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FDA Objects to Zyrtec Ads

April 19, 2005
The Food and Drug Administration's crackdown on direct-to-consumer advertising is giving the drug industry a two-Excedrin headache. Earlier this week, Levitra was in the agency's sights, now it's Pfizer's allergy medication Zyrtec.

Drug Ads • Consumers Union Weighs In On Drug Ads • FDA Panel Wants Closer Scrutiny of Drug Ads • AMA Calls For Tighter Drug Ad Oversight • Prescription Drug Ads Influence Patients, Poll Finds • AIDS Foundation Sues Pfizer Over Viagra Ads • AMA Wants Moratorium on Consumer Ads for New Prescription Drugs • Med School Profs Cauterize Drug Ads • Consumer Group Challenges AMA on Drug Ads • AMA Takes No Position On Direct-To-Consumer Drug Ads • Consumer Drug Ads May Influence Doctors' Rx Decisions • FDA Objects to Zyrtec Ads • FDA Panel Gives Vioxx a Yellow Light • Devilish Viagra Ads Pulled • Consumers Sue AstraZeneca Over Nexium Ad Campaign

Pfizer has until April 27 to respond to a warning letter, sent directly to CEO Hank McKinnell, about Zyrtec. The FDA's drug-marketing division reviewed three print ads for the allergy medication and said each one makes unsubstantiated claims about the drug's superiority.

The agency said the print ads make superiority claims about Zyrtec, suggesting it is clinically superior to similar medications.

"To our knowledge, these claims have not been demonstrated by substantial evidence or substantial clinical experience," the FDA's letter stated.

As it did with Levitra, the FDA asked that Pfizer stop advertising Zyrtec pending its response to the warning letter. Pfizer said it would give "careful consideration" to the FDA's comments.

Two of the disputed print ads are headlined: "Tired of your allergy medicine not working?" The third says: "Maybe it's time to switch allergy medicines."

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