesses, like sinus infections, bronchitis and urinary tract infections (UTIs).
Levaquin is a potent antibiotic that has been linked to serious and potentially debilitating side effects. These side effects include aortic aneurysms; aortic dissection, or a tear in the aorta; tendonitis or tendon rupture; and severe nerve damage in the arms and legs called peripheral neuropathy.
The risk of Levaquin’s potential side effects prompted the FDA to change its recommendations for the antibiotic and to update its black box warning.
The agency issued safety communications in May and July 2016 warning of Levaquin’s risks. It concluded the drug’s risks did not outweigh its benefits in patients being treated for sinus infections, bronchitis or UTIs.
“We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options … because the risk of these serious side effects generally outweighs the benefits …” the FDA wrote.
An analysis of adverse event reports revealed Levaquin’s side effects could start at any time during treatment, even within hours of taking the first dose. Patients often developed multiple side effects that could last for weeks, months or years; and some side effects, like nerve damage, could be permanent, the FDA warned.
Health care professionals were told not to prescribe Levaquin to patients being treated for uncomplicated sinus and urinary infections or bronchitis if they had other treatment options.
The FDA also updated Levaquin’s black box warning — the FDA’s strongest warning — to address the drug’s risks.
Black Box Warning
In 2008, the FDA added a boxed warning to the Levaquin label, outlining the serious risk of tendinitis or tendon rupture in patients taking the drug.
The agency released a Safety Communication in July 2008 saying patients taking Levaquin or other drugs in its class could experience pain, swelling, inflammation or tears in tendons. These injuries usually happened in the hand, shoulder or the Achilles.
The FDA advised patients to call their doctor if they experienced symptoms like tendon pain, swelling or inflammation, as these could be signs of tendon rupture.
Some patients were at a greater risk for tendon problems when taking Levaquin than others, the FDA warned. This included patients who were over the age of 60, had a kidney, heart of lung transplant, or were undergoing steroid therapy at the same time.
Levaquin’s boxed warning was updated in 2016 after the FDA reviewed adverse event reports and changed its recommendations for the drug. The reports included side effects like tendon rupture, severe nerve damage and aortic aneurysms occurring in otherwise healthy people.
The FDA said Levaquin should be reserved for patients who have no other treatment options because the risk for severe complications outweighed the benefits of using Levaquin for uncomplicated infections, like sinus infections, UTIs and bronchitis.
What is Levaquin?
Levaquin is a popular antibiotic used to treat a variety of different illnesses. Millions of people use antibiotics every year to fight bacterial infections. There were over 260 million oral antibiotic prescriptions filled in U.S. pharmacies in 2014, about 32 million of which were prescriptions for fluoroquinolones like Levaquin.
Antibiotics are lifesaving drugs, but overuse can lead to antibiotic resistance that makes future infections harder to fight. Antibiotics are only effective against bacterial infections — they do not work against viral infections like the flu and the common cold.
Levaquin belongs to a class of antibiotics called fluoroquinolones. These powerful drugs work by targeting specific enzymes in bacteria cells to kill them or stop them from reproducing. Fluoroquinolones are effective in treating many different types of infections.
Levaquin was approved by the FDA in 1996 and is available as an oral tablet, oral solution or injection. Levaquin is approved to treat a number of illnesses and infections, but in light of recent safety concerns, the FDA changed its recommendations for the powerful drug.
Levaquin has been associated with a number of serious and debilitating side effects, including problems in the aorta, the body’s main artery that supplies oxygenated blood to the circulatory system. Levaquin has been shown to cause aortic aneurysms, bulges in the aorta that can possibly rupture, and aortic dissection, tears in the aorta that cause dangerous bleeding.
People who took Levaquin and developed complications are now filing lawsuits against the drug’s manufacturer, Janssen Pharmaceuticals, accusing the company of failing to warn about Levaquin’s potential risks.
Common Uses of Levaquin
Doctors write hundreds of millions of antibiotic prescriptions each year to treat a number of different bacterial infections. Though a relatively large percentage of these are written unnecessarily and contribute to the antibiotic resistance epidemic, there is no doubt antibiotics are essential medicines and when used properly, are effective in treating various infections.
