FDA Drug Safety Communication: FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol)
The U.S. Food and Drug Administration (FDA) is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). We have changed the prescribing instructions and approved a Boxed Warning, FDA’s strongest type of warning, regarding these serious risks. Also added is a new Contraindication, a strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product. Health care professionals should follow the new recommendations in the drug label. Patients should immediately alert their health care professional or seek emergency care if they develop breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash, or itching during or after Feraheme administration.
Feraheme is in a class of medicines called IV iron replacement products. It is used to treat iron-deficiency anemia―a condition in which there is a lower than normal number of oxygen-carrying red blood cells because of too little iron. People with anemia may feel tired or weak, and if left untreated, anemia can damage the heart, brain, and other organs. Feraheme is specifically approved for use only in adults with iron deficiency anemia in patients with chronic kidney disease. It is given as an IV infusion by health care professionals in a hospital, outpatient clinic, or medical office. Like other IV iron products, Feraheme may only be given where emergency personnel and equipment are immediately available to treat the potentially life-threatening allergic reactions that can occur with treatment.
All IV iron products carry a risk of potentially life-threatening allergic reactions. At the time of Feraheme’s approval in 2009, this risk was described in the Warnings and Precautions section of the drug label. Since then, serious reactions, including deaths, have occurred despite the proper use of therapies to treat these reactions and emergency resuscitation measures (see Data Summary). We have evaluated this risk further and have identified ways to reduce the risk of serious allergic reactions with Feraheme.
Based on our evaluation, the prescribing instructions and other label information were updated, adding aBoxed Warning that describes these serious risks and recommending that health care professionals:
- Only administer IV iron products to patients who require IV iron therapy.
- Do not administer Feraheme to patients with a history of allergic reaction to Feraheme or other IV iron products.
- Only administer diluted Feraheme as an IV infusion over a minimum of 15 minutes. Feraheme should not be given as an undiluted IV injection.
- Closely monitor patients for signs and symptoms of serious allergic reactions, including monitoring blood pressure and pulse during Feraheme administration and for at least 30 minutes following each infusion.
- Carefully consider the potential risks and benefits of Feraheme administration in elderly patients with multiple or serious medical conditions, as these patients may experience more severe reactions.
- Carefully consider the potential risks and benefits of Feraheme administration in patients with a history of multiple drug allergies. Patients with multiple drug allergies may also be at higher risk.
Source : FDA (March 2015)
Fatal Reactions Prompt Omontys Recall
All lots of the new anemia drug peginesatide (Omontys) have been recalled because of severe hypersensitivity reactions -- some fatal -- observed after the drug was approved last March.
"No new or existing patients should receive Omontys," according to a statement from the two firms selling the drug, Affymax and Takeda. However, they stopped short of saying the product was being withdrawn from the market.
According to the companies and the FDA, fatal anaphylactic reactions have occurred in 0.02% of patients taking the drug. The absolute number of deaths was not stated. More than 25,000 people have received the drug since it was approved, the FDA said.
"The rate of overall severe hypersensitivity reactions reported is approximately 0.2%, with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization," Affymax and Takeda said in the statement, which was included in the FDA's recall notice.
Peginesatide, a synthetic erythropoiesis stimulating agent, was approved to treat adult patients on hemodialysis with anemia stemming from chronic kidney disease. It is given by injection and packaged in 10- and 20-mg multidose vials.
The FDA recommended that dialysis clinics stop using the product immediately. Takeda and Affymax said they were notifying healthcare professionals and customers of the recall, with instructions on how to return the product.
The drug was approved by the FDA in March 2012 after an advisory panel had endorsed the drug by a 15-1 vote, with one member abstaining.
During that meeting, panel chair Wyndham Wilson, MD, PhD, chief of the lymphoma division at the National Cancer Institute in Bethesda, Md., said it appeared that peginesatide "doesn't have any safety signals."
Some 2,600 patients had participated in the drug's phase III trials, about half of them assigned to peginesatide.
Source : MedPage Today
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