France’s health regulator has opened an inquiry into acne drug Diane-35, which is also used as a contraceptive, after four deaths were linked to the drug in the past 25 years.

Health regulator ANSM said on Sunday that the four deaths were due to thrombosis, or blood clots, linked to the use of Diane-35. Three other deaths that had been connected to the drug were actually linked to other health issues, the agency said.

Diane-35, also sold as Dianette in some countries, reduces acne for women by regulating hormones. The drug is also used as a contraceptive.

Diane-35 is produced by German drug maker Bayer. It is authorized in 135 countries and sold in more than 116.

In Canada, the drug has been available since 1998. But according to Health Canada it should only be used to treat severe acne and not as a method of birth control.

Its launch in Canada coincided with a marketing campaign on billboards, bus shelters and television aimed at young women. The sales pitch was that Diane-35 was as an acne medication that also worked as a birth control pill. Sales soared — up 45 per cent between 2000 and 2001, according to the Canadian Medical Journal Association, which has also expressed safety concerns about Diane-35.

Since its release, the Canadian health agency has, on various occasions, highlighted concerns regarding the use of Diane-35 and the risk of blood clots.

In December 2002, Health Canada warned about increased risk for venous thromboembolism, including deep vein thrombosis and pulmonary embolism.

In May 2005, it again warned that Diane-35, along with all estrogen/progestogen combinations, should not be used by women with thrombophlebitis, thromboembolic disorders (blood clots), or those with a history of these conditions.

Smokers are at increased risk — a risk that goes up after age 35 and if someone smokes 15 or more cigarettes per day.

Health Canada also warns that oral contraceptives should not be taken by women who are on Diane-35 for treatment of acne. And, Diane-35 should be discontinued three to four months after the acne has cleared up.

Loading... Loading... Loading... Loading... Loading... Loading...

Read more about: