As in Canada, the drug is approved in France for acne treatment. On Sunday, France’s health regulator - Agence Nationale de Sécurité du Médicament et des produits de Santé, better known as ANSM - announced it was investigating the use of Diane-35 after four deaths in the past 25 years had been linked to the drug. It is not approved for any use in the United States. The drug is reportedly routinely prescribed as birth control though it’s classified as a treatment for severe acne.
The majority were categorized as “serious.” The records show two 13-year-old girls experienced non-fatal clots deep in their veins that required hospitalization, as did more than 40 others. The fatalities were among 195 cases that cited adverse reactions where Diane-35 was the suspected cause. The records show that since 2000, 11 girls and women - aged 15 to 46 - who took the drug experienced severe and excessive blood clotting in their legs, sudden blockages in their lungs, bleeding in their brains and chest pain before death.
The Star reviewed nearly 200 adverse reaction reports for Diane-35 filed with Health Canada. The department is “reviewing the available information to determine the appropriate next steps,” a spokesman said. While France’s health authority has launched a sweeping investigation and announced plans to suspend sales of Diane-35, Health Canada said it hasn’t decided whether to follow suit. A popular acne drug under fire in Europe this week for its suspected role in the deaths of four French women may be linked to the deaths of at least 11 Canadians - including four teenagers, according to Health Canada records obtained by the Star.
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