27 Women Die From Off-Label Contraceptive

Commentary by Susan Brinkmann, OCDS

A hormone pill called Diane-35, manufactured by Bayer to treat acne but used off-label as a contraceptive has been implicated in the deaths of 27 women in Europe.

LifeSiteNews is reporting on the Netherlands Pharmacovigilance Center, which tracks adverse drug reactions in European nations, which believes Diane-35 is responsible for the deaths of dozens of women in Europe. Most were under the age of 30 and died of either a pulmonary embolism or thrombosis after the drug caused clots to form and become lodged in their brains, hearts, or lungs.

“Earlier this year, France banned the drug after four women died and more than 100 developed potentially fatal blood clots after taking it, but European Union health officials ordered the country to lift the ban in July, ruling that the benefits of the drug outweigh the risks when taken as indicated to fight acne or unwanted hair growth.  However, the EU commission warned that off-label use of the drug as a contraceptive was not advisable,” LifeSite reports.

As is commonly the case with synthetic hormonal drugs used by women as contraceptives, Diane-35 continues to be sold even though there is a long history of deaths and serious injury associated with it.

As LifeSite reports, the UK issued a warning about deep vein thrombosis associated with the drug as long ago as 2001. A Danish study conducted in 2009 found patients’ risk of blood clots increased almost sevenfold within the first year of use. France banned the drug earlier this year after its health watchdog group, the ANSM, linked it to 2,500 potentially fatal blood clots. This decision was overruled by the European Commission in Brussels which ordered the country to lift the ban but instruct physicians not to prescribe it as a contraceptive, only as an acne treatment. The drug is currently under investigation in both Australia and Canada.

The seriousness of the situation is apparent in the sad story of 18 year-old Marit McKenzie from Canada who died earlier this year after taking Diane-35.

Her father, Bruce McKenzie, says that in the weeks before her death, his once-active teenager began complaining about fatigue. One night, her heart rate jumped to 145 and she couldn’t breathe. He carried her to the car and then straight into the hospital where she suffered four heart attacks before doctors realized she had an embolism blocking blood flow to her lungs.

“The emergency room doctor read the [CT] scan herself,” Bruce told the Toronto Star. “She said in front of all of us: ‘I see nothing. There’s nothing. She must have gone toxic. Pneumonia? A bad infection of some kind?’ And then an intern piped up: ‘She’s taking birth control medication.’”

After that, the clots were finally discovered, but it was too late for Marit. Two days later, she suffered a brain hemorrhage and died.

“The thing that makes me angry is my daughter didn’t have severe acne but it got prescribed anyway,” Bruce told the Star.  “When I tell people about the drug, because I tell everybody I can, when you explain to them that it’s only allowed for acne in Canada but, oh, by the way it’s also an oral contraceptive, they look at you like, ‘What?’  So you explain to them the insidiousness of this — that young women who maybe want to be sexually active have a really nice way of telling their parents they’re taking it for acne.”

Marit was one of 13 other Canadian women who died after taking Diane-35. Eight of these women were under the age of 21 years. Another 165 have suffered serious injury or permanent disability from the drug.

Although Health Canada has issued three safety warnings about the drug, each time they conduct an investigation they conclude by ruling that the drug’s benefits outweigh the risks. Unfortunately, Canadian authorities do not release the details of these investigations to the public, which is most upsetting to parents such as Bruce McKenzie.

“That makes me very mad,” Bruce McKenzie told the Toronto Star. “Information is so important. … Health Canada’s job is to protect people. I accept the fact that you’re not going to take it off the market because my daughter died but at least give women the right to make an informed choice.”

An informed choice about drugs targeting “women’s reproductive health” is a rarity in today’s world where the suppression of vital safety information is deemed less important than the suppression of ovulation.

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