Blog of the Society for Menstrual Cycle Research

The Other Dangers of Yasmin and Yaz

July 2nd, 2013 by Holly Grigg-Spall

Recently, in a piece for the Ms. Magazine blog, re:Cycling’s Elizabeth Kissling remarked on the lack of media coverage of serious safety issues with the popular birth control pill brands Yaz and Yasmin. Of the coverage there has been, little has looked beyond the significant number of injuries and deaths caused by blood clots to the potential dangers held in the negative psychological impact of these drugs, an impact that it appears a large number of women may have experienced.

As I read the stories of women who had suffered strokes or gone blind, I wondered how many women using Yaz or Yasmin had also been driven close to death, or perhaps even died, due to the depression the pills can provoke.

I decided to interview Dr Jayashri Kulkarni at Australia’s Monash University, one of the few people researching into this area, to find out more. As a practicing psychiatrist Dr Kulkarni treats women with mental health issues as well as leading research studies into this possible root cause of psychological problems.

Of the potential for these pills to create suicidal tendencies in users Dr Kulkarni says, “We have seen amongst women using these oral contraceptives a profound lowered self-esteem which causes them to lose perspective, misinterpret comments, and feel like no one would notice, or the world would be better off, if they weren’t around anymore. We’ve seen suicide attempts.

Dr Kulkarni is undertaking both a large-scale national and international survey of women’s subjective experiences with Yaz, Yasmin, as well as the Mirena IUD, Depo Provera shot, and Implanon implant and a smaller scale in-clinic study of the impact of oral contraceptives like Yaz and Yasmin on women over a three month period. The psychological impact is not what she calls “major depression” but instead a “sub-clinical depression” wherein women experience a mood change that impacts their relationships, work, and overall happiness.

“This depressive syndrome has a spectrum of symptoms. We tend to think depression just means sadness, but it can present as fuzzy headedness, inability to multitask, guilt, irritability, anxiety, and in behavioral changes like the development of obsessive compulsive disorders. Women experience a change in perspective that makes them magnify issues that occur in their lives, be that a slight weight gain or an argument with a partner, into feelings of worthlessness. It can also cause impulsivity, making the woman suicidal.”

At her clinic Dr Kulkarni describes treating a mother who found it difficult to let her children go to school for fear something would happen to them and another who became transfixed with the idea that her partner was cheating, and so called his phone repetitively to check on him. She believes that the provoked anxiety can display itself clearly as panic attacks, but it can also appear as paranoia and agoraphobia. When taken off Yasmin and Yaz these women returned to their previous state with a healthy perspective.

The Depo Provera shot and Implanon implant have shown in the research to also cause particularly profound depression. For women who have a history of mental health issues or have environmental factors that make them more vulnerable to mental health issues, these methods have been seen to provoke serious negative changes in mood.

Dr Kulkarni’s hypothesis is this: “Low estrogen pills and progesterone-only methods seem to cause depression at the highest rate. In our research we’ve seen women respond better to higher dose estrogen and natural progesterones. Clinical studies on animals have shown progesterone in a low dose causes increased anxiety, but conversely in a high dose it alleviates anxiety.” Her findings will be published later this year in full.

At present Dr Kulkarni treats her patients by changing their hormonal birth control method with her research in mind, a practice she believes to be generally successful. She prescribes new pill Zoely to patients who have responded badly to other brands. Zoely (which contains 2.5 mg of nomegestrol acetate and 1.5 mg of 17-beta-estradiol) was refused approval by the FDA for the US in 2011.

Yaz and Yasmin: An Unacceptable Level of Risk?

June 25th, 2013 by Elizabeth Kissling

Photo by Flickr user Beautiful Lily // Creative Commons 2.0

Don’t feel bad if you missed last week’s headline news about the deaths of 23 young women from their birth control. It was a top story for CBC news and a few other Canadian sources, but it was barely a blip on the radar of most U.S. news outlets. Yaz and Yasmin, two similar new-generation birth control pills from Bayer, are suspected in the recent deaths of these young Canadian women.

