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Be aware – new labelling of Novo-Ferrogluc

February 24, 2009

Thanks to Pam Nickel of Rexall Outpatient Pharmacy at the U of A Hospital, who notified us that the labelling of Novo-Ferrogluc has recently changed. Please note that each tablet contains 35 mg elemental iron, NOT 35 mg of ferrous gluconate. Pam states, “I believe this is a patient safety issue and could result in overdose if patients think they should take 8.5 tablets in order to get the right dose (35mg x 8.5 = 300mg).”

Novopharm has advised Pam and ACP that, “We are aware of the safety concern that the new label has created and we are currently in the process of correcting the writing on the label and clarifying the strength of the ferrous gluconate. The corrected label will indicate, ‘Novo-Ferrogluc, Ferrous Gluconate Tablets USP 300 mg (equivalent to 35 mg elemental iron)’. The product with the corrected label will soon be on the market.”

Ferrous gluconate 300 mg (35 mg of elemental iron) is a Schedule 2 product. While Standard 7 of the Standards for Pharmacist Practice only requires you to enter into a dialogue with a patient who is purchasing a Schedule 2 drug for the first time, your dialogue with patients seeking this product, regardless of their purchasing history, is an opportunity to clarify the labelling and the correct dosing of this product.

Originally published in the February 24, 2009, issue of The Link