Levaquin (levofloxacin), an antibiotic created by Janssen Pharmaceuticals, now a unit of Johnson & Johnson, is sold by Johnson & Johnson and Ortho-McNeil, Levaquin has been linked to life-altering injuries, including hundreds of cases of serious tendon injuries and tendon ruptures, and a serious, sometimes fatal disorder that may cause serious injury to the skin and mucus membranes known as Stevens-Johnson Syndrome (SJS).
Levaquin was approved by the U.S. Food and Drug Administration (FDA) in 1996 and is a member of the fluoroquinolone family of antibiotics, -a subset of quinolone drugs and a third-generation fluoroquinolone. Levaquin was approved for the treatment of bacterial infections of the lungs, including bronchitis and pneumonia; infections of urinary tract and skin; and treatment of the bubonic plague, anthrax. Levaquin has been available in generic form since 2011 and is prescribed to some six million people in oral form (250, 500, and 750 mg tablets) annually; one million people receive intravenous (IV) (500 mg) Levaquin in hospitals, making it the second most popular drug in its class and the best-selling antibiotic in the United States in 2010.
Parker, Waichman LLP attorneys are currently offering free Levaquin lawsuit evaluations to individuals allegedly injured by Levaquin. While the association between Levaquin and serious side effects has been known for many years, Johnson & Johnson and Ortho-McNeil have represented this drug as a safe antibiotic. In fact, the companies have continued to do so even though it is known that many other antibiotics are far safer and just as effective as Levaquin.
FDA Panel Calls for Stronger Warnings for Levaquin; Levaquin Tendon Damage Black Box Warning Ultimately Implemented
In 2008, the U.S. Food and Drug Administration’s (FDA) finally forced Johnson & Johnson and Ortho-McNeil to place a strong Black Box warning on the label of Levaquin regarding its link to tendon damage, especially ruptures of the Achilles tendon. But this warning came too late for scores of people. Because the companies did not adequately warn patients and their doctors about these potential Levaquin side effects, thousands of people needlessly suffered debilitating injuries. In many instances, Levaquin tendon ruptures allegedly required victims to undergo surgery and extensive rehabilitation. Even following such treatment, many Levaquin users never completely recovered from their tendon injuries.
The FDA’s Antimicrobial Drugs Advisory Committee (ADMAC) and the Drug Safety and Risk Management Advisory Committee met jointly on November 5, 2015 to discuss the use of fluoroquinolone antibacterial drugs, such as Levaquin, for treatment of acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis in those with chronic obstructive pulmonary disease (ABECB-COPD), and uncomplicated urinary tract infection, Medscape Multispecialty reported.
Fluoroquinolone labeling carries warnings about the risks for tendonitis, tendon rupture, central nervous system effects, peripheral neuropathy, myasthenia gravis exacerbation, QT prolongation and Torsades de Pointes, phototoxicity, and hypersensitivity. Regardless, panel members called for stronger wording, with some suggesting these risks be highlighted with a Black Box warning, the FDA’s strongest warning. These adverse effects have been seen in larger numbers of patients since the FDA approved fluoroquinolone drugs, such as Levaquin. In fact, more than 30 individuals spoke at an open public hearing about their experiences with these effects; many said they had lost years of their lives, according to Medscape.
The panel voted overwhelmingly that the benefits and risks for the fluoroquinolone antibacterial drugs do not support the current labeled indications for the treatment of ABS, ABECB-COPD, or uncomplicated urinary tract infection. For moderate to severe ABECB-COPD, the treatment effect of antibacterial therapy is robust; antibacterial treatment is recommended in these patients, who are often hospitalized.
The personal injury lawyers at Parker Waichman are currently representing individuals suffering due to alleged injuries associated with Levaquin and many Levaquin lawsuits are pending in courts throughout the country.
|Quick Facts: Levaquin Reference Guide|
|Date Approved||December 20, 1996|
|Status||On the market|
|Serious Side Effects||Peripheral Neuropathy
Abdominal or stomach pain
Federal Regulators Announce Fluoroquinolone Warnings Not Sufficient for Certain Infections According to Committee Findings
The FDA’s Antimicrobial Drugs Advisory Committee met in November 2015 and found that fluoroquinolones did not carry adequate safety warnings for treating specific infections such as sinus infections, infections tied to chronic bronchitis, and urinary tract infections (UTIs). The Committee was focused on the potential risks of fluoroquinolones, which agency staff indicated might include tendons inflammation and tearing and peripheral neuropathy, a condition caused by nerve damage and may affect the body’s extremities.
