AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient
ISSUE: FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.
An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.
As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.
See the FDA Drug Safety Communication (see http://1.usa.gov/1TdvrCk) for a list of currently available FDA approved fluoroquinolones for systemic use.
BACKGROUND: The safety issues described in the Drug Safety Communication were also discussed at an FDA Advisory Committee (see http://1.usa.gov/1TaaUBN) meeting in November 2015.
RECOMMENDATION: Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. 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. Patients should talk with your health care professional if you have any questions or concerns.
Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient's treatment course.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
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.
Taking levofloxacin may worsen muscle weakness in people with myasthenia gravis (a disorder of the nervous system that causes muscle weakness) and cause severe difficulty breathing or death. Tell your doctor if you have myasthenia gravis. Your doctor may tell you not to take levofloxacin. If you have myasthenia gravis and your doctor tells you that you should take levofloxacin, call your doctor immediately if you experience muscle weakness or difficulty breathing during your treatment.
Talk to your doctor about the risks of taking levofloxacin.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with levofloxacin. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.
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.
How should this medicine be used?
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 without talking to your doctor unless you experience certain serious side effects listed in the IMPORTANT WARNING or SIDE EFFECTS sections. 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.
Other uses for this medicine
Levofloxacin is also sometimes used to treat endocarditis (infection of the heart lining and valves), certain sexually transmitted diseases, and tuberculosis (TB). Levofloxacin is also sometimes used to prevent or treat traveler's diarrhea and plague (a serious infection that may be spread on purpose as part of a bioterror attack). Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking levofloxacin,
- 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 U.S.), gemifloxacin (Factive), lomefloxacin (Maxaquin) (not available in the U.S.), moxifloxacin (Avelox), nalidixic acid (NegGram), norfloxacin (Noroxin), ofloxacin (Floxin), and sparfloxacin (Zagam) (not available in the U.S.): 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.
What special dietary instructions should I follow?
Make sure you drink plenty of water or other fluids every day while you are taking levofloxacin.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Levofloxacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- vaginal itching and/or discharge
Some side effects can be serious. If you experience any of these symptoms call your doctor immediately, but do not stop taking levofloxacin without talking to your doctor:
- severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
- not trusting others or feeling that others want to hurt you
- difficulty falling asleep or staying asleep
- nightmares or abnormal dreams
- hallucinations (seeing things or hearing voices that do not exist)
- thoughts about dying or killing yourself
- uncontrollable shaking of a part of the body
If you experience any of the following symptoms, or the symptoms of tendinitis or tendon rupture described in the IMPORTANT WARNING section, stop taking levofloxacin and call your doctor immediately or get emergency medical help:
- peeling or blistering of the skin
- swelling of the eyes, face, mouth. lips, tongue, throat, hands, feet, ankles or lower legs
- difficulty breathing or swallowing
- fast heartbeat
- loss of consciousness
- yellowing of the skin or eyes
- dark urine
- decreased urination
- unusual bruising or bleeding
- joint or muscle pain
Levofloxacin may cause problems with bones, joints, and tissues around joints in children. Levofloxacin should not normally be given to children younger than 18 years of age unless they have been exposed to anthrax in the air. If your doctor prescribes levofloxacin for your child, be sure to tell the doctor if your child has or has ever had joint-related problems. Call your doctor if your child develops joint problems, such as pain or swelling, while taking levofloxacin or after treatment with levofloxacin.
Levofloxacin may cause nerve damage that may not go away even after you stop taking levofloxacin. This damage may occur soon after you begin taking levofloxacin. If you experience any of the following symptoms, call your doctor immediately: numbness, tingling, pain, or burning in the arms or legs; or a change in your ability to feel light touch, pain, heat, or cold. If you experience these symptoms, do not take any more levofloxacin until you talk to your doctor. Your doctor may prescribe a different antibiotic for you to take instead of levofloxacin.
Talk to your doctor about the risks of taking levofloxacin or giving levofloxacin to your child.
Levofloxacin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to levofloxacin.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking levofloxacin.
Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish taking levofloxacin, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.