What is Levaquin?
Manufactured by Ortho-McNeil-Janssen Pharmaceuticals (a Johnson & Johnson company), Levaquin is prescribed to treat bacterial and skin infections, pneumonia and the bubonic plague. Levaquin was approved by the U.S. Food & Drug Administration (FDA) in 1996, and became available as a generic in 2011. Each year, more than 6 million prescriptions are written for oral Levaquin, and over 1 million patients are administered the drug intravenously in a hospital.
Levaquin and Peripheral Neuropathy
Levaquin and other antibiotics in the fluoroquinolone class have recently been linked to peripheral neuropathy. This disorder occurs when nerves between the brain and body become damaged and are unable to effectively communicate with each other. There are over 100 different types of peripheral neuropathy known, depending on which nerves have been damaged.
Symptoms of Neuropathy
- Change in sensation to light touch, pain, or temperature
- Change in sense of body position
- Loss of reflexes
- Muscle wasting
FDA Warning on Levaquin
In August 2013, the FDA issued a Drug Safety Communication which stated that patients treated with fluoroquinolone antibiotics like Levaquin had been diagnosed with peripheral neuropathy. FDA issued the statement because earlier warnings did not adequately describe the potential rapid onset of the disorder. According to the FDA:
“In some patients the symptoms had been ongoing for more than a year despite discontinuation of the fluoroquinolone. Several patients were continued on the fluoroquinolone drug despite the occurrence of neuropathic symptoms.”
Neuropathy Risk Factors
In addition to taking fluoroquinolone antibiotics, the following risk factors may increase your risk of developing peripheral neuropathy:
- Alcohol abuse
- Infections (HIV-AIDS)
- Autoimmune diseases (lupus, rheumatoid arthritis etc.)
- Kidney disease / kidney failure
- Hereditary peripheral neuropathy conditions (Charcot-Marie-Tooth disease)
- Lead poisoning
Fluoroquinolone Antibiotics & Aortic Aneurysm
A study published in JAMA Internal Medicine in Nov. 2015 suggested that fluoroquinolone antibiotics like Levaquin could put users at risk for developing aortic aneurysm or aortic dissection. The researchers noted that fluoroquinolones have been linked to collagen degradation, raising fears the medications may contribute to severe collagen disorders, including aortic aneurysm and dissection. For the study, they 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. “Sensitivity analysis focusing on aortic aneurysm and dissection requiring surgery also demonstrated an increased risk associated with current fluoroquinolone use, but the increase was not statistically significant (propensity score–adjusted RR, 2.15; 95% CI, 0.97-4.60).”
“While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy,” they concluded.
Levaquin Side Effects
- Peripheral neuropathy
- Aortic aneurysm
- Aortic dissection
- Heart failure
- 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
Fluoroquinolone Antibiotics May Cause Fatal Heart Damage, FDA Warns
December 21, 2018 – Fluoroquinolones could increase the risk of an aortic dissection, and people who are already at risk should be cautious about taking these medications, FDA warned in a Drug Safety Communication issued Thursday.
“A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta,” the agency said. “These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.”
Levaquin Settlement Update
April 11, 2017 – Johnson & Johnson has been settling many lawsuits alleging nerve damage and peripheral neuropathy from Levaquin out of court, in some cases just days before trial. It stands to reason that J&J would try to settle as many of the complaints as possible, to avoid a lengthy trial the company would likely lose. Many claimants have already received settlements without ever having to set foot inside a courtroom.
Quinolone Vigilance Foundation
The Quinolone Vigilance Foundation was formed to increase awareness about the dangers of fluoroquinolone antibiotics, and to fund research on the damage caused by the drugs. The group advocates for stronger warnings, and to have fluoroquinolone prescriptions limited to patients with life-threatening infections. Visit the Quinolone Vigilance Foundation for more information about fluoroquinolones and the risks involved with taking them.
Fluoroquinolone MDL Moving Forward in Minnesota
March 22, 2017 – Product liability lawsuits alleging peripheral neuropathy from Levaquin, Cipro and Avelox are moving forward in the U.S. District Court for the District of Minnesota, with at least 10 bellwether cases being prepped for trial. Per a recent update, there are at least 738 lawsuits pending in the fluoroquinolone multidistrict litigation (MDL No. 2642), most of which involve Levaquin.
FDA Strengthens Warnings on Fluoroquinolone Antibiotics
July 27, 2016 – FDA has updated the boxed warnings on fluoroquinolone antibiotics to include information about “disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system” associated with the drugs. The agency cautions that fluoroquinolones should only be used by patients with no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because their potential health risks generally outweigh any benefit.
Hillary Clinton Taking Levaquin to Treat Pneumonia
September 16, 2016 – Hillary Clinton has been taking Levaquin to treat her pneumonia, according to medical records issued this week. Clinton raised concerns when she appeared to struggle while walking after a 9/11 ceremony. Some believe this behavior may have been caused by an adverse drug reaction rather than by her medical condition.
Arkansas Man Alleges Serious Side Effects From Levaquin
June 27, 2016 – Arkansas resident John Reed is suing Bayer, Merck, Johnson & Johnson and Janssen Pharmaceuticals, alleging permanent injuries from Levaquin and Avelox (generic: moxifloxacin). Reed claims that he suffered serious side effects including irreversible peripheral neuropathy after taking the drugs in 2008, and blames the manufacturers for failing to adequately warn about the potential health risks associated with their use. The complaint was filed May 27 in the U.S. District Court for the Eastern District of Pennsylvania under case number 2:16-cv-02615-GAM.
FDA Issues New Warning on Levaquin
May 12, 2016 – The FDA is requiring new warnings to be added to the labeling of Levaquin and other fluoroquinolone antibiotics regarding an increased risk for damage to muscles, nerves and more. Specifically, the agency is calling for an updated boxed warning to inform patients that the risks of fluoroquinolones may outweigh the benefits in patients with sinusitis, bronchitis and uncomplicated urinary tract infections.
Mother Blames Levaquin for Son’s Death
April 26, 2016 – An Indiana woman is calling for changes at the national level after losing her son to what she believes was a Levaquin-induced death, according to ABC News. Purdue University freshman Shane McCarthy was prescribed a 30-day supply of Levaquin before undergoing surgery for a deviated septum, a minor procedure. Shortly after starting the drug, McCarthy began acting erratically, ultimately culminating in his death after jumping from a 2nd story window and driving his car into a cement embankment on October 23, 2013.
Are Levaquin Lawsuits Being Filed?
J&J is currently facing thousands of product liability lawsuits filed by people who allegedly developed peripheral neuropathy, irreversible nerve damage and other serious side effects after taking Levaquin. The complaints allege that Ortho-McNeil did not provide adequate warnings about the drug’s potential to cause these conditions. According to the FDA, over 60% of fluoroquinolone-induced tendon injuries have been linked to Levaquin.
Do I Have a Levaquin 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 investigating potential settlements in all 50 states.
Again, if you were injured by Levaquin side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.