FDA Cites Pfizer Zyrtec-D Promotions For Omission Of Risk Information
This article was originally published in The Pink Sheet Daily
Executive Summary
A professional sales aid and the product website fail to include contraindications and warnings for the drug’s decongestant component pseudoephedrine, an FDA ad division letter states.
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Promotional materials for Pfizer's Zyrtec-D fail to discuss risks of the drug's decongestant component, an April 22 1 FDA ad division letter says. A professional sales aid and the product website, 2 www.zyrtec.com, do not include contraindications and warnings regarding Zyrtec-D's pseudoephedrine component. Zyrtec-D contains both Zyrtec's antihistamine ingredient cetirizine and the decongestant pseudoephedrine. The omission of risk information for pseudoephedrine "is a public health concern because Zyrtec-D is contraindicated for several patient populations, and the ingestion of pseudoephedrine may cause serious adverse health consequences," FDA's letter states. Because of the pseudoephedrine component, Zyrtec-D is contraindicated in patients with severe hypertension, coronary artery disease, narrow-angle glaucoma or urinary retention, and those receiving monoamine oxidase inhibitor therapy. FDA Associate Commissioner Peter Pitts recently pointed to Pfizer's website as a model for internet promotion (3 (Also see "Decline In Ad Letters Does Not Signal Leniency By FDA, Agency Says" - Pink Sheet, 31 Mar, 2004.)). - Elizabeth Walker |