Tamiflu for infants: CDC and FDA tell pharmacists to get it right

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The Food and Drug Administration and the Centers for Disease Control and Prevention called today for pharmacists to be more careful in how they dispense a liquid suspension of the antiviral agent Tamiflu for infants who have contracted the pandemic H1N1 influenza virus. In a letter to the New England Journal of Medicine last week, physicians noted that dosing directions for the drug for infants are generally given in units of teaspoons, whereas the dropper contained in the package is marked in milligrams, making a confusing conversion of units necessary. In a follow-up letter to the journal today, the two agencies noted that the drug was designed for adults and older children, for whom the dropper is marked correctly. Tamiflu is not approved for use in infants, but may be given under an Emergency Use Authorization. When that is done, ‘the syringe in the package should always be replaced with an appropriate measuring device, because doses for children younger than one year of age cannot be measured with the manufacturer’s syringe.’ In other words, it’s the pharmacist’s responsibility to put a different dropper in the box.

-- Thomas H. Maugh II

Confusing directions: The dosing directions on the label don’t match the enclosed syringe.