The pharmaceutical contraceptive Diane-35, used in the US in some contraceptive products such as Nuvo ring, and produced in Europe and Canada by Bayer, is coming under additional scrutiny after numerous reported deaths by embolism.
Both Canadian and French authorities have requested studies of the drugs that have caused sudden death in at least 15 women.
The drug, which is known for its off label use in treating acne, a practice widespread both in Europe and Canada, has caused a discrete uptick in the numbers of fatalities of the patients using the drug.
Four of the deaths were of teenagers, who were using it to clear their acne.
The findings have prompted a sweeping inquiry and a plan to suspend all sales of the drug in France. Canada has not yet said if it will follow suit.
200 adverse reactions have already been tallied for Diane-35 users. Most of these reactions were serious. Although only 15 of the 200 patients died, at least two of the patients,13 year old girls, experienced deep vein blood clots.
The use of the drug was not approved in the United States but some non oral contraceptives in the US contain a percentage of the compound in Diane-35.
Various studies have indicated that Diane-35 does carry a higher risk than other contraceptives of blood clot complications.
Bayer, on their part, reiterated the safety of Diane-35, and cited a lack of change in the risk assessment of the compound.
Its use in fact, has chiefly been relegated to the treatment of acne that does not respond to any other medication. But its chemical property is that of a contraceptive.
Even though a Canadian study did highlight the medication's higher risk of blood clotting, doctors continued to widely prescribe the medication for acne and birth control. Some patient actually used it as a birth control measure and an acne prevention, after initially trying it as an acne preventer.
Source: Toronto Star 4.22.13
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