Takeda UK Ltd has issued a recall on its 'Rienso’ product as FDA issues its strongest warning possible
The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anaemia drug ferumoxytol (branded Rienso in the UK and Europe and Feraheme in the United States) reporting that, even with its current warnings in place, there have been 18 deaths associated with allergic or hypersensitivity reactions in the United States alone.
Rienso, and other drugs approved to treat anaemia in patients with chronic kidney disease, belong to a class of drugs known as parental iron replacement drugs. Since 2007, such drugs have carried warning of possible hypersensitivity and anaphylactic reactions that could be fatal. The FDA has now issued its strongest warning possible known as a ‘boxed warning’ that signifies that the drug carries a significant risk of serious or even life-threatening adverse effects. In January 2015, European Regulators reported that there they were aware of 264 serious cases of hypersensitivity reactions associated with Rienso culminating in 35 deaths worldwide.
The UK supplier, Takeda UK, recently wrote to healthcare professionals to advise they were withdrawing the medicine from the market for ‘commercial reasons.’
This is not the first time the drug has been the focus of scrutiny. In 2013, a batch of the medicine was recalled in Switzerland after four patients suffered hypersensitivity reactions resulting in 1 death.
Brian McFerran, a Product Liability Lawyer at Leigh Day, commented: “It appears that the manufacturer of this product has been aware of the risk of potentially fatal allergic reactions for a number of years. The manufacturer must now clarify the commercial reasons that now mean this product needs to be withdrawn.
"Patients have every right to expect medicines that are prescribed to be safe and for manufacturers to act quickly to recall products when safety issues arise."