PFIZER CANADA DISTRIBUTES LETTER TO CANADIAN PHYSICIANS
REGARDING VIAGRA-NITRATES CONTRAINDICATION
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
0- 07/09/98
For further information: Don Sancton, Associate Director, Corporate
Affairs, (514) 426-7063; Shellie Suter or Rob Moore, Edelman Public Relations,
Canada, (416) 979-1120/ CO: Pfizer Canada Inc. ST: Quebec IN: MTC SU:
30-
20:53 07-09-98 |
