Levaquin Injuries

Synopsis of Prescription Drug Litigation

Levaquin is prescribed for bacterial infections of the lungs, urinary tract, and skin. In 2008, the Food & Drug Administration (FDA) required that the labeling of Levaquin and other fluoroquinolone antibiotics be revised to include a Black Box warning about tendon injuries. At the time, the FDA database showed 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. The agency said such injuries were more likely to occur in people who are over 60 years of age, taking steroids (corticosteroids), or who have undergone a kidney, heart, or lung transplant. Johnson & Johnson has been ordered to pay $1.8 million to an elderly man who said the antibiotic caused him to suffer a tendon rupture. The trial was the first of more than 2,600 lawsuits making similar claims about Levaquin

Levofloxacin is associated with a number of serious and life-threatening adverse reactions as well as spontaneous tendon ruptures and irreversible peripheral neuropathy. Such reactions may manifest long after therapy had been completed and in severe cases may result in life-long disabilities. Hepatoxicity (liver toxicity) has also been reported with the use of levofloxacin.

Levaquin® (Levofloxacin): Manufactured by Johnson and Johnson (J&J) and approved by the FDA in 1996. Levofloxacin is a second generation quinolone antibiotic that accounted for over $1.6 billion in sales for J&J in 2007.

Why is this medication prescribed?: Levofloxacin is used to treat certain infections such as pneumonia chronic bronchitis and sinus, urinary tract, kidney, prostate (a male reproductive gland), and skin infections. Levofloxacin is also used to prevent anthrax (a serious infection that may be spread on purpose as part of a bioterror attack) in people who may have been exposed to anthrax germs in the air. Levofloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics will not work for colds, flu, or other viral infections.

FDA indications: Levaquin is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible strains of certain microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy

What you should know before taking Levaquin:
Levofloxacin comes as a tablet and a solution (liquid) to take by mouth. It is usually taken once a day. The length of your treatment depends on the type of infection you have. Your doctor will tell you how long to take levofloxacin. The tablet may be taken with or without food. The solution should be taken 1 hour before or 2 hours after eating. Take levofloxacin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take levofloxacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You should begin to feel better during the first few days of treatment with levofloxacin. If your symptoms do not improve or if they get worse, call your doctor.

Take levofloxacin until you finish the prescription, even if you feel better. Do not stop taking levofloxacin unless you experience the symptoms of tendinitis or tendon rupture described in the IMPORTANT WARNING section or the symptoms of allergic reaction described in the SIDE EFFECTS section of your drug monograph or patient package insert. If you stop taking levofloxacin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What special precautions should I follow when taking Levaquin?

• tell your doctor and pharmacist if you are allergic or have had a severe reaction to levofloxacin; any other quinolone or fluoroquinolone antibiotic such as ciprofloxacin (Cipro), gatifloxacin (Tequin) (not available in the US), gemifloxacin (Factive), lomefloxacin (Maxaquin) (not available in the US), moxifloxacin (Avelox), nalidixic acid (NegGram), norfloxacin (Noroxin), ofloxacin (Floxin), and sparfloxacin (Zagam) (not available in the US): or any other medications, or if you are allergic to any of the ingredients in levofloxacin tablets or solution. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); certain antidepressants; antipsychotics (medications to treat mental illness); cyclosporine (Gengraf, Neoral, Sandimmune); diuretics ('water pills'); insulin; oral medications for diabetes such as glyburide (DiaBeta, in Glucovance, Micronase, others); certain medications for irregular heartbeat such as amiodarone (Cordarone), procainamide (Procanbid), quinidine, and sotalol (Betapace, Betapace AF, Sorine); nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Naprosyn, others); tacrolimus (Prograf); or theophylline (Elixophyllin, Theo-24, Uniphyl, others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking antacids containing aluminum hydroxide or magnesium hydroxide (Maalox, Mylanta, Tums, others), didanosine (Videx), sucralfate (Carafate), or vitamin or mineral supplements that contain iron or zinc, take these medications 2 hours before or after you take levofloxacin.
• tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or an irregular heartbeat, and if you have or have ever had nerve problems; a low level of potassium in your blood; a slow heartbeat; cerebral arteriosclerosis (narrowing of blood vessels in or near the brain that can lead to stroke or mini-stroke); seizures; chest pain; or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking levofloxacin, call your doctor.
• you should know that levofloxacin may cause confusion, dizziness, lightheadedness, and tiredness. Do not drive a car, operate machinery, or participate in activities requiring alertness or coordination until you know how this medication affects you.
• plan to avoid unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds and sunlamps) and to wear protective clothing, sunglasses, and sunscreen. Levofloxacin may make your skin sensitive to sunlight or ultraviolet light. If your skin becomes reddened, swollen, or blistered, like a bad sunburn, call your doctor.

Black Box Warning:

Lawsuits: STATUS OF LEVAQUIN LITIGATION: All federal Levaquin lawsuits have been consolidated in an MDL (mulltidistrict litigation) before Judge John R. Tunheim in the U.S. District Court for the District of Minnesota. On December 8, 2010 Johnson & Johnson was ordered to pay plaintiff John Schedin $1.1 million in punitive damages, as well as compensatory damages in the amount of $700,000, in the first Levaquin MDL case to go to trial. The federal court jury in Minneapolis found that Johnson & Johnson together with its Ortho-McNeil-Janssen Pharmaceuticals unit had failed to properly warn of the risks of taking levaquin. This failure to warn resulted in a combined verdict of $1,800.000.00 for the plaintiff. The Venardi Law Firm is continuing to review and investigate potential lawsuits for users of the antibiotic who have suffered a tendon rupture or fatal rashes associated with Stevens-Johnson Syndrome (SJS).

When to call the Venardi Law Firm: Taking levofloxacin increases the risk that you will develop tendinitis (swelling of a fibrous tissue that connects a bone to a muscle) or have a tendon rupture (tearing of a fibrous tissue that connects a bone to a muscle) during your treatment or for up to several months afterward. These problems may affect tendons in your shoulder, your hand, the back of your ankle, or in other parts of your body. Tendinitis or tendon rupture may happen to people of any age, but the risk is highest in people over 60 years of age. Tell your doctor if you have or have ever had a kidney, heart, or lung transplant; kidney disease; a joint or tendon disorder such as rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function); or if you participate in regular physical activity. Tell your doctor and pharmacist if you are taking oral or injectable steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), or prednisone (Sterapred). If you experience any of the following symptoms of tendinitis, stop taking levofloxacin, rest, and call your doctor immediately: pain, swelling, tenderness, stiffness, or difficulty in moving a muscle. If you experience any of the following symptoms of tendon rupture, stop taking levofloxacin and get emergency medical treatment: hearing or feeling a snap or pop in a tendon area, bruising after an injury to a tendon area, or inability to move or bear weight on an affected area.

There have also been reports of Steven-Johnson Syndrome (SDS) in patients. SDS is a rare but sometimes fatal skin disease in which cell death causes the epidermis to separate from the dermis. Symptoms start with sore throat, fever and fatigue followed by ulcers and other lesions in the mucous membranes of the mouth, genital and anal regions.

Call the Venardi Law Firm if you are experiencing any of the above described adverse side effects of taking Levaquin.