Oral Contraceptives: What You May Not Be Told

If you are taking Diane-35 for birth control, ask yourself:"Why take an acne medication if I don’t have to?"

I met some girlfriends at a bar for a few drinks and the topic of
conversation sent me home searching for answers. The worry set in when a friend asked how many of us were using Diane-35 as an oral contraceptive.

When five out of six said yes, including myself, she revealed that her friend’s physician had taken her off the drug following an advisory posted by Health Canada.

I visited Health Canada’s Web site and read the advisory, which stated that Diane-35 should NOT be used solely as a birth control pill. The drug is meant as a treatment for women with severe acne who are unresponsive to oral antibiotics. Women should stop taking the drug three to four cycles after the condition has cleared. Evidence suggested Diane-35 users have a greater risk of developing venous thromboembolism (moving blood clots) than users of low-dose, combined oral contraceptives. The drug has never been approved in Canada as an oral contraceptive. Why, then, are so many women taking Diane-35?

Berlex Canada, the manufacturer of Diane-35, did not wish to comment.

A spokesperson for Health Canada explained that increase in sales is due to doctors prescribing Diane-35 for its "off label" use–the drugs’ contraceptive properties. A spokesperson for the College of Physicians and Surgeons of Ontario (CPSO) said that "it’s within the physician’s clinical judgment to prescribe drugs for their off label use as long as they provide sufficient information to the patient about the drug."

Women must know that blood clotting is a serious side-effect of any combined oral contraceptive. However, the Society of Obstetricians and Gynecologists of Canada (SOGC) stated in a recent press release that the risk of developing clots is no greater than from smoking or being overweight. They were concerned that a report on CBC’s Disclosure program may have scared users of Diane-35 into stopping medication. The report stated that women taking Diane-35 have a higher risk of developing blood clots than women using other oral contraceptives. The SOGC feels that CBC based its findings on an "incomplete scientific report” that may have put a number of women at risk for unintended pregnancy. The SOGC is aware that Diane-35 should not be used solely as a contraceptive.Julie was diagnosed with deep vein thrombosis (DVT, blood clots) and feels Diane-35 may have contributed to the clotting. Her doctor recommended the drug as a contraceptive although she has never required a drug to treat acne.

She discovered unusual swelling in her left leg and thought it was a pulled muscle. "As the day progressed, I couldn’t bend my leg or feel my foot. My leg was three times its size, bright red and literally felt like it was going to explode,” explained Julie. She went to a walk-in clinic and the doctor immediately recognized that her condition was life threatening. When she arrived at the hospital, she was diagnosed with DVT.

"I was told I had eight to 10 clots in my leg. I was taken off the birth control pill immediately and told I could never use it again," explained Julie. She still has clots in her leg, though they are slowly dissolving. "This has been the scariest time of my entire life. I thought it would never happen to me."

According to Dr. Vlasblom, a family physician in Brockville, Ont., "all doctors should take patients off Diane-35 if they’re using it solely for its contraceptive properties." He believes any doctor continuing to prescribe Diane-35 as a contraceptive could be reported to the CPSO. A spokesperson for the CPSO stated that doctors are ultimately responsible for every prescription they write. If a patient has a complaint about care or treatment provided by a doctor, she can report the incident to the CPSO.

Health Canada is continuing to monitor the safety of Diane-35, but at this point feels the drug is not risky enough to take off the market. "There have only been 23 cases of adverse health effects reported on the drug since November 2001," said a spokesperson. Doctors who receive Health Canada’s e-mail subscription will receive the advisory about Diane-35. Visit hc-sc.gc.ca for more information.

The Society of Obstetricians and Gynecologists of Canada believes every woman should talk with her doctor before stopping medication to discuss whether the benefits of Diane-35 outweigh the risks. If you are taking Diane-35 for birth control, ask yourself: why take an acne medication when you don’t have to? "The drug has never been approved in Canada as an oral contraceptive. Why, then, are so many women taking Diane-35?"