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Procrit

"The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfiel"...

Procrit

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Procrit Consumer (continued)

SIDE EFFECTS: Headache, body aches, diarrhea, and irritation at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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.

Epoetin alfa may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. This effect may be caused by the number of red blood cells increasing too quickly, usually within the first 3 months of starting treatment. If you have high blood pressure, it should be adequately controlled before beginning treatment with this medication. Your blood pressure should be checked frequently. Ask your doctor if you should learn how to monitor your own blood pressure. If high blood pressure develops or worsens, follow your doctor's instructions about diet changes and starting or adjusting your high blood pressure medication. Lowering high blood pressure helps prevent strokes, heart attacks, and further kidney problems. Keep all laboratory appointments to have your blood count (hemoglobin) tested regularly to reduce the chance of this side effect.

Get medical help right away if you have any very serious side effects, including: seizures.

This medication may rarely cause blood clots. Get medical help right away if you notice any of the following rare but very serious side effects: pain/redness/swelling/weakness of the arms or legs, calf pain/swelling that is warm to the touch, new/worsening shortness of breath, coughing up blood, sudden vision changes, slurred speech, confusion, weakness on one side of the body, sudden severe headache, chest/jaw/left arm pain, fainting, blood clots in your hemodialysis vascular access site.

Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies that reduce the effectiveness of epoetin alfa, and a very serious anemia can result. Tell your doctor immediately if symptoms of anemia return (e.g., increased tiredness, low energy, pale skin color, shortness of breath).

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, 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 Procrit (epoetin alfa) Side Effects Center for a complete guide to possible side effects

PRECAUTIONS: Before using epoetin alfa, tell your doctor or pharmacist if you are allergic to it; or to other drugs that cause more red blood cells to be made (e.g., darbepoetin alfa); or to products containing human albumin; 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: high blood pressure, blood disorders (e.g., sickle cell anemia, white blood cell or platelet problems, bone marrow problems), bleeding/clotting problems, blood vessel problems (e.g., stroke), heart problems (e.g., angina, heart failure), seizure disorder, a certain metabolic disorder (porphyria), certain vitamin deficiencies (folic acid, vitamin B12).

Infrequently, patients with long-term kidney failure on dialysis may be at increased risk of seizures during the first 3 months of treatment with this medication, possibly caused by the number of red blood cells increasing too quickly. Therefore, these patients should use caution and avoid activities such as driving or using machinery during this period. Limit alcoholic beverages because alcohol may also increase the risk of seizures.

Some forms of this medication are made from human blood. Even though the blood is carefully tested and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, virus infections such as hepatitis). Consult your doctor or pharmacist for more information.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. In some women of child-bearing age, menstrual periods have resumed with epoetin alfa treatment. Therefore, it may be possible to become pregnant while using this medication. Discuss the need for birth control with your doctor.

It is not known whether 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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