FDA Approves Ferriprox( FDA new drug approvals)
Ferriprox
Generic Name: Deferiprone
Company: ApoPharma Inc.
Date of Approval: October 14, 2011
Company: ApoPharma Inc.
Date of Approval: October 14, 2011
Treatment for: Transfusional Iron Overload
The U.S. Food and Drug Administration has approved Ferriprox (deferiprone) to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.
Patients with thalassemia have excess iron in the body from the frequent blood transfusions (transfusional iron overload), a condition that is serious and can be fatal. These patients also have a risk of developing liver disease, diabetes, arthritis, heart failure or an abnormal heart rhythm.
The standard of care to treat transfusional iron overload is chelation therapy - chemical agents that are used to remove heavy metals from the body. Ferriprox is intended for use when chelation therapy is inadequate.
What is Ferriprox?
Ferriprox (deferiprone) is an iron-chelating agent. It binds to iron and removes it from the blood stream.
Ferriprox is used to treat iron overload caused by blood transfusions in patients with thalassemia (a generic blood disorder that causes anemia) who have not responded to other chelation treatments.
Ferriprox may also be used for purposes not listed in this medication guide.
Important information about Ferriprox
You should not use Ferriprox if you:
· are allergic to deferiprone or any of the other ingredients in Ferriprox.
· have had a history of episodes of neutropenia (low white clood cell count) or agranulocytosis.
· you are pregnant or breastfeeding.
Before taking Ferriprox, tell your doctor if you have kidney or liver disease, cancer (especially blood cell cancer such as leukemia), or a weak immune system.
Take Ferriprox as directed by your doctor (usually three times daily). Taking Ferriprox with food may reduce any associated nausea symptoms.
Stop taking Ferriprox and call your doctor at once if you experience any symptoms of infection such as fever, sore throat or flu-like symptoms. Seek immediate medical attention if you experience palpitations, dizziness, lightheadedness, syncope or seizures.
If you are taking antacids that contain aluminum (such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others) or supplements that contain iron or zinc, allow at least a four hour interval before or after taking Ferriprox.
Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products.
Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
New Drug Approvals
The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.
November 2011
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Date of Approval: October 14, 2011
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Shamna
Sr lecturer
Alshifa college of pharmacy
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