Checking out birth control

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Bayer Inc., producer of oral contraceptives Yaz and Yasmin, is the subject of a proposed class action lawsuit over health risks and misrepresentation of those risks.
Bayer Inc., producer of oral contraceptives Yaz and Yasmin, is the subject of a proposed class action lawsuit over health risks and misrepresentation of those risks.
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Yasmin and Yaz, two popular oral contraceptives, have become the target of a lawsuit alleging they cause serious health side effects in women. Matthew Baer, a lawyer at London, ON firm Siskinds LLP, is heading the class action lawsuit against Bayer Inc.—the producer of Yasmin and Yaz birth control.

Baer said hundreds of women contacted his firm, claiming the products caused side effects like stroke, blood clots, heart issues and gallbladder issues.“When we got our first few calls, we didn’t think much of it because there is risk of having these types of issues on any oral contraceptive,” he said. “But then as you start getting more and more, and it’s always the same pill, you start to look into it further.”

The case was filed last spring and is awaiting a certification hearing to decide whether claims that Yaz and Yasmin had higher risks of serious health problems and users were not adequately informed are legitimate for a class action. Baer said the lawsuit is based on the premise that Bayer didn’t give sufficient warning of their product’s potential side effects.

“That’s really the key issue, having a proper warning in place so people can make informed decisions about what’s best for them,” he said. “Because if you know that the risks were high with one compared to another, and they’re equally effective at preventing pregnancy, you’re probably going to take the one with the lower risks.”

Bayer Inc. released the Yasmin birth control in Canada in 2004 and the Yaz birth control in Canada in 2009. Laura Burns, senior business communications partner at Bayer said, “Bayer Inc. acknowledges the lawsuit and is in the process of gathering information on the cases.”

Dr. Shurjeel Choudhri, vice president and head of medical and scientific affairs at Bayer, said the company’s internal testing is very rigorous and shows no proof that their medications pose a danger to women. “All I can say is that we’ve looked carefully at our clinical data, as well as post-marketing data, and we don’t find any evidence that there’s any increased risk for Yaz compared to the other birth control pills.

“Every birth control pill has with it an increased risk of blood clots,” he said. “It’s a small risk, somewhere around four per 10 thousand women users, which is a much lower risk than say, a woman getting pregnant. “Were you to read the label of any combined oral contraceptive, this is one of the things that is listed for all of them,” he said.

Yasmin contains 30 mg of estrogen taken for 21 days with a seven-day placebo dosing, while Yaz contains 20 mg of estrogen and is taken for 24 days with a four-day placebo dosing. “We believe in women having options, and each one of these has different benefits,” Choudhri said, adding that Bayer tests their product continually in accordance with Health Canada standards that require all tests to be reviewed by Health Canada’s Therapeutic Products Directorate.

“There’s no evidence that the risk of blood clots is any different,” he said. “We do the clinical trials that Health Canada needs for the approval of the product … we also monitor adverse event reports that are reported in by women all across the world. Again, with all of those things being very closely monitored, we don’t find any evidence there for increased risk.” Baer said the adverse event reports Bayer receives are probably an underestimate of people actually affected by the product.

“Their company would be collecting adverse event reports, but even those are typically vastly underreported. It can take some time, because these are things that can happen to someone even if they’re not taking this particular pill. It’s not like a signature disease. For example, if someone has mesothelioma, you know that they’ve been exposed to asbestos. You don’t have that sort of correlation here, so it takes longer for people to realize what the cause is.”

A Facebook page, titled “Take Your Body Back,” was created in promotion of the class action suit, and has over 3,000 supporters. Choudhri said media attention on the case, which has been reported on by major news outlets including the Globe and Mail and CTV, skewed the number of negative reports from consumers.