These are among the best selling oral contraceptives in the world, but this is not the first time Yaz and Yasmin have been suspected of causing death or adverse effects. Earlier this year, Bayer agreed to pay up to $24 million to settle claims from plaintiffs with gall bladder injuries caused by the drugs, and the company set aside $1 billion to settle claims from approximately 4,800 women who have suffered blood clots due to Yaz or Yasmin. As of February, 2013, approximately 10,000 lawsuits against Bayer are still pending in the U.S., and an additional 1,200 unfiled claims are pending. The company anticipates additional lawsuits—and additional settlements—regarding blood clot injuries, such as pulmonary embolisms or deep-vein thrombosis.

The history of the birth control pill and its social impact is well documented. First approved by the U.S. Food and Drug Administration in 1960, it quickly became the world’s first “lifestyle drug,” and it has become the one of the most studied drugs in history. It is considered to be so safe that the American Congress of Obstetricians and Gynecologists (ACOG) recently recommended that oral contraceptives be sold without a prescription.

But all hormonal contraceptives–the pill, the patch, the shot and the vaginal ring–carry a risk of blood clots. For most users, this is a minor concern, affecting approximately six of every 10,000 pill users. For users of new-generation pills—that is, pills containing drospirenone, the fourth-generation synthetic progesterone found in Yaz, Yasmin, Ocella and several other brands—the risk jumps to ten of every 10,000 users, although Bayer maintains that their own clinical studies find the risk comparable to older pills. Note, however, that the risk in most of these studies is compared either to other hormonal contraceptives or to pregnancy, not to using effective non-hormonal contraception. As if women’s only choices were to be pregnant or be on the pill.

And it is this matter of women’s choices that brings me to my main point: Why we have we seen so little media attention to the safety profile of Yaz/Yasmin (and hormonal contraceptives more generally)? This isn’t about just a few unlucky Canadian women: Four women in Finland have died, more than 50 U.S. users of Yaz and Yasmin died in just a few years and France reports 20 deaths per year due to birth control pills between 2001 and 2011, with 14 attributed to the new-generation contraceptives. This is a major consumer safety concern, and a women’s health issue.

In an earlier time, this might have led to Congressional investigations, such as the Nelson Pill Hearings, which resulted in FDA-mandated Patient Package Inserts (PPIs)—the printed information about risks, ingredients and side effects included in pill packets, first required for oral contraceptives and then for all prescription drugs. It is hard to imagine today’s Congress calling for such an investigation. Among many other social changes since 1970, drug manufacturers in the U.S. hold more influence over both legislators and consumers, now spending nearly twice as much on promotion as they do on research and development.

A parallel can be found in the health crisis triggered by an outbreak of Toxic Shock Syndrome (TSS) linked to tampon use in 1980. TSS is a potentially fatal infection caused by bacterial toxin Staphylococcus Aureus. A new brand of superabsorbent tampon was linked with 813 cases of TSS, including 38 deaths, that year. By 1983, the number of menstrual-related cases reported to the CDC climbed past 2,200, and manufacturer Proctor & Gamble had “voluntarily” pulled the product from the market before the FDA forced them to do so. The intense media coverage, public concern and outcry from feminist activists pushed the FDA to reclassify tampons as a Class II medical device, an upgrade which meant tampons would require more specific regulation and possibly after-market surveillance. They were much slower to mandate absorbency standards, but eventually did so under court order. These actions resulted in a documented decrease in menstrual-related TSS, although it is important to note that it has not disappeared.

Today, more than 30 years later, young women are again dying from something purported to help them, something that affects mostly women. Thousands more are experiencing life-threatening, health-destroying side-effects, such as blindness, depression and pulmonary embolism. Canada’s professional association of OB-GYNs defended the drug, suggesting that perhaps the recent deaths could be attributed to non-contraceptive reasons for which it was prescribed, such as PCOS or diabetes, both of which are associated with higher risks of blood clots. But there is little evidence of public concern, outside of Yaz/Yasmin user message boards. Even feminist outlets aren’t always covering these issues as vigorously as we might hope.

