SFDA warns against IV administration of iron

The Saudi Food and Drug Authority (SFDA) has warned people against the possible risks of hypersensitivity reactions after intravenous (IV) administration of iron products.

In order to minimize such risks, the SFDA has recommended IV iron products be administered in accordance with the posology and method of administration described in the individual product information.

According to the SFDA, IV iron products should not be used in patients with hypersensitivity to the active substance, the product itself, or any of its exceptions; and in patients with serious hypersensitivity to other parenteral iron products.

Patients should be closely monitored for signs of hypersensitivity for at least 30 minutes after the administration of each IV iron product.

The risk of hypersensitivity is increased in patients with known allergies (including drug allergies) and in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis) as well as in patients with a history of severe asthma, eczema or other atopic allergy. In these patients, IV iron products should only be used if the benefit is clearly judged to outweigh the potential risk.

IV iron products should only be administered when staff trained to evaluate and manage anaphylactic/anaphylactoid reactions as well as resuscitation facilities are immediately available.

Patients should be informed of the risk of hypersensitivity before each administration and mindful of the relevant symptoms to seek urgent medical attention if a reaction occurs.

IV iron products should not be used during pregnancy unless clearly necessary. Treatment should be confined to second or third trimester, if the benefit is clearly judged to outweigh the potential risks for both the mother and the fetus. The risks to the fetus can be serious and include fetal anoxia and distress.

The test dose may lead to false reassurance as allergic reactions may occur even in patients that had a negative test dose.


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