“Adverse event reports are highest in the first year or so of a product entering the market, and then they tend to trail off. And obviously, you can get increases in adverse event reporting if there’s specific media attention on a topic.” Suzanne Billing, medical director for Queen’s Health, Counselling and Disability Services, said because the Bayer products—specifically Yaz—are relatively new to the market, the lawsuit isn’t surprising. She said risks of vascular thrombotic events, a form of blood clotting, are no greater with Yaz or Yasmin than with any other oral contraceptive (OCP) with similar estrogen levels.

“The lawsuit touted in the media is not the first which has arisen with newer OCPs; it is likely because of the clustering effect,” Billing told the Journal via email. “The risk of these vascular events is highest in the first year of use and this skews data when a new OCP is introduced since all are in the first year of use and there is often a ‘rush’ on a new OCP, so the vascular events (which occur with all of the combined OCPs) are clustered, making it appear that they occur more frequently.”

Billing said women often experience minor side effects from using birth control pills, but major health problems are rare. “In general, they are well tolerated with few side effects; nausea is the most common adverse effect but it generally self-resolves early on,” she said. “Mood changes and weight gain are uncommon but are often issues of concern to women starting oral contraceptives, and frequently asked about. There is a long list of less common side effects/risks including vascular thrombotic events (VTE).”  

“I switched to Yaz [because] I heard from friends that it worked better with [fewer] side effects,” said a Queen's student who started taking Yaz last November after three years on a different oral contraceptive. During a gynaecologist visit, the student asked to try out Yaz, on the advice of a friend. She said the doctor treated her differently than when she began taking birth control a few years ago with her family doctor.

“I was seeing him for something else, and at the end of the appointment I said ‘oh, by the way, I think I want to go back on birth control pills and I think this is the pill I want to take,’ and that was it. He didn’t say, ‘oh, people have said this about Yaz’ or [anything] like that ... all he did was hand me a pamphlet for Yaz, he didn’t give me any information himself.”

She said her family doctor was much more thorough and comprehensive in explaining her options when she first went on a form of oral contraceptive. “I was 14 or 15,” she said. “He went through all kinds of different types ... [and] asked me all these questions before he put me on one. So that’s a huge difference.

“I don’t know if they’re maybe treating me different because of my age. Maybe they ethically feel more responsible when you’re younger. Now that I’m older, maybe they think ‘oh, she knows what she wants; let her make her own decisions.’ I don’t know if it’s different because they want to be responsible.”

The student said she decided to stop taking Yaz a couple weeks ago after a quick and unexpected weight gain. “I didn’t really notice any hormone changes. I didn’t notice any changes in my behaviour at all when I started taking Yaz. It was a little more balanced, it was effective. The only real difference, I had absolutely no change in my lifestyle, but I gained weight very rapidly.”

“I wasn’t really trying to eat healthy or anything; because I wasn’t overweight, so I could just eat whatever I wanted. But then I went on the pill and all of a sudden became overweight rapidly.” The student said she would have liked to have been better informed about the potentially severe health effects associated with the use of certain oral contraceptives.

“He should have warned me about the risks for taking an optional drug [like birth control], because it’s not like I needed it to save my life or anything. It’s just something I could live without, and had lived without for years, so it would have been nice to hear any possible [health] effects, especially when they’re that serious.”

Baer said he’s concerned about campaigns to market the product. “There’s no question that they’re marketed heavily toward young women,” he said. “Even in Canada [where direct-to-consumer marketing is not allowed], they hired Lo Bosworth from the Hills as their spokeswoman to try and promote Yaz.”

Peter O’Neill, Queen’s Obstetrics and Gynaecology professor and practicing doctor, said doctors are required to have discussions with patients before prescribing a drug. “Prescribing anything you have to discuss the risks and benefits of it,” O’Neill said, adding that he would consider prescribing Yaz or Yasmin. “It would depend on the individual patient.” He said the Queen’s students he sees as patients are usually informed on the risks, benefits and options associated with contraception. “They’re a very knowledgeable group and I think they’re a very articulate group.”

Queen’s Health Couselling and Disability Services can be reached at (613) 533-2506.

The name of the Queen's student has been removed at her request and at the permission of the Editors in Chief. July 7, 2016. 

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