Diane-35: Reconsidering the risks

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Publication Date: 
Thu, 2013-08-01

Health Canada’s review of the safety of the anti-acne medication Diane-35 has found that the drug’s benefits continue to outweigh the risks, when used as authorized. In Canada, Diane-35 is approved for the temporary treatment of severe acne—with associated symptoms of high levels of male hormone, including seborrhea (oily skin) and mild hirsutism (excessive body hair)—in women who are unresponsive to other available treatments. It should not be used in patients with a history that puts them at risk for blood clots, and is not approved for use as an oral contraceptive.”

Diane-35 contains a particularly high level of synthetic estrogen in comparison to other birth control pills on the market. It is believed that this is what creates the heightened risk of venous thromboembolism, a blood clot that forms in a vein due to blood coagulation that moves around the body and causes a life-threatening pulmonary embolism, or blockage in a main artery of the lung. When Diane-35 was originally released onto the market, the level of estrogen was similar to other pills containing a pairing of synthetic estrogen and synthetic progesterone.

Several assumptions underpin Health Canada’s chosen path in this case. The agency assumes that Diane-35 is an effective treatment for severe acne, which available research has not shown. Although the drug alleviates or moderates the severity of acne it does not treat its cause. Health Canada also assumes that the treatments currently offered by most doctors—pharmaceutical drugs and creams—are the only effective treatments available. This fails to recognize the evidence showing positive outcomes from lifestyle changes and complementary (non-pharmaceutical) acne treatments. Additionally, it is assumed that doctors will adhere to the rules outlined by Health Canada when prescribing this medication to women from here on. This remains to be seen. Lastly, there is the suggestion that venous thromboembolism is the only adverse effect worthy of concern; this ignores the fact that a powerful medication able to cause such a serious health problem is likely to have other adverse effects on the body.


“Diane-35 has been over-prescribed but this is just an extension of a wider problem. People barely think of the pill as a drug. It’s just become part of normal life. The advertising targets young teens like birth control pills are an accessory, like it’s the same as any other thing you would find in a young woman’s bedroom or purse.”

Some women are known to be more at risk of developing blood clots than others, including those who are overweight, older, who smoke, drink alcohol excessively, or have a genetic predisposition. Women with no other risk factors might be more likely to make the connection between a sudden serious health problem and their use of Diane-35. It is likely that the 11 deaths reported in Canada are not the total sum of injuries and deaths caused by the drug in this country but that there are a number going unreported every year due to lack of awareness.

Adrienne Shnier is a doctoral candidate at York University in Toronto, studying Health Policy & Equity in the School of Health Policy and Management. Shnier believes the causes of over-prescription are numerous and complex.

“Typically, if a patient knows what drug they want and describes their symptoms to their doctor, perhaps with a commercial or an online diagnosis quiz in mind, the physician will prescribe that drug within less than five minutes,” reports Shnier.  “There is no time for effective patient history discussion there or consideration of lifestyle factors that might make a doctor reconsider a prescription.”

When discussing an issue like acne, patients may insist on their own self-diagnosis of “severe” acne if their experience of the condition is causing enough anxiety. Couple that with a doctor who has been encouraged by drug sales representatives and marketing materials to prescribe this pill and you have a recipe for over-prescription.

Shnier’s work focuses on issues of conflicts of interest within the medical industry. Aside from the advertising directed at young women, doctors are also the targets of the drug company’s product promotion. “Studies have shown that something as simple as a pen given by a drug representative can make a doctor feel more favorably towards a medication,” says Shnier. Adding to this situation is that doctors rarely see or read all of the information available about the potential risks of a drug. They not only have little time to read everything that is available, but some of that information is not made available at all. “We have seen that pharmaceutical companies will suppress, lock away or destroy data that arises in research which presents their drug in an unfavourable light. Sometimes this information will only come out during litigation as a function of a trial,” Shnier says. “At the very minimum doctors need all of the data that comes from the research. Health Canada needs all of that data. Otherwise no one is making an informed decision.”

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