"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"...
Amicar Consumer (continued)
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 immediately if any of these unlikely but serious side effects occur: ringing in the ears, vision changes, shortness of breath.
Tell your doctor immediately if any of these rare but very serious side effects occur: muscle pain/weakness, change in the amount of urine, confusion, slow heartbeat, persistent sore throat, unusual bleeding or bruising.
Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 Amicar (aminocaproic acid) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking aminocaproic acid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as paraben preservatives in the liquid product), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: bleeding of unknown cause, a certain bleeding condition (disseminated intravascular coagulation-DIC), a certain clotting problem (active intravascular clotting), a certain cause of blood in the urine (upper urinary tract bleeding).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, liver disease, kidney disease, other blood/bleeding disorders (e.g., hemophilia, uremia).
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.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Additional Amicar Information
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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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