The Hindu Business Line : A drug for anaemic patients — FDA tells J&J group co to modify information label

JANSSEN-CILAG Pharmaceuticals, part of Johnson & Johnson Ltd, has been asked to modify the label on the vial of Eprex (a drug administered on patients due to kidney failure) to clearly state that the drug must be administered through the intravenous route only.

The Maharashtra Food and Drug Administration (FDA) had received complaints regarding the administration of the drug through the subcutaneous route. It was found that if the drug is administered subcutaneous, the risk of developing pure red cell aplasia (PRCA) in patients undergoing dialysis is very high.

PRCA is a rare condition bone marrow disorder, which can also occur as an adverse consequence of certain therapies.

Eprex, contains the active ingredient Epoetinum alfa, a synthetic version of the naturally occurring hormone erythropoietin. The hormone, produced by healthy kidneys, stimulates the bone marrow to produce red blood cells. In several markets, it is available in two forms, with and without human serum albumin (HSA), a plasma protein that aids the body in maintaining blood pressure.

Mr A. Ramakrishnan, Commissioner, Maharashtra FDA told Business Line, "While the inserts in the pack talks about the risks of the product and state that the drug has to be administered intravenously, the label on the syringe does not contain the caution note. We have asked the company to rectify this. The company, on its part, has agreed to modify the pack to clearly state that Eprex must be administered through the IV route for chronic renal failure patients."

When contacted, a J&J spokesperson said, "We have not yet received any written communication from Maharashtra FDA. Earlier the pack inserts contained all the warnings, now the regulator wants it on the vial."

About two-three years ago, the drug was in the spotlight in Europe and some other markets due to the risk of developing PRCA. Subsequently, the company changed the prescribing information for Eprex. In India, about 10 other companies including Ranbaxy, Wockhardt, Roche and Emcure manufacture synthetic versions of erythropoietin.

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