Yet the birth control pill in general has never been more politicized in the U.S.: In the last year or so, we’ve seen headlines and public debates about insurance coverage of the pill, access to emergency contraception and so-called personhood bills which have been introduced in legislatures in at least eight states. Feminist activists and health care advocates have been working tirelessly to protect access to the pill along with other forms of birth control, as well as the right to end an unintended pregnancy—and feminist journalists have been writing about these activities.

In the urgency of responding defensively to these political attacks—and we must respond—feminists cannot ignore corporate threats. Just as preserving contraceptive and abortion access is critical to women’s health and well-being, so is protecting contraceptive safety.

Cross-posted from Ms. magazine blog.

Footloose and Pharmaceutical-Free?

October 26th, 2012 by Elizabeth Kissling

Guest Post by Holly Grigg-Spall, Sweetening the Pill

At the West Coast Catalyst Convention for sex-positive sex-educators I was listening to a talk on definitions of sexual health when the birth control pill was brought up. I’d spent much of the event feeling desperately vanilla and so was pleased to be discussing something other than strap-ons and lube. The most popular forms of contraception – the hormonal kind – had been notably absent from all discussion that weekend.

Toys in Babeland window display, Photo by Joaquin Uy // CC 2.0

The speaker told the group that the pill is the leading cause of low libido and pelvic pain. She explained that studies had suggested the impact on libido could be permanent. The reaction of the audience was immediate and urgent – questions were fired out and it became clear that this information was news to most. A number of audience members seemed genuinely shocked. “What’s the science behind that?” one woman asked, but the speaker said she didn’t know.

Although the convention’s attendees had an intimidating level of knowledge when it came to sexual technique and sex toys, I discovered that once I mentioned I was there to develop a book and a documentary on hormonal contraceptives, many repeated the usual disinformation about birth control methods.

The speaker was right – the birth control pill is a leading cause of lowered sexual desire and pelvic pain. It’s also known to cause loss of lubrication, vaginitis, and vulvodynia. Other hormonal contraceptives such as the Depo Provera injection, implant, ring and Mirena IUD have been seen to have similar consequences. In fact, Dr. Andrew Goldstein, director of the U.S.-based Centers for Vulvovaginal Disorders and one of the foremost vulvodynia experts in North America, blames an increase in complaints of this kind on third generation low-dose pills.

The study the speaker referred to was conducted by Dr. Claudia Panzer of Boston University and it did suggest some women may see a permanent effect on their testosterone levels, and so their level of desire. There have also been studies on these methods impact on frequency and intensity of orgasm, showing both to be decreased. Not to mention the 50% of women who will experience general negative mood effects that surely impact on their interest in sex. Many, many other studies have shown a clear negative effect on libido whilst using hormonal contraceptives. So many that it’s become something of a joke to roll eyes over the “irony” of prescribing a pill for pregnancy prevention that stops you wanting to have sex anyway.

At a convention dedicated to the celebration of sexual pleasure, I was surprised to see this information received with such confusion. A sex-positive attitude is becoming synonymous with “set it and forget it” long acting hormonal methods of contraception. But it struck me that sex-positive advocates should be the biggest fans of fertility awareness methods. Here’s why:

What’s missing from Mother Jones’ birth control calculator?

February 22nd, 2012 by Elizabeth Kissling

Source: Public Domain

In response to Rick Santorum’s recent assertion that birth control only costs “a few dollars” and therefore there shouldn’t be such a big fuss about denying insurance coverage, Mother Jones published a birth control calculator this week that estimates your lifetime costs for birth control, based on your current age. The calculator asks you to enter your age and then select your preferred method. Options include the pill, IUDs, Implanon, injections, the patch, the vaginal ring, and surgical sterilization. (It doesn’t specify sterilization for women or for men, but given the context of the current debates, I’m assuming the calculator estimates only the cost of female sterilization.) It also fails to take into account that, in reality, most women use more than one method throughout their reproductive years.

