Voluntary US recall of peginesatide injection due to postmarketing reports of serious hypersensitivity reactions

Source: FDA Area: News The US FDA is informing the public about a voluntary recall of all lots of peginesatide (Omontys®) injection. This action is being taken due to new postmarketing reports of serious hypersensitivity reactions, including anaphylaxis, that have occurred within 30 minutes after administration.   Peginesatide injection is licensed in the US for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis. It is not currently licensed in the EU but a Marketing Authorisation Application is currently under review by the European Medicines Agency (see link below).   The rate of overall hypersensitivity reactions reported in patients receiving peginesatide is approximately 0.2%, with around a third being serious. To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. There have been no reports of such reactions following subsequent dosing, or in patients who have ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news