FDA Warns AstraZeneca Over Ads

U.S. FDA warns AstraZeneca over breast-cancer ads

NEW YORK, Jan 16 (Reuters)

United States regulators have told AstraZeneca that the Anglo-Swedish drug maker has to stop running what it called ``misleading'' ads for breast-cancer drug Nolvadex.

The letter, posted on the U.S. Food and Drug Administration's (FDA) website, said that AstraZeneca Pharmaceuticals had ``minimized the risks associated with (Nolvadex's) use'' in an ``InTouch'' magazine advertisement.

The letter, highlighted by The Wall Street Journal on Wednesday, said the September ad was misleading because it implied that Nolvadex was more effective ``than demonstrated by substantial evidence.'' The ad downplayed common side effects and did not provide enough context, the FDA said.

The advertisement said that side-effects ``were hormonal in nature: hot flashes, vaginal discharge and irregular periods. Most were considered relatively mild,'' according to the Wall Street Journal's online edition.

Company spokesman Staffan Ternby said he had not heard of this specific warning from the FDA but said AstraZeneca in general always does what the FDA tells them to -- he was quite sure they would pull the ad if they had not done so already.

[01/16/2002; Reuters News Service]

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