"The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of factor VIII-containing products to evaluate the risk of neutralizing antifactor VIII alloantibodies (inhibitors) developing in patients"...
Agrylin Consumer (continued)
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
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: unusual bleeding/bruising, black stools, swelling of the ankles/feet, rapid/difficult breathing, stomach/abdominal pain, unusual tiredness, change in the amount of urine, pink/bloody urine, vomit that looks like coffee grounds.
Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, confusion/mental changes, severe dizziness, fainting, fast/irregular/pounding heartbeat, seizures, slurred speech, vision changes, weakness on one side of the body.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, 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 Agrylin (anagrelide) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking anagrelide, 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: heart problems (e.g., heart attack, irregular heartbeat), lung problems, kidney problems, liver problems.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Anagrelide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using anagrelide, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using anagrelide safely.
Before having surgery, tell your doctor or dentist that you are using this medication.
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
This medication must not be used during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.
This medication may pass into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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