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