FDA Warns Sanofi Over Ad For Prostate Drug
27 Octubre 2009 - 11:34AM
Noticias Dow Jones
The U.S. Food and Drug Administration has warned Sanofi-Aventis
SA (SNY) that an advertisement for its drug, Uroxatral, fails to
mention risks associated with the medicine.
The advertisement for Uroxatral, used to treat enlarged
prostates, was a "tent card" and was presented with an outdated
version of the drug's label, according to a letter the FDA sent to
Sanofi on Friday. The letter was posted on the FDA's Web site
Tuesday. Tent cards are folded and placed atop tables to display
information on two sides.
The FDA approved Uroxatral in 2003 to treat patients with
enlarged prostates. The label for the medicine has been revised
seven times.
The tent card said "ALWAYS IN THE BATHROOM...especially at
night?" and "Relief begins with U." The FDA said this statement
misleadingly suggests Uroxatral can be used to treat anything that
keeps a person in the bathroom, such as an overactive bladder.
The FDA said the back of the card did include risk information.
The FDA said omitting risk information from the front of the card
can't be corrected "merely by including the statement 'Please see
Important Safety Information on back."
The FDA wants Sanofi to stop dissemination of the ad and to
respond to the agency by Nov. 6.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com