The antibiotic Levaquin has been associated with an increased risk of aortic aneurysms and peripheral neuropathy, a severe type of nerve damage. The manufacturer is facing hundreds of lawsuits for failing to warn about side effects.
Need a Texas Levaquin Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with nerve damage (peripheral neuropathy), you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
UPDATE: FDA Strengthens Warnings for Levaquin
July 26, 2016 — The FDA has updated labels on Levaquin to warn that the risk of disabling side effects outweighs its benefit for treating minor infections. Risks include tendon problems, muscle and joint pain, nerve damage, confusion, hallucinations, and more. Click here to read more.
FDA: Levaquin Risks Outweigh Benefits for Common Infections
May 2016 — Due to the risk of disabling side effects, the FDA is warning against prescribing Levaquin for people with sinus infections, bronchitis, or uncomplicated urinary tract infections when they have other options. Click here to read more.
The FDA also recommends that patients seek emergency medical attention if they develop severe side effects:
“Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations.”
What is Levaquin?
Levaquin (levofloxacin) is a broad-spectrum antibiotic in the fluoroquinolone class. It is manufactured by Janssen Pharmaceuticals and it has been on the market in the United States since 1996.
What Does Levaquin Treat?
- Community-acquired pneumonia
- Acute bacterial sinusitis
- Acute bacterial exacerbation of chronic bronchitis
- Inhalation anthrax
- Skin and skin structure infections
- Chronic bacterial prostatitis
- Urinary tract infections
- And more
Levaquin and Aortic Aneurysms
Levaquin can damage collagen in connective tissue, which is why it is linked to tendon ruptures and retinal detachment. In October 2015, a study published in JAMA Internal Medicine suggested that Levaquin could also weaken collagen in the wall of the aorta and increase the risk of an aneurysm.
The aorta is the largest blood vessel in the body. Aortic aneurysms occur when the wall of the aorta weakens and bulges outward. In severe cases, it ruptures and causes massive internal bleeding.
Researchers looked at data on nearly 150,000 people in Taiwan who used fluoroquinolone antibiotics like Levaquin. They found a 2.4-fold increased risk of aortic aneurysm among current users of quinolone antibiotics, and a 50% increased risk among past users.
According to researchers:
“Not only is tendon composed of collagen, collagen is also a major extracellular matrix component of the aortic wall. … As fluoroquinolones may induce degradation of collagen causing tendinopathy, this raises the concern that fluoroquinolones may cause or aggravate aortic aneurysm and dissection by a similar mechanism.”
Study Finds Tripled Increased Risk of Aortic Aneurysms
A study published in the British Medical Journal in November 2015 found that current users of fluoroquinolone antibiotics were three times more likely to develop aortic aneurysms. The conclusions of the study were based on data from 18,400 people who had aortic aneurysms after taking fluoroquinolone antibiotics between 1997 and 2012.
Levaquin and Peripheral Neuropathy (Nerve Damage)
Peripheral neuropathy is a type of nerve damage that can occur rapidly (within hours or days) and cause permanent complications. Contact your doctor immediately if you develop symptoms like numbness, tingling, pain, burning or muscle weakness in the arms or legs, or sensory changes (texture, temperature, etc.).
The FDA first warned about the risk of nerve damage from Levaquin in 2004. In 2013, these warnings were updated because the FDA was concerned that warnings did not adequately emphasize the rapid onset of symptoms or permanent complications.
More recently, a study published in Neurology has found that all fluoroquinolone antibiotics, including Levaquin, double a patient’s risk of peripheral neuropathy.
Levaquin Nerve Damage Lawsuits
In August 2015, dozens of lawsuits involving Levaquin-induced nerve damage were centralized into a Multi-District Litigation (MDL No. 2642) in Minnesota. The first lawsuits were filed by victims in Texas, Pennsylvania, Massachusetts, and California. Janssen Pharmaceuticals is now facing hundreds of lawsuits from victims all over the United States.
Studies Links Levaquin and Heart Problems
In March 2014, the Annals of Family Medicine published a study linking the use of Levaquin with a 2.5-fold increased risk of death and a 2.4-fold increased risk of serious cardiac arrhythmia compared to patients receiving amoxicillin for the first 10 days of treatment. Results were based on data from over 200,000 veterans between 1999 and 2012. Click here to read more.
Experts Call for Stronger Warnings
In November 2015, an advisory panel to the FDA discovered nearly 200 cases of Fluoroquinolone-Associated Disability (FQAD) and recommended stronger warnings about side effects of Levaquin.
Experts are also calling on the FDA to add warnings about mitochondrial toxicity and psychiatric side effects to the label for Levaquin and other antibiotics in its class. The risk of neuropathy is particularly serious for people with type-2 diabetes, because diabetes itself is a risk-factor for nerve damage.
Levaquin Black Box Warning
Levaquin carries a boxed warning about the risk of tendon injuries. These injuries primarily affect the Achilles tendon in the heel, but they can occur in any part of the body. Tendons are fibrous tissues that connect the muscles to bones.
According to the Prescribing Information:
“Fluoroquinolones, including LEVAQUIN®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.”
Levaquin Side Effects
The most common side effects of Levaquin include nausea, headache, diarrhea, insomnia, constipation, and dizziness. More serious side effects include:
- Aortic aneurysms
- Tendon pain, swelling, rupture, and inflammation
- Serious allergic reactions
- Swelling of the lips, tongue, face, or throat
- Skin rash
- Liver damage (hepatotoxicity)
- Central Nervous System (CNS) effects
- Intestine infections
- Changes in sensation and nerve damage (peripheral neuropathy)
- Heart rhythm changes
- Joint problems in children
- Low blood sugar (hypoglycemia)
- Sensitivity to sunlight (photosensitivity)
- And more
Levaquin Class Action Lawsuit
In August 2016, a proposed class action (PDF) was filed by a woman from North Carolina who was diagnosed with peripheral neuropathy after taking Levaquin. The case is Rowell v. Johnson & Johnson et al, Case No. 2:16-CV-04369 in the U.S. District Court for the Eastern District of Pennsylvania. Click here to read more.
Need a Levaquin Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Levaquin lawyers for a free lawsuit review.