AstraZeneca Unit Is Ordered by the FDA To Stop Running Misleading Advertising

CHRIS ADAMS / Wall Street Journal 16jan02

WASHINGTON -- The Food and Drug Administration told a U.S. unit of AstraZeneca PLC that advertising for its breast-cancer drug Nolvadex was "misleading" and "minimized the risks" of using the medication. The FDA told AstraZeneca to immediately stop running the ad.

In a letter dated Dec. 14, 2001, and recently posted on the FDA's Web site, the federal agency said that a September 2001 magazine advertisement promoted Nolvadex for use after a woman already had been through surgery or radiation therapy. In doing so, however, the FDA said the advertisement was misleading because it implied the drug was more effective "than demonstrated by substantial evidence."

In addition, the FDA said that the ad was misleading because it minimized the occurrence of common side effects. For example, the Nolvadex ad said that in general, most side effects "were hormonal in nature: hot flashes, vaginal discharge, and irregular periods. Most were considered relatively mild." The FDA, however, pointed out that those three side effects "occurred in much higher incidences in patients receiving Nolvadex as compared to those receiving placebo."

"Zeneca undermines the significance of these adverse events in its advertisement," the FDA wrote.

Finally, the FDA cited the company for not properly submitting a copy of its advertisement to the agency when it was released to the public, as required.

The letter was sent by the FDA's Division of Drug Marketing, Advertising, and Communications, which monitors prescription drug advertising in the U.S.

A U.S. official with London-based AstraZeneca couldn't immediately be reached for comment. The FDA typically gets strong compliance from companies cited in such advertising letters, and most companies quickly remove any offending ads.