Health Canada is currently reviewing all available safety information on Diane-35 after the drug was linked to the deaths of four French women and at least 11 Canadians, according to Health Canada records obtained by the Toronto Star.
Diane-35 is an acne treatment, also used off-label as a form of birth control.
The French National Agency for Medicines and Health Products Safety (ANSM) announced it will suspend sales of the drug in three months. In the interm, doctors are banned from prescribing it.
The drug has been sold in France for the last 25 years.
According to the ANSM, the deaths were a result of venous thromboembolism (VTE). VTE refers to a clot forming in a blood vessel.
In Canada, Diane-35 is only approved to temporarily treat severe acne, however it is also serves as an oral contraceptive.
Between 2002 and 2005, Health Canada released three press releases warning of increased risk of severe blood clotting.
“The drug should not be promoted nor used as a method of birth control,” the third release cautioned.
While the drug is approved to treat acne, Health Canada recommended it stop being taken after three to four menstrual cycles.
Diane-35 is not approved by the U.S. Food and Drug Administration (FDA).
Jesse Cook, a second-year journalism and french student at Carleton University, said she had to stop taking different birth controls twice because of side effects that occurred.
“It’s frightening that Health Canada has not decided to discontinue the drug yet,” Cook said.
Cook said at the very least, doctors should warn patients when prescribing this drug of the serious side effects that have been associated with it.
Jessica Mullin, a second-year law and sociology student, said that since the age of 13 she has tried several different types of birth control. After some research, she learned one of them caused dangerous side effects, such as weight gain of up to 100 pounds.
“Patients don’t necessarily have the means of figuring out for themselves what is dangerous. You’re relying on the government to figure that out for you,” Mullin said.
Until the review is over, Health Canada said it will not suspend sales of Diane-35. However, they urge anyone experiencing symptoms of a blood clot to seek immediate medical attention.