Some of the illnesses Levaquin is used to treat include:
- Sinus infections
- Urinary tract infections (UTI)
- Kidney infections
- Skin infections
- Prostate infections
Serious Side Effects
The FDA has issued several safety communications regarding Levaquin in the past decade, warning about the serious side effects. According to the FDA, these side effects can develop at any time during treatment with Levaquin, some even within hours of taking the first dose.
Some of the most serious side effects associated with Levaquin include:
- Aortic aneurysm
- Aortic dissection
- Peripheral neuropathy
- Tendonitis/tendon rupture
Other rare, but serious side effects are possible when taking Levaquin and include seizures, hallucinations, depression, heart rhythm changes, intestine infection with diarrhea, liver damage, kidney damage, bone marrow damage, and blood sugar changes.
An aortic aneurysm is an abnormal bulge in the wall of the aorta, the main artery that supplies the circulatory system with oxygenated blood. An aortic aneurysm is caused when pressure pushes on a weak spot in the artery. If the aneurysm ruptures, it could cause dangerous bleeding in the body and even lead to death. Every year, about 13,000 people die from aortic aneurysms in the U.S.
Recent studies have shown that fluoroquinolones like Levaquin can lead to aortic aneurysms. Researchers believe Levaquin and other drugs in its class may break down collagen in the body. The lining of the aorta is made up of mostly collagen, which could explain why aneurysms are a possible side effect of Levaquin.
Aortic aneurysms often don’t cause signs or symptoms until they burst, which makes them especially dangerous. A ruptured aneurysm could be fatal.
If a person does experience symptoms of an aneurysm, those symptoms will depend on where the aneurysm is located. The two most common places for an aortic aneurysm to form are in the abdomen and the chest.
Symptoms of abdominal aortic aneurysms include:
- A throbbing feeling in the abdomen
- Deep pain in your back or the side of your abdomen
- Steady pain in your abdomen that lasts for hours or days
Symptoms of an aneurysm that occurs in the chest cavity, called thoracic aortic aneurysms, include:
- Pain in your jaw, neck, back or chest
- Coughing or hoarseness
- Shortness of breath or trouble breathing or swallowing
If an aneurysm ruptures you could experience sudden, sharp, stabbing pain where the burst occurred, nausea and vomiting, light-headedness and rapid heart rate.
Internal bleeding from a ruptured aortic aneurysm can send the body into shock — a life-threatening condition in which blood pressure drops so low vital organs like the brain and kidneys can’t get enough blood to work. Shock can be fatal if it is not treated immediately.
An aortic dissection is a tear that occurs in the lining of the aorta. The tear allows blood to leak in between the layers of the artery and causes potentially dangerous bleeding. A dissection can be fatal if not treated right away.
Symptoms of aortic dissection can mimic those of other serious, yet more common conditions, such as heart attack and stroke.
Aortic dissection symptoms 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
Other Causes of Aortic Aneurysm & Dissection
Aortic aneurysms and dissection are possible side effects of Levaquin and other fluoroquinolones, but other conditions may put people at risk for these problems too.
Other conditions that increase the risk for aortic aneurysm and dissection include:
- Uncontrolled high blood pressure
- Hardening of the arteries
- Marfan syndrome
- Connective tissue disorders
- Inflammation or infections
- Prior aortic aneurysm
Levaquin and other fluoroquinolones have been associated with an increased risk for damaged or ruptured tendons. Tendons connect your muscles to your joints.
The FDA required the makers of Levaquin and other drugs in its class to add a black box warning to their labels in 2008. The agency also issued a safety communication to warn physicians and the public about the potential risk.
Levaquin can affect any tendon in the body, but damage most often occurs in the Achilles tendon, located at the back of the ankle. Some people have a higher risk than others for tendon damage or rupture, including those who are:
- 60 or older
- Undergoing steroid therapy
- Kidney, heart or lung transplant recipients
In its 2008 warning, the FDA told physicians to take patients off of Levaquin at the first sign of tendon pain, swelling or inflammation. The agency said people who experience these signs should also avoid exercise or using the affected area.
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
In 2013, the FDA warned that Levaquin and other fluoroquinolone antibiotics could potentially cause peripheral neuropathy and strengthened warnings on the drugs’ labels. Peripheral neuropathy is severe nerve damage that causes weakness, numbness and pain in the hands and feet.
Peripheral neuropathy can occur at any time during treatment with Levaquin and can last for weeks, months, or years. In some cases, damage can be permanent.
