(oh floks' a sin)
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.
BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain serious 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.
Most fluoroquinolone antibiotic drug labels include a warning that blood sugar disturbances, including high blood sugar and low blood sugar and depending on the fluoroquinolone antibiotic class, a range of mental health side effects are already described under Central Nervous System Effects in the Warnings and Precautions section of the drug label, which differed by individual drug.
RECOMMENDATION: The new label changes will add that low blood sugar levels, also called hypoglycemia, can lead to coma and the new label will also make the mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class. The mental health side effects to be added to or updated across all the fluoroquinolones are:
- disturbances in attention
- memory impairment
- serious disturbances in mental abilities called delirium.
FDA continues to monitor and evaluate the safety and effectiveness of medicines after we approve them and they go on the market. In the case of fluoroquinolones, we reviewed reports of cases submitted to FDA and the published medical literature of apparently healthy patients who experienced serious changes in mood, behavior, and blood sugar levels while being treated with systemic fluoroquinolones.
Patients should tell your health care professionals if you are taking a diabetes medicine when your health care professional is considering prescribing an antibiotic, and also if you have low blood sugar or symptoms of it while taking a fluoroquinolone. For patients with diabetes, your health care professional may ask you to check your blood sugar more often while taking a fluoroquinolone. Early signs and symptoms of low blood sugar include:
- pounding heart or very fast pulse
- pale skin
- feeling shaky
- unusual hunger
- unusual anxiety
Health care professionals should be aware of the potential risk of hypoglycemia sometimes resulting in coma, occurring more frequently in the elderly and those with diabetes taking an oral hypoglycemic medicine or insulin.
- Alert patients of the symptoms of hypoglycemia and carefully monitor blood glucose levels in these patients, and discuss with them how to treat themselves if they have symptoms of hypoglycemia.
- Inform patients about the risk of psychiatric adverse reactions that can occur after just one dose.
- Stop fluoroquinolone treatment immediately if a patient reports any central nervous system side effects, including psychiatric adverse reactions, or blood glucose disturbances and switch to a non-fluoroquinolone antibiotic if possible.
- Stop fluoroquinolone treatment immediately if a patient reports serious side effects involving the tendons, muscles, joints, or nerves, and switch to a non-fluoroquinolone antibiotic to complete the patient's treatment course.
Health care professionals should not prescribe fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risks outweigh the benefits in these patients.
Taking ofloxacin 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 ofloxacin, 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 ofloxacin 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 ofloxacin may cause changes in sensation and nerve damage that may not go away even after you stop taking ofloxacin. This damage may occur soon after you begin taking ofloxacin. 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 taking gemifloxacin 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.
Taking ofloxacin may affect your brain or nervous system and cause serious side effects. This can occur after the first dose of ofloxacin. 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 taking ofloxacin 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, or confused, or other changes in your mood or behavior.
Taking ofloxacin 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 ofloxacin. If you have myasthenia gravis and your doctor tells you that you should take ofloxacin, call your doctor immediately if you experience muscle weakness or difficulty breathing during your treatment.
Talk to your doctor about the risks of taking ofloxacin.