Feraheme Recall Issued In Switzerland After Hypersensitivity Deaths

A batch of anemia, drugs known as Ferahame, have been recalled in Switzerland following the death of at least one patient and several reports involving hypersensitivity reactions.  

Known in Switzerland as Rienso, makers Amag Pharmaceuticals and Takeda Pharmaceuticals issued a Feraheme recall earlier this week. The recall is limited to Switzerland, but the same medication is sold in the U.S. and other countries as well.

The recall came after reports of hypersensitivity reactions with Feraheme in Switzerland, which the makers believe may be tied to a specific batch sold there. They are investigating the batch and adverse event reports from Switzerland and other countries to see if the problem is more widespread.

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Four Swiss patients suffered hypersensitivity reactions after taking the drug and one died. All appear to be linked to the same batch. New batches of the drug will not be sent to the Swiss without approval from that government.

Feraheme (ferumoxyo) is approved to treat anemia in patients with chronic kidney disease. It belongs to a class of drugs known as parental iron replacement drugs. The drug carries warnings of possible hypersensitivity and anaphylactic reactions that could be fatal.

Other anemia treatments, such as the erythropoiesis-stimulating agents (ESAs) Aranesp, Epogen and Procrit have also come under fire in recent years amid concerns about potential health risks.

Aranesp (darbepoetin alfa), Epogen (Epoetin alfa) and Procrit (Epoetin alfa) are ESAs prescribed to patients with kidney disease, anemia, HIV and cancer to stimulate bones to increase the production of red blood cells. They are also prescribed to patients preparing to undergo major non-heart surgery to reduce the number of transfusions such patients must receive. Amgen manufactures all three drugs, though Procrit is sold and marketed by Johnson and Johnson.

The FDA issued a public health advisory regarding the drugs in 2007, saying that the Anemia drugs could increase the risk of injury or death at high doses. The FDA required the black box warning to alerting patients to the cardiovascular health risks. The black box warning is the strongest label warning the FDA can require of a medication.

The drugs are already restricted under an FDA-required risk evaluation and mitigation strategy (REMS). Doctors and hospitals that wish to prescribe the drugs will now have to undergo special training to identify high risk users and negative side effects.

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