THE HAGUE, October 28, 2013 ( – Diane-35, a controversial hormone pill intended to treat acne and excessive hairiness in women, but often used off-label as a contraceptive, has been implicated in the deaths of 27 women by the Netherlands Pharmacovigilance Center at Lareb, which tracks adverse reactions to medications in the European country.

The majority of the women who died were under 30 years old, and most died of pulmonary embolism or thrombosis after the drug caused blood clots to form in their bodies which then became lodged in their brains, lungs or hearts.   The pill has also been linked to depression by researchers in the UK.   

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.


Diane-35 and its manufacturer, Bayer, have also come under fire in other countries as women, most of them young and otherwise healthy, continue to die from side effects of the drug.  In 2001, the UK issued a warning about the risk of deep vein thrombosis associated with Diane-35, and a 2009 study in Denmark showed that patients’ risk of such blood clots jumped nearly sevenfold within the first year of use. Both Australia and Canada have launched inquiries into the safety of Diane-35 within the past year, prompted by the French ban and increasing activism by parents who have lost daughters to the drug.

In Canada, one such parent is Bruce McKenzie, whose daughter, Marit, an 18-year-old freshman at the University of Calgary, died January 28 after less than a year of taking Diane-35. 

Click “like” if you are PRO-LIFE!

In the weeks before her death, the once-active teenager had become progressively weaker, complaining of constant fatigue, until one night she used her cell phone to call Bruce in a panic from the bottom floor of the family’s home to report that her heart rate had jumped to 145 and she could not breathe.  

Bruce rushed downstairs, carried Marit to the car and took her straight to the hospital, where she suffered four heart attacks before doctors realized she had a massive 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, a radiologist reviewed the scan and discovered the clots.

Two days later, Marit was dead.  Despite her doctors’ best efforts to save her, her brain hemorrhaged, ending her life. 

“The thing that makes me angry is my daughter didn’t have severe acne but it got prescribed anyway,” Bruce told the Toronto 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.”

In death, Marit joins 13 other Canadian women whose lives have been prematurely ended by Diane-35 since 2000, according to Health Canada’s adverse events database.  Eight of those women were under 21 years of age.  Another 165 have suffered serious injury or permanent disability from the drug.

Canada has launched several investigations into the safety of Diane-35 during the last ten years, but each time, the health agency has ruled, like the EU, that the drug’s benefits outweigh its risks.  However, unlike the European and United States’ drug safety commissions, Canada refuses to make the details of its findings public, citing “confidential business information.” 

“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.”

As for the drug’s manufacturer, Bayer, the company told the Star it extends its “deepest sympathies to the women and their families who feel that they have been adversely affected by Diane-35.”

But just six days after Marit McKenzie’s death, in response to the French ban and a fresh round of worldwide scrutiny, the company released a statement – curiously labeled ‘Not intended for U.S. and UK Media’ – which said of the drug, “we believe that Diane-35 has a favorable benefit-risk profile when used in accordance with the label. We are not aware of any new scientific evidence leading to a change in the positive benefit-risk assessment of Diane-35.” 

The company added, “While Bayer is of course collaborating with the respective health authorities concerning the use and the benefit risk profile of Diane 35, we fully stand behind Diane-35.”