Janssen finds itself in hot water over Xarelto ad

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Therapeutic Focus 2013: Cardiovascular
Therapeutic Focus 2013: Cardiovascular

FDA advertising watchdogs have taken issue with a Janssen advertisement promtoting the blood thinner Xarelto. The agency's Office of Prescription Drug Promotion issued a June 6 untitled letter to outline the reasons for its displeasure with an ad that the drug maker ran in the January/February issue of WebMD Magazine.

The bad-ad team says the ad's use of bold-face type and colorful text is employed in such a way that it effectively minimizes the drug's risks, particularly because the facing page outlining the risk lacks the colorful text and boldfaced styling, making the two pages appear “unconnected to the efficacy claims.”

The letter also noted that the overall presentation of the ad “misleadingly minimizes the risks associated with Xarelto because it fails to convey this important risk information with a prominence and readability reasonably comparable to the efficacy claims.”

The advertisement does boldface the phrase, “Please see accompanying Medication Guide on the following pages,” but OPDP says this is not sufficient.

OPDP said the ad also makes a misleading claim, asserting that “there are no dosage adjustments...” This conflicts with the PI's statement that dosage should be lowered for certain patients, OPDP wrote.

Online, Xarelto was the most widely advertised brand in 2012, according to Kantar Health. The drug is approved for deep vein thrombosis and pulmonary embolism. The FDA has twice rejected an application to expand the approved uses of the drug to include stroke and heart attack reduction among patients with acute coronary syndrome.

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