Eprex Maker to Add Warning to Drug's Label
December 4, 2002
Just days after European health regulators announced they were considering a ban on use of the anemia drug Eprex in patients with chronic kidney failure due to its link to pure red cell aplasia (PRCA), Janssen-Cilag, a European subsidiary of Johnson & Johnson, said it will change the prescribing information of the medication to warn of subcutaneous administration in patients with chronic renal failure symptoms.
Johnson & Johnson has received 160 reports of PRCA among users of Eprex, with nearly all the cases occurring in patients taking the drug via subcutaneous injection. The company has already sent letters to physicians recommending Eprex be administered intravenously. The European Union's drug safety monitors are continuing to discuss the possibility of the ban, which was proposed by French health officials.
-- Article Courtesy of InjuryBoard.com
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