AUDIENCE: Health Professional, Infectious Disease, Cardiology, Patient
ISSUE: FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.
BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. Without treatment, some infections can spread and lead to serious health problems (see List of Currently Available FDA-Approved Systemic Fluoroquinolones, available at http://bit.ly/2LN7Omq).
Healthcare professionals should:
- Avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients.
- Prescribe fluoroquinolones to these patients only when no other treatment options are available.
- Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm.
- Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.
- Seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back.
- Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately.
- Inform your health professional before starting an antibiotic prescription, if you have a history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome.
- Not stop the antibiotic without first talking to your health care professional.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Using delafloxacin injection 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, methylprednisolone (Medrol), or prednisone (Rayos). If you experience any of the following symptoms of tendinitis, stop using delafloxacin 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 taking delafloxacin 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.
Using delafloxacin injection may cause changes in sensation and nerve damage that may not go away even after you stop using delafloxacin injection. This damage may occur soon after you begin using delafloxacin injection. Tell your doctor if you have ever had peripheral neuropathy (a type of nerve damage that causes tingling, numbness, and pain in the hands and feet). If you experience any of the following symptoms, stop using delafloxacin injection and call your doctor immediately: numbness, tingling, pain, burning, or weakness in the arms or legs; or a change in your ability to feel light touch, vibrations, pain, heat, or cold.
Using delafloxacin injection may affect your brain or nervous system and cause serious side effects. This can occur after the first dose of delafloxacin injection. Tell your doctor if you have or have ever had seizures, epilepsy, cerebral arteriosclerosis (narrowing of blood vessels in or near the brain that can lead to stroke or ministroke), stroke, changed brain structure, or kidney disease. If you experience any of the following symptoms, stop using delafloxacin injection and call your doctor immediately: seizures; tremors; dizziness; lightheadedness; headaches that won't go away (with or without blurred vision); difficulty falling asleep or staying asleep; nightmares; not trusting others or feeling that others want to hurt you; hallucinations (seeing things or hearing voices that do not exist); thoughts or actions towards hurting or killing yourself; feeling restless, anxious, nervous, depressed, memory problems; or confused, or other changes in your mood or behavior.
Using delafloxacin 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 delafloxacin injection. If you have myasthenia gravis and your doctor tells you that you should use delafloxacin 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 delafloxacin injection.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with delafloxacin. 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?
Delafloxacin injection is used treat skin infections caused by bacteria in adults. Delafloxacin is in a class of antibiotics called fluoroquinolones. It works by killing the bacteria that cause infections.
How should this medicine be used?
Delafloxacin injection comes as a powder to mixed with liquid and given through a needle or catheter placed into a vein. It is usually infused (injected slowly) intravenously (into a vein) over a period of 60 minutes once every 12 hours.
You may receive delafloxacin injection in a hospital, or you may use the medication at home. If you will be using delafloxacin injection at home, your healthcare 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 delafloxacin injection.
You should begin to feel better during the first few days of treatment with delafloxacin injection. If your symptoms do not improve or get worse, call your doctor.
Use delafloxacin injection until you finish the prescription, even if you feel better. Do not stop using delafloxacin injection without talking to your doctor unless you experience certain serious side effects listed in the IMPORTANT WARNING or SIDE EFFECTS sections. If you stop using delafloxacin 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
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using delafloxacin injection,
- tell your doctor and pharmacist if you are allergic or have had a severe reaction to delafloxacin, any other quinolone or fluoroquinolone antibiotic such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin;, any other medications, or any of the ingredients in delafloxacin injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what 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 insulin or other medications to treat diabetes such as chlorpropamide, glimepiride (Amaryl, in Duetact), glipizide (Glucotrol), glyburide (DiaBeta), tolazamide, and tolbutamide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had diabetes or problems with low blood sugar.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using delafloxacin injection, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What side effects can this medication cause?
Delafloxacin injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- irritation, pain, tenderness, redness, warmth, or swelling at the injection spot
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop using delafloxacin injection and call your doctor immediately or get emergency medical treatment:
- 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)
- rash, itching, hives, shortness of breath, tingling or swelling of the face or throat, fainting
- extreme thirst or hunger; pale skin; feeling shaky or trembling; fast or fluttering heartbeat; sweating; frequent urination; trembling; blurred vision; or unusual anxiety
Delafloxacin injection may cause other side effects. Call your doctor if you have any unusual problems while 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).
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call 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 delafloxacin injection. If you have diabetes, your doctor may ask you to check your blood sugar more often while using delafloxacin.
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.