AUDIENCE: Family Practice, Infectious Disease, Neurology, Pharmacy, Patient
ISSUE: FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, FDA revised the Boxed Warning, FDA's strongest warning, to address these serious safety issues. In addition, FDA updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.
FDA has determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.
FDA is continuing to assess safety issues with fluoroquinolones as part of FDA's usual ongoing review of drugs and will update the public if additional actions are needed. See the FDA Drug Safety Communication, available at: http://bit.ly/2avaEuk, for additional information, including a Data Summary and Additional Information for Health Care Professionals and Patients.
BACKGROUND: The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA's 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone
RECOMMENDATION: Patients must 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 unusual joint or tendon pain, muscle weakness, a "pins and needles" tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones in the FDA Drug Safety Communication, available at: http://bit.ly/2avaEuk).
Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop 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.
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.
Using moxifloxacin injection increases the risk that you will develop tendinitis (swelling of fibrous tissue that connects a bone to a muscle) or have a tendon rupture (tearing of 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 using moxifloxacin injection, 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 using moxifloxacin injection 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 to bear weight on an affected area.
Using moxifloxacin injection 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 use moxifloxacin injection. If you have myasthenia gravis and your doctor tells you that you should use moxifloxacin injection, call your doctor immediately if you experience muscle weakness or difficulty breathing during your treatment.
Talk to your doctor about the risks of using moxifloxacin injection.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with moxifloxacin injection. 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 check the manufacturer's website to obtain the Medication Guide.
Why is this medication prescribed?
Moxifloxacin injection is used to treat certain infections such as pneumonia; bronchitis; and sinus, skin, and abdominal (stomach area) infections caused by bacteria. Moxifloxacin injection is in a class of antibiotics called fluoroquinolones. It works by killing the bacteria that cause infections. Antibiotics will not work against colds, flu, or other viral infections.
How should this medicine be used?
Moxifloxacin injection comes as a solution (liquid) to be given through a needle or catheter placed into a vein. It is usually infused (injected slowly) intravenously (into a vein) over a period of at least 60 minutes once a day for 5 to 21 days. The length of treatment depends on the type of infection being treated. Your doctor will tell you how long to use moxifloxacin injection.
You may receive moxifloxacin injection in a hospital, or you may use the medication at home. If you will be using moxifloxacin injection at home, use it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or other healthcare provider to explain any part you do not understand. Use moxifloxacin injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
If you will be using moxifloxacin injection at home, your health care provider will show you how to infuse the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems infusing moxifloxacin injection.
You should begin to feel better during the first few days of treatment with moxifloxacin injection. If your symptoms do not improve or if they get worse, call your doctor.
Use moxifloxacin injection until you finish the prescription, even if you feel better. Do not stop using moxifloxacin injection without talking to your doctor unless you experience certain serious side effects listed in the IMPORTANT WARNING and SIDE EFFECTS sections. If you stop using moxifloxacin injection too soon or if you skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Other uses for this medicine
Moxifloxacin injection is also sometimes used to treat tuberculosis (TB) and endocarditis (infection of the heart lining and valves) when other medications cannot be used. 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 using moxifloxacin injection,
- tell your doctor and pharmacist if you are allergic to moxifloxacin, other quinolone or fluoroquinolone antibiotics such as ciprofloxacin (Cipro), gatifloxacin (Tequin) (not available in the U.S.), gemifloxacin (Factive), levofloxacin (Levaquin), lomefloxacin (Maxaquin) (not available in the U.S.), nalidixic acid (NegGram), norfloxacin (Noroxin), ofloxacin (Floxin), and sparfloxacin (Zagam) (not available in the U.S.), or any other medications.
- 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); nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Naprosyn, others); cisapride (Propulsid) (not available in the U.S.); diuretics ('water pills') erythromycin (E.E.S., E-Mycin, Erythrocin, others); or certain medications for irregular heartbeat including amiodarone (Cordarone), disopyramide (Norpace), procainamide (Procanbid), quinidine, and sotalol (Betapace, Betapace AF, Sorine). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- 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, cerebral arteriosclerosis (narrowing of blood vessels in or near the brain that can lead to stroke or mini-stroke), seizures, chest pain, a slow heartbeat, a low level of potassium in your blood, or liver disease.
- tell your doctor if you are pregnant or plan to become pregnant or if you are breast-feeding. If you become pregnant while using moxifloxacin injection, call your doctor.
- you should know that moxifloxacin injection may cause dizziness and lightheadedness. Do not drive a car, operate machinery, or participate in activities requiring alertness or coordination until you know how moxifloxacin injection 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. Moxifloxacin injection may make your skin sensitive to sunlight. Call your doctor if you develop skin redness or blisters during your treatment with moxifloxacin injection.
What special dietary instructions should I follow?
Make sure you drink plenty of water or other fluids every day during your treatment with moxifloxacin injection.
What should I do if I forget a dose?
Use 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 use a double dose to make up for a missed one.
What side effects can this medication cause?
Moxifloxacin injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- loss of appetite
- change in ability to taste food
- sores in the mouth or on the tongue
- white patches in the mouth
- dry mouth
- vaginal itching or burning
- irritation, pain, tenderness, redness, warmth, or swelling at the injection spot
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately, but do not stop using moxifloxacin injection 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 are trying to harm you
- thoughts about harming or killing yourself
- hallucinations (seeing things or hearing voices that do not exist)
- difficulty falling asleep or staying asleep
- 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 using moxifloxacin injection 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
Moxifloxacin injection may cause problems with bones, joints, and tissues around joints in children. Moxifloxacin injection should not be given to children younger than 18 years of age.
Moxifloxacin injection may cause nerve damage that may not go away even after you stop using moxifloxacin injection. This damage may occur soon after you begin using moxifloxacin injection. 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 use any more moxifloxacin injection until you talk to your doctor. Your doctor may prescribe a different antibiotic for you to use instead of moxifloxacin injection.
Talk to your doctor about the risks of using moxifloxacin injection or giving moxifloxacin injection to your child.
Moxifloxacin injection may cause other side effects. Call your doctor if you have any unusual problems while you are using 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?
If you will be using moxifloxacin injection at home, your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly.
Keep your supplies in a clean, dry place out of the reach of children when you are not using them. Your healthcare provider will tell you how to throw away used needles, syringes, tubing, and containers to avoid accidental injury.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
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 moxifloxacin injection.
Do not let anyone else use your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish using moxifloxacin injection, 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.
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