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To: Anthony Wong who wrote (501)7/9/1998 6:21:00 PM
From: Anthony Wong  Read Replies (1) | Respond to of 1722
 
Pfizer Canada Distributes Letter To Canadian Physicians Regarding Viagra-Nitrates Contraindication

July 09, 1998 6:13 PM

Mailing is in response to growing use by Canadians
of drug for erectile dysfunction not yet approved in Canada

KIRKLAND, Que., July 9 /CNW/ - Pfizer Canada Inc.
has sent a letter to 55,000 physicians in Canada giving
them information related to the interaction of nitrates
with VIAGRA (sildenafil citrate), the Pfizer drug for
erectile dysfunction which is undergoing regulatory
review in Canada.

Since the drug's approval by American authorities on
March 27, it has been reported that Canadians have
been purchasing VIAGRA in the U.S., or via the
Internet, with prescriptions written by Canadian or
American physicians. Pfizer Canada does not condone
the use of VIAGRA by Canadians before it is approved
in Canada. Until such time, the company is prohibited by
federal government regulations from
promoting/marketing the drug, including its normal
activities of informing doctors about the full profile of the
drug, including its indications, contraindications and full
prescribing information. In this case, however, with the
knowledge of Health Canada, Pfizer Canada has sent
selected information on VIAGRA in response to the
significant usage of the drug in Canada resulting in large
part from the media attention VIAGRA has received.

''We cannot change the fact that many Canadians have
purchased VIAGRA in the U.S., so the responsible
action for us, which we are taking with this letter, is to
provide important information related to this
contraindication to Canadian physicians,'' said Dr. Pierre
B. Roland, M.D., Vice-President and Medical Director
of Pfizer Canada Inc., who signed the letter.

By publicizing the sending of the letter via the media, Dr.
Roland added, the company hopes to draw physicians'
attention to the presence of the letter which they should
receive by mail after it was sent during the week of July
6.

The letter is intended to draw the attention of doctors to
a contraindication that has long been known. That is that
VIAGRA cannot be taken with any drug from a class
called organic nitrates. These drugs, which include
nitroglycerin, are commonly taken by people to
counteract the chest pain of angina. Due to a known
physiological mechanism which is explained in the letter,
nitrates in combination with VIAGRA can cause blood
pressure to fall abruptly, which may lead to serious
medical complications, in particular in persons with
underlying heart disease.

''Although the nitrates contraindication is very important
for those it may affect, this applies only to a sub-group
of the some 3 million Canadian men suffering from
erectile dysfunction,'' said Dr. Gerald Brock, Associate
Professor, Department of Urology at The University of
Western Ontario in London, Ontario. ''I am very
pleased that Pfizer and Health Canada have taken this
initiative to convey important safety information about
VIAGRA to Canadian doctors.''

Pfizer Canada submitted VIAGRA for review and
approval by Health Canada in November 1997, six
weeks after the U.S. submission to the FDA. In contrast
to the U.S., VIAGRA was not eligible for priority
review because the condition it treats, erectile
dysfunction, is not life-threatening.

Health Canada has said its performance standard for
such a review is 300 days from its formal acceptance
after screening, which occurred in December 1997.

Pfizer is a global healthcare company dedicated to
research to develop products to treat unmet medical
needs and help people live longer, healthier and more
productive lives. It had sales of US$12.5 billion in 1997
and this year will invest more than US$2 billion in
research and development. Global headquarters are in
New York City where the company was founded in
1849. Pfizer Canada Inc. employs 1,000 persons across
Canada and is headquartered in Kirkland, Quebec.

(x) TM Pfizer Products Inc. - Pfizer Canada Inc.
licensee

For further information: Don Sancton, Associate
Director, Corporate Affairs, (514) 426-7063; Shellie
Suter or Rob Moore, Edelman Public Relations,
Canada, (416) 979-1120
17:58 ET

CNW 17:56E 09-JUL-98