The antibiotic drug Levaquin (levofloxacin) has recently been linked to serious side effects including nerve damage, peripheral neuropathy, Stevens-Johnson syndrome (SJS) and aortic aneurism.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by Levaquin, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: 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.
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 received clearance from the 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 separate and distinct forms of peripheral neuropathy known, depending on which nerves have been damaged. In general, however, symptoms of neuropathy may include:
- Change in sensation to light touch, pain, or temperature
- Change in sense of body position
- Loss of reflexes
- Muscle wasting
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 Aneurism
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 aneurism
- Aortic dissection
- 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
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.
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 U.S. Food & Drug Administration (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 (UTIs). Side effects of these drugs may include damage to tendons, muscles, joints, nerves and the central nervous system, according to the FDA.
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.
“It was a moment, I believe, of sheer agitation and anxiety and I believe it overcame him,” Shane’s mother Heather McCarthy said. “Everything just collapsed for our family. It was just a nightmare.”
Lawsuit Alleges Former FDA Chief Hid Dangers of Levaquin for Sake of Profits
April 25, 2016 – Former FDA Commissioner Margaret A. Hamburg, her hedge fund executive husband, and Johnson & Johnson (J&J) conspired to increase profits by failing to warn about the “deadly” antibiotic Levaquin, according to a federal racketeering lawsuit (case 1:16-cv-00086-RJL) filed Jan. 11 in the U.S. District Court for the District of Columbia. The complaint was filed on behalf of 5 individuals who claim they suffered severe physical harm as a result of taking the drug.
“Once confirmed as FDA commissioner, Dr. Margaret A. Hamburg acted as the instrumentality that all defendants used to perpetrate their conspiracy and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA commissioner to suppress material information to plaintiffs and the public that Levaquin was inherently dangerous and in fact, deadly,” the suit alleges. “Had this information been disclosed to plaintiffs and the public at large, her and her husband’s financial gain and net worth would have plummeted, since Dr. Margaret A. Hamburg’s husband, Peter F. Brown, reaped and continues to reap huge financial gain as a result of Renaissance Technologies, L.L.C.’s holdings of Johnson & Johnson stock.”
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 Product Liability & Defective Drug 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.
Free Confidential Case Evaluation: 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.