"The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug ferumoxytol (Ferumoxytol, AMAG Pharmaceuticals), stating that even with current warnings, there have been 79 anaphylactic r"...
Feraheme Consumer (continued)
Dizziness or fainting (hypotension) may occur. Pain, swelling, or redness at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness or fainting, 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 any of these unlikely but serious side effects occur: unusual bruising, skin darkens (bronze tone), swelling of hands/feet/lower legs, chest pain.
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 Feraheme (ferumoxytol injection) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking ferumoxytol, tell your doctor or pharmacist if you are allergic to it; or if you have had a reaction to other types of injectable iron; 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.
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 use and for 3 months after your last injection, tell X-ray staff that you use or used this medication. This medication can interfere with the results of an MRI scan.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults that have a serious allergic reaction or dizziness while using this drug may have more severe symptoms.
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.
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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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