The FDA advised physicians to stop treatment right away if a patient developed signs of the serious condition. Signs and symptoms of peripheral neuropathy include:
- Changes in sensation to light touch, pain or temperature, or the sense of body position
Studies: Risk of Aortic Aneurysm, Dissection
The risks of aortic aneurysm or dissection when taking Levaquin and other fluoroquinolones have been analyzed in recent peer-reviewed studies, including two studies published in the prestigious Journal of the American Medical Association and British Medical Journal.
JAMA Internal Medicine
A study published in JAMA Internal Medicine in November 2015 found Levaquin and other drugs in its class put current users at a two-fold increased risk for aortic aneurysms or dissections.
The study looked at more than 1,400 people who had surgery for an aortic aneurysm or dissection between 2000 and 2011. Researchers looked at current users of fluoroquinolones, those who filled a prescription within 2 months of surgery, and past users, those who filled prescriptions 2 months to 1 year before surgery.
Current use of fluoroquinolones was associated with a two-fold increased risk for aortic aneurysm or dissection, study authors found. Past use was also associated with an increased risk but the risk was lower than that of current use.
A study published in BMJ found patients taking Levaquin or other fluoroquinolones were at an even higher risk of aortic aneurysm than the JAMA study.
The study, also published in November 2015, included more than 1.7 million older adults, about 658,000 of whom took at least one fluoroquinolone antibiotic. Researchers recorded any collagen-related side effects suffered by patients, including tendon ruptures, retina detachments and aortic aneurysms, during the study period.
Researchers found that patients who took Levaquin or another fluoroquinolone were at a nearly three-fold increased for aortic aneurysm compared to patients who did not take a similar antibiotic.
The study authors found that most of the patients who developed an aortic aneurysm did so after about 20 days of taking the drugs.
Other Types of Fluoroquinolones
Levaquin is not the only antibiotic belonging in the fluoroquinolone class. There are currently 6 FDA-approved fluoroquinolones on the market today, including Levaquin, and all 6 carry roughly the same risks of serious side effects.
Other available fluoroquinolones besides Levaquin include:
- Avelox (moxifloxacin)
- Cipro (ciprofloxacin)
- Cipro XR (ciprofloxacin extended release)
- Factive (gemifloxacin)
Alternatives to Levaquin
The FDA recommends that anyone taking Levaquin or another fluoroquinolone should stop treatment and speak with their doctor right away if they experience serious side effects. If there is still an infection to fight, doctors may start treatment with another type of antibiotic.
There are many different kinds of antibiotics on the market today that do not carry the same serious risks of aortic aneurysm and dissection as Levaquin. These other antibiotics may be used to fight the infection instead.
Alternative antibiotics include:
- Penicillins, such as penicillin and amoxicillin
- Cephalosporins, such as Keflex
- Macrolides, such as E-Mycin, Biaxin and Zithromax
- Sulfonamides, such Bactrim and Proloprim
- Tetracyclines, Sumycin, Panmycin and Vibramycin
- Aminoglycosides, such as Garamycin and Tobrex
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FDA Alert. “Information for Healthcare Professionals: Fluoroquinolone Antimicrobial Drugs [ciprofloxacin (marketed as Cipro and generic ciprofloxacin), …” (July 2008). Retrieved from https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm
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FDA Safety Communication. “FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage…” (August 2013). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm365050.htm
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National Heart, Lung, and Blood Institute. “What Are the Signs and Symptoms of an Aneurysm?” (April 1, 2011). Retrieved from https://www.nhlbi.nih.gov/health/health-topics/topics/arm/signs
Mayo Clinic. “Peripheral neuropathy – Symptoms and causes.” Mayo Clinic Staff. (July 7, 2016). Retrieved from http://www.mayoclinic.org/diseases-conditions/peripheral-neuropathy/symptoms-causes/dxc-20204947
EMedicineHealth. “Types of Antibiotics.” (Sept. 16, 2016). Retrieved from http://www.emedicinehealth.com/antibiotics/page2_em.htm
JAMA Internal Medicine. “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone.” Lee CC et al. (November 2015). Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/26436523
BMJ. “Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study.” Nick Daneman et al. (November 2015). Retrieved from http://bmjopen.bmj.com/content/5/11/e010077.long