Now, I know that aside from the cost of reference books, charting supplies, and perhaps a course or two to get started, using Fertility Awareness Methods is free, but condoms and spermicide aren’t. And as NPR reported on Tuesday, it can be difficult or inconvenient to get those methods covered by health insurance. Diaphragms and cervical caps aren’t cheap either, and they both require physician visits to be properly fitted. Diaphragms last a long time, but they do need to be replaced every few years. It’s been a while since I needed one, but I’m pretty sure that my health insurance covered the cost of my diaphragm, although I had to pay out-of-pocket for the accompanying spermicide gel. In my student days, I got both at my school’s Student Health Center, covered by the student health insurance fees that we were required to pay whether we used the student health center or remained on parental insurance.

I’ve written before about my bewilderment at the diaphragm’s disappearance, but I’m increasingly frustrated that the current political debates about the pill are contributing to the apparent erasure of all non-hormonal methods of birth control. The pill has become synonymous with birth control in some quarters, without consideration of the profound implications of that swap for women’s health.

I am not opposed to the pill, by the way. I want it to be available, I think it should be covered by health insurance, and I want it to be safe. But I also want women to have complete, accurate, accessible information about all of their birth control options. And let’s get all of them covered by health insurance.

Libido and the Pill

September 7th, 2010 by Laura Wershler
Laura Berman, Ph. D.

Laura Berman, Ph. D.

It’s great to see celebrity sexpert Laura Berman, Ph. D. – frequent Oprah TV guest, Oprah radio host, and (according to her website) world renowned sex and relationship expert - talk truth about the effect of the birth control pill on women’s libido.

In the September 2010 issue of Parenting magazine, Dr. Berman acknowledges that the pill can lower libido and clearly explains the mechanisms for this.  So far so good. What bothers me is her advice to moms experiencing this problem.

Happily, there are solutions, short of becoming celibate. Here are four options— talk to your doctor to see if any of them might be right for you.

Her recommendations include two alternative forms of hormonal contraception –  the Nuvaring and the Mirena IUD, the hormone-free IUD, and a sterilization method called Essure that scars the fallopian tubes to prevent sperm reaching egg.

Granted, all are legimate alternatives to the pill.  But the message sent, yet again, is that women who don’t want to get pregnant or remain celebate must depend on drugs, foreign objects inserted into the uterus, or sterilization.  If nothing else is mentioned, then nothing else must be trustworthy.

It has become all too typical for sexual healthcare providers to ignore the needs of women seeking information, support and services to use non-hormonal, non-invasive methods of birth control confidently and effectively.  This was a golden opportunity for Dr. Berman to talk about the ever effective condom, the new FemCap cervical barrier, and the growing interest amongst American women in Fertility Awareness Methods, which though wildly misunderstood by most in the medical and sexual health community have proven effectiveness equal to the pill.

Kudos to Laura Berman for telling the truth about the pill and libido.  Many sexual health care providers are not this open about the libido lowering effects of oral contraceptives.  Check out the comments at this May 2010 discussion at Jezebel.com about the subject.

Now I urge Berman to take on the challenge of providing information and support for women who are ready to turn the page on hormonal and invasive birth control methods.  For some women it will be the only way to achieve the better sex and intimacy at any age she promises on her website.



Ultrasound Man:Birth Control Superhero

May 17th, 2010 by Laura Wershler

superheroYou know how most superheros become superheros because of exposure to some weird, intensified chemical or element? Take Peter Parker’s spider bite for example.

According to a story reported in various media, including International Planned Parenthood Federation’s website, if science can perfect the contraceptive effect of ultasound on men’s testicles, then we may be in for a new breed of superhero.  Ultrasound Man: able to bear the burden of pregnancy prevention for women everywhere. 

I joke, but for decades women have yearned for gender equality when it comes to bearing the burden of birth control. Could the promise of six months of ultrasound induced, reversible infertility in men be the answer? Well, to date, we only know it works in rats. There is a long way to go before we send the men for a bi-annual ultrasound “zap test”.

This isn’t the first male method touted over the last decade. In 2003, news out of the UK about a birth control pill for men had women nodding their heads with approval. I was immediately dubious and dashed off a commentary for the Calgary Herald that began thus:

Memo to Big Pharma: Save your money. If you think the male birth control pill is going to be a big seller, think again. Memo to women everywhere: Curb your enthusiasm. If you think it’s time men took more responsibility, you’re right — but the Pill for Bill is not going to be it.

