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
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
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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