The Committee voted 21 to 0 that fluoroquinolone antibacterial drugs, which include Levaquin, do not contain adequately strong labeling for the treatment of acute bacterial sinusitis, the Committee voted 18 to 2 that fluoroquinolone labeling is insufficient for the treatment of acute bacterial problems that complicate chronic bronchitis in people diagnosed with chronic obstructive pulmonary disease (COPD), and 20 to 1 that labeling does not carry sufficient warnings for the treatment of UTIs, according to confirmation by FDA spokeswoman Lyndsay Meyer who said, “This meeting provided valuable information and perspectives to help inform the FDA’s decision-making processes.” Ms. Meyer adding that, “The FDA plans to consider the input from committee members and the public from the advisory committee meeting and determine what future actions may be appropriate.”
Also, a Belgian doctor first established a link between the fluoroquinolones and permanent nerve damage in 1992. In 2002, according to Law360.
Federal Regulators Warn that Fluoroquinolone Antibacterial Medications, Such as Levaquin, be Restricted for Specific Infections
In May 2016, the FDA issued a warning indicating that the serious and significant effects tied to fluoroquinolone antibacterial drugs, including Levaquin, typically outweigh the benefits of these drugs for patients diagnosed with sinusitis, bronchitis, and uncomplicated UTIs who have other treatment options for these infections. Fluoroquinolones, such as Levaquin, should not be taken by patients diagnosed with any of these conditions unless they have no other alternative treatment options.
The FDA safety review found that when fluoroquinolones are used systemically, which means taken in tablet, capsule, and injectable forms, they are tied with potentially disabling and potentially permanent serious side effects that may occur together and may involve tendons, muscles, joints, nerves, and the central nervous system. The FDA now mandates drug labels and “Medication Guides” for all fluoroquinolone antibacterial drugs-including Levaquin-be updated to reflect the new safety information.
Levaquin Subject of a Prior Black Box Warning
All fluoroquinolone antibiotics, including Levaquin, have been linked to serious tendon ruptures; however, Levaquin is the one most commonly associated with this side effect. By 2008, the FDA’s database revealed 262 reported cases of tendon ruptures, 259 cases of tendinitis, and 274 cases of other tendon disorders associated with these drugs. The majority of tendon ruptures-61 percent-were tied to Levaquin.
Many patient advocates spent years pushing for stronger Levaquin warnings. In August 2006, the consumer advocacy group, Public Citizen, and the Illinois Attorney General petitioned the FDA to add a Black Box warning to Levaquin’s packaging regarding the increased risk of tendon rupture. The petition also asked the agency to require that patients be given FDA-approved medication guides that would also warn of tendon ruptures associated with Levaquin.
In July 2008, the FDA finally directed Johnson & Johnson and Ortho-McNeil to add a Black Box warning to Levaquin’s label regarding its association with tendon damage. According to the FDA, pain, swelling, inflammation, and tears of the tendons, including the Achilles, shoulder, hand, or others, may occur in patients taking Levaquin.
For individuals taking Levaquin, there should be awareness that tendon ruptures and other tendon injuries are associated with this drug. Patients are encouraged to seek immediate medical attention any of the following symptoms occur:
- A snap or pop in a tendon area
- Bruising right after an injury in a tendon area
- The inability to move the affected area or bear weight
- Pain, swelling, or inflammation in a tendon area
Levaquin tendon injuries are likelier to occur in people who are over 60 years of age; taking steroids (corticosteroids); or who have undergone a kidney, heart, or lung transplant. The most common tendon injury associated with Levaquin involves rupture of Achilles tendon, which may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, and the thumb have also been reported. Tendon rupture may occur during or after completion of a course of Levaquin, although cases occurring up to several months after completion of therapy have been reported.
Levaquin Found to be Associated with Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrosis
SJS and toxic epidermal necrosis (TEN) are life threatening skin conditions that have been associated with Levaquin. Both disorders are often caused by severe reactions to drugs. SJS and TEN may start with mild non-specific symptoms such as fever, malaise, chills, aching muscles, headache, sore throat, or stinging eyes.
In SJS, a person will likely experience blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash. With TEN, which is a more severe form of SJS, there is a similar blistering of mucous membranes; however, in addition to blistering, the entire epidermis typically peels off in sheets from large areas of the body.
