"The U.S. Food and Drug Administration announced today that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use."...
Avastin Consumer (continued)
Dry mouth, cough, voice changes, loss of appetite, diarrhea, vomiting, constipation, mouth sores, nausea, headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist immediately.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: trouble breathing, swelling of ankles/feet, sudden weight gain, fast heartbeat, signs of infection (e.g., fever, persistent sore throat), muscle cramps, muscle loss, yellowing eyes/skin, frothy/dark urine, difficulty urinating, decreased amount of urine.
Symptoms of a severe infusion reaction that may occur during bevacizumab treatment include difficulty breathing, flushing, severe dizziness, nausea/vomiting, shaking, or chest pain. Tell your healthcare professional if you have any of these symptoms during your treatment. Your doctor will monitor you closely and will temporarily stop your treatment if a reaction occurs.
Bevacizumab may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you have a history of blood clots, heart/blood vessel disease, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes.
This medication can cause bleeding. Some episodes may be minor including nosebleeds, minor gum bleeding, and vaginal bleeding. If these persist or worsen, notify your doctor or pharmacist promptly. Other episodes may be more serious including stomach bleeding or bleeding in the lungs (see also Warning section).
This medication may cause high blood pressure. This reaction can be severe enough to require blood pressure treatment. Learn to check your blood pressure regularly and share the results with your doctor.
Rarely, bevacizumab may cause a condition called PRES (posterior reversible encephalopathy syndrome). Get medical help right away if you develop persistent headache, seizures, sudden vision changes, mental/mood changes (e.g., confusion).
This medication may affect the ovaries, possibly reducing fertility and causing hormone changes. Talk to your doctor for more details.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, severe trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Avastin (bevacizumab) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Warning and Side Effects sections.
Before using bevacizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal ulcers, bleeding problems (such as recent bloody vomiting or coughing up blood), recent major surgery, recent injuries/wounds, high blood pressure, kidney disease, diabetes.
Before having surgery or any medical procedure, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Bevacizumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Do not have immunizations/vaccinations without your doctor's consent and avoid contact with people who have recently received oral polio vaccine.
Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised, or injured.
Caution is advised when using this drug in the elderly because they may be at greater risk for side effects (e.g., blood clots, kidney effects such as protein in the urine). See also Side Effects section.
This medication should be used only when clearly needed during pregnancy. Bevacizumab may cause harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Women of child-bearing age should use an effective form of birth control while using this medication and for an extended period after stopping this drug. Discuss the risks, benefits and any other concerns with your doctor.
Based on information from related drugs, this medication may pass into breast milk. Therefore, breast-feeding while using this medication is not recommended. Also, do not breast-feed for extended period after stopping this drug. Consult your doctor or pharmacist before breast-feeding and if more details are needed.
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