Because of the complex hormonal action of the pill for men, I knew it wouldn’t fly. As I noted in my piece:

According to a story from the London Telegraph, because the treatment is invasive, it is likely to be used only by men in long-term relationships. Read it and weep, gals, because this is the wicked truth. It’s OK for women of any age or relationship status to ingest birth control pills or receive the Depo-Provera injection that completely shuts down their reproductive systems, but men would never do the same. It is already postulated that only men in committed relationships are likely to submit to invasive hormonal contraception. That would be supportive husbands and partners of the best kind.

Although a recent  survey by the Family Planning Association found that one third of men would definitely use a birth control pill for men if it became available, I doubt very much, once the mechanism of action were explained (full disclosure), that there would be many takers. I suspect the side effects, and concerns about synthetic testosterone, would result in a pathetic compliance rate.

Certainly the ultrasound method sounds much less invasive. Research leader James Tsuruta of the University of North Carolina said: “We think this could provide men with reliable, low-cost, non-hormonal contraception from a single round of treatment.

Happily, “the team plans to investigate the mechanism that causes temporary infertility.” I think the guys would want to know how and why it works before signing up.  But they can rest assured because Dr. Tsuruta also said: “Establishing safety, efficacy and reversability: these are our top concerns.”

As media stories proliferate documenting the growing trend among young women to eschew the Pill (et. al) in favour of non-hormonal methods, news that there may be a safe, simple method for men on the horizon is both welcome and long overdue.

What I find hard to take, however, is this suggestion expressed by Allan Pacey from the University of Sheffield:

There is certainly a place for an effective non-hormonal contraceptive in men, but whether men would find it acceptable to have their testicles scanned regularly remains to be seen.

Find it acceptable? To have your testicles scanned regularly in a procedure described as “like sitting in a mini hot tub once every six months”?

I dare Mr. Pacey, a lecturer in andrology (the specialty that deals with men’s health) to say this in public to an audience of women who’ve been popping pills (et al) and inserting barrier contraceptives on both their and men’s behalf for the last several years. Ask these women if they find their current method of birth control acceptable. According to the Guttmacher Institute, 4 out of 10 women do NOT find their method of birth control satisfactory. But they take it or use it anyway, at least some of the time.

How to overcome resistance to Cycle-Stopping Contraception (a physician’s guide)

May 12th, 2010 by Chris Hitchcock

If you’re wondering why your doctor might not take you seriously when you question taking the pill to abolish your periods, you might want to look at this piece of advice.

I had a look at the Clinical Advisor magazine information – it looks like they pay for articles, help to massage them into shape, but as far as I can tell the articles are not peer-reviewed, and the editorial staff do not have any credentials after their names, so they look like non-medical people. But it is freely available on the web, and apparently gets sent to many practicing physicians and nurses. And it’s a lot more readable than other sources of medical education.

The article is framed as a doctor-to-doctor question:

What can I do to overcome patient resistance to continuous use of oral contraceptives (OCs)? So many women say it’s not natural.—SHERRY HILL, ARNP, Bothell, Wash.

And, the answer? Explain the physiology, explain that there is no build up of old blood, that menstrual flow doesn’t have any effect on infections or toxins. And, for talking points, use the educational materials about cycle-stopping contraceptives on the Association of Reproductive Health Professionals web page (coincidentally funded with unrestricted educational funds from companies who happen to make cycle-stopping contraceptive products). And use Malcolm Gladwell’s 2000 article, John Rock’s Error, to reframe monthly menstrual flow as a historic anomaly (“you don’t need that old-fashioned thing”) and help women to see their regular menstrual flow as unnatural, so that the synthetic drugs you are suggesting will seem less unnatural by comparison.

But, ultimately, “if a patient feels that a monthly withdrawal bleed suits her best, many OCs containing 21 active pills and seven inert pills are available.”

I guess the option of using non-hormonal contraception just won’t come up.

Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.