The mortality rate for persons suffering with SJS is between 25 and 80 percent. Some of the factors that determine a person’s likelihood of survival include the severity of the disorder and the amount of skin that the victim loses. If a person with SJS has lesions that are exposed and become infected, they have a much higher chance of dying.
To save the life of a person with SJS or TEN, treatment usually includes antibiotics; intravenous immunoglobulin (IVIG); pain medication; and, in the most severe cases, skin grafts. Often, patients diagnosed with SJS or TEN are treated in the hospital’s burn unit.
Because SJS and TEN are so dangerous, Levaquin patients and their caregivers must be aware of their symptoms so they know when to seek medical attention. It is important to seek medical care and discontinue use of Levaquin if these disorders develop.
Levaquin Associated with Peripheral Neuropathy
Levaquin has also been associated with peripheral neuropathy (nerve damage) and, in 2013, the FDA published new warnings concerning these risks. The serious nerve damage tied to Levaquin may occur within a few days, or over time-weeks or years-causing permanent disability and chronic pain. In some cases, chronic neuropathy may worsen.
In September 2004, federal regulators issued a warning concerning Levaquin and its potential increased risks for peripheral neuropathy. In August 2013, the agency issued another warning. The warnings were issued because the original warnings allegedly did not fully explain the risk of rapid onset and potentially permanent neuropathy associated with Levaquin. The FDA wrote that, “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.”
Researchers have been aware of the neuropathy risks associated with Levaquin as far back as 2001. In fact, a study on these risks was published in the Annals of Pharmacotherapy.
Peripheral neuropathy affects some 20 million Americans, according to the National Institutes of Health (NIH) and occurs when peripheral nervous system damage-injury, illness, exposure to toxic drugs-takes place between the body and the brain, which leads to paresthesia in the arms and legs. Also according to the NIH, because of the many types of nerves that are potentially involved, there are over 100 types of peripheral neuropathy, with some leading to significant, chronic, difficult-to-treat pain.
Peripheral neuropathy may lead to general numbness, weakness of the muscles, and coordination problems, all of which may lead to issues walking, balance, and even small motor skills. The damage may cause confusion and interference with the brain’s messaging to the body, which creates serious issues in the way in which an individual feels-or does not feel-sensation. For example, a patient may feel severe pain to sensations that are not typically associated with any pain at all. The nerves in the hands and feet are generally the first to be affected. Symptoms may include:
- Burning, burning pain at night
- Change in sensation to light touch, pain, temperature, sense of body position
- Digestive issues
- Loss of reflexes
- Muscle wasting
- Organ, gland dysfunction
- Poor bowel control
- Poor sexual function
- Sweating, lack of sweating
Because nerves have limited regeneration capacity, cells that have not died may slowly regenerate; however, treatments are only able to cease neuropathy’s progression and do not cure existing damage, leaving some patients forced to rely on a cane, crutches, braces, or a wheelchair.
Levaquin Side Effects Injury Lawsuit
Our Levaquin injury lawyers believe that Johnson & Johnson and Ortho-McNeil waited far too long to issue adequate warnings about this drug’s association with a growing variety of serious adverse reactions. As a result, potentially thousands of people were needlessly put at risk for debilitating tendon injuries, SJS, TEN, and other significant injuries. This negligence is particularly galling, considering there are many safer alternatives to Levaquin.
Levaquin is an Expensive Antibiotic.
Not only is Levaquin associated with an array of serious side effects, a full course of Levaquin treatment may cost as much as $100. In fact, there are many other antibiotics-including some generic versions-that cost patients far less, and are much safer. Yet, through their marketing efforts, Johnson & Johnson and Ortho-McNeil persuaded doctors that Levaquin offered patients some advantage over less costly alternatives. In light of Levaquin’s serious side effects, few people continue to believe the benefits of the drug outweigh its risks.
Legal Help For Victims Affected By Levaquin
Patients who have used Levaquin and suffered a tendon rupture or other tendon injury, SJS, TEN, or other injury may be eligible to file a Levaquin lawsuit.
Parker Waichman offers free case evaluations for anyone who developed serious injuries while taking Levaquin, or following Levaquin treatment. Please complete the online form or call
1-800-YOURLAWYER (1-800-968-7529) as soon as possible to discuss a potential case with one of our Levaquin injury lawyers today.