Viagra zipping toward Canadian approval
MARLENE HABIB
02/27/99
The Globe and Mail
Metro
Page A2
Toronto -- The anti-impotence pill Viagra has passed a major stumbling block and received a medical stamp of approval, a Health Canada spokesman said yesterday.
Approval of the drug in Canada is now a foregone conclusion and could happen in early March, suggested Dr. Hans Heich.
"The medical area has been approved," Dr. Heich, one of the federal govenment's medical evaluators, said from Ottawa.
Viagra is expected to receive a Drug Information Number some time in March, he added.
Of the three steps for getting government approval, medical clearance is usually the biggest hurdle.
But before Viagra can be sold in Canada, it still has to be scrutinized by the bureau of pharmaceutical assessment and pass labelling requirements.
Viagra , the first pill for erectile dysfunction, became the biggest selling drug in the United States after being introduced a year ago.
It's a novel alternative to the pumps, needles, suppositories and other invasive techniques used to stimulate blood flow in the penis needed to achieve and maintain an erection.
But its approval in Canada was delayed -- the initial target was the end of December -- because of adverse reactions reported in other countries where Viagra is prescribed, Dr. Heich said.
The drug, made by Pfizer, is already available in more than 50 countries. Some Canadian men have managed to get prescriptions filled in the United States.
More than 170 deaths worldwide have been linked to Viagra , although there's no conclusive evidence that the pill was to blame. The deaths most commonly involved patients using nitrates, such as nitroglycerine, for heart disease.
"There were more and more adverse reactions that had to be considered to get a summary of what is good and bad about it," Dr. Heich said.
Canadian researchers have since conducted their own trials, and Ottawa has now given Viagra the medical stamp of approval based on its assessment of whether the drug works, taking into account possible adverse side effects, he added.
Don Sancton of Pfizer Canada in Kirkland, Que., said passing medical scrutiny is good news for the approximately three million Canadian men with sexual problems.
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