Health Canada asks for more information as it considers application to sell RU in Canada

 

By Dave Andrusko

Canadian Health Minister Rona Ambrose

Canadian Health Minister Rona Ambrose

It may be, and likely is, only a temporary stay, but earlier this month Health Canada asked for more information from the European drug company that has applied to sell RU-486 in Canada.

The request, made of Linepharma International, means the federal regulator is unlikely to issue a ruling until later this year, the Globe and Mail reported, and unlikely to “hit the market” until 2016.

Working in close collaboration with the National Abortion Federation, Linepharma International is applying to sell both RU-486 (mifepristone) and misoprostol, a prostaglandin that induces contractions to expel the dead baby.

The news that Health Canada, the department led by Health Minister Rona Ambrose, was delivered to the media by Vicki Saporta, the president of the National Abortion Federation (NAF).

“Certainly, we’re disappointed with the delay,” Saporta told The Globe and Mail in an interview. “But I’m very optimistic that, at the end of the day, Health Canada will approve mifepristone and it will be available for Canadian women to use next year. We’re making forward progress.”

According to The Globe and Mail’s Kelly Grant, NAF represents 80% of abortion providers in Canada.

Grant emailed Marion Ulmann, Linepharma’s chief operating officer, about the postponement. “So far the registration procedure has gone uneventfully along with usual Health Canada procedures and there is no predefined date for the end of the procedure,” she said.

The application, if approved, would authorize the use of mifepristone by prescription up to nine weeks.

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Supporters tout that the “abortion pill” is legal in many countries, including the United States.

Opponents rejoin that RU-486 has a lengthy track record of injuries to women and deaths. The last formal update from the FDA was in 2011.

But even by then, in the United States alone, 14 women had died since September 2000 while another 612 were hospitalized. There were 339 cases in which blood loss was serious enough to require transfusions, according to the FDA.

The FDA reports 256 cases under the category “infections.” In the accompanying footnote, we learn this includes very serious stuff– endometritis, pelvic inflammatory disease, and pelvic infections with sepsis (“a serious systemic infection that has spread beyond the reproductive organs”).

But 48 of these were labeled “severe infections.” The footnote explains that “severe infections generally involve death or hospital for at least 2-3 days, intravenous antibiotics for at least 24 hours, total antibiotic usage for at least 3 days, and any other physical or clinical findings, laboratory data or surgery that suggests a severe infection.”

Overall there were 2,207 “cases with any adverse event.” Those included 58 ectopic pregnancies which are extremely dangerous.

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