drospirenone Archives - Hormones Matter

Pill Bleeds Are Not Periods

Published on June 3, 2015

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The Pill is not just contraception anymore. It has become standard treatment for everything from acne to endometriosis to irregular periods. Yes, hormonal birth control can mask symptoms, but it cannot “regulate” hormones or periods in any meaningful way.

Hormonal birth control does not augment or regulate hormones. Instead, it suppresses ovarian function and shuts down hormones completely. It replaces endogenous hormones with synthetic steroids, and that’s not good enough for women’s health. Real hormones have many benefits for health that synthetic steroids simply cannot deliver.

Real Hormones versus Synthetic Hormones

Our real endogenous hormones are estradiol and progesterone. In contrast, synthetic steroids are ethinylestradiol, levonorgestrel, drospirenone, and many others. Real hormones and synthetic steroids are similar molecules, but they’re not identical and as a consequence, synthetic steroid have many different effects on the body, some of which we are only now beginning to understand.

For example, estradiol improves insulin sensitivity. Its synthetic counterpart ethinylestradiol impairs insulin sensitivity [1] (which is one of the ways the Pill causes weight gain). Progesterone is beneficial for hair, brain health, and bone density, but its synthetic analogues levonorgestrel, drospirenone, and medroxyprogesterone have quite different effects. They cause hair loss, depression [2], and reduced bone density. Moreover, the drospirenone progestin found in the Yaz, Yasmin and Ocella series of birth control pills, increases the risk of heart attack and stroke six fold. Its modified shape blocks what are called the mineralocorticoid receptors. These receptors are responsible for salt and water balance (think swelling) and blood pressure.

The only way that ethinylestradiol and progestins are similar to real hormones is that they induce a uterine bleed. They can even induce it monthly, but only if they’re dispensed that way.

Why Bleed?

Who really cares about a bleed for its own sake? If women can’t have real hormones, then why have a monthly bleed at all? It is merely to give the appearance of a period, and reassure women that they’ve had a period (when they haven’t). A bleed does prevent excess build-up of the uterine lining, but it does not have to be monthly. It can be quarterly or yearly or any time we withdraw from the synthetic steroids. Regardless of when we choose to bleed, the pill bleed is not the same as menstruation. Remember, the purpose of oral contraceptives is to block ovulation and prevent pregnancy. Without ovulation, our bodies do not produce endogenous hormones. Indeed, as any woman who has gone off of the pill after a long period of usage will tell you, it takes some time for ovulation and hormone production to begin again.

Normalizing our Periods: A Myth

Interestingly, the “regulation” of periods was the Pill’s earliest cover story. When the Pill was first developed, it could not be sold as contraception because contraception was not legal. Instead, the Pill was ostensibly prescribed to “normalize” periods. “Normalize” was a quaint euphemism which really just meant to be “not pregnant” (wink-wink).

Five decades later, and the Pill’s early cover story has now taken hold as a kind of weird counterfeit reality. Doctors readily prescribe oral contraceptives for all manner of female reproductive disorders, the most common of which is to ‘normalize’ the menstrual cycle. What they, and most women, fail to realize is that the monthly bleed precipitated by the withdrawal of synthetic steroids, is not a real period. It is simply a withdrawal bleed.

It’s time to end it. It’s time to bring back real periods.

There Is Another Way

As a naturopathic doctor working in women’s health for twenty years, I want my patients to have real periods. More precisely, I want them to have a follicular phase and make estradiol. I want them to ovulate, so they can then have a luteal phase and make progesterone. In short, I want my patients to make real hormones and to enjoy their many benefits.

There’s another reason I want my patients to have real periods. A healthy, regular period tells me that all is well with her underlying health. If a woman does not have healthy periods, then I keep working with her until she does. We use her period as a helpful, useful marker guiding her health decisions. We think of it as her monthly report card.

It’s not always easy to restore healthy periods, but it can be done. But with a little perseverance, natural treatments such as diet, supplement and herbs work well, and they give women what they deserve: A real period rather than a pharmaceutically induced bleed.

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.

References

Kojima T et al. Insulin sensitivity is decreased in normal women by doses of ethinyl estradiol used in oral contraceptives. Am J Obstet Gynecol. 1993 Dec;169(6):1540-4. PMID: 8267059
Kulkarni J et al. Depression associated with combined oral contraceptives–a pilot study. Aust Fam Physician. 2005 Nov;34(11):990. PMID: 16299641

The High Cost of Bad Birth Control: Yasmin and Yaz Lawsuit News

by Chandler Marrs, PhD

Published on December 17, 2012

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As the debate over birth control rages, an often ignored aspect of the debate is safety. Some feminist groups contend that we can’t talk about the dangers of certain oral contraceptives or other hormonal birth control methods lest we give ammunition to the anti-birth control crowd.

“If you’ve seen on TV somebody crying that their daughter died taking birth control pills, and you’re a mom, you may not remember the (particular) birth control pill,” said Diana Zuckerman, president of the National Research Center for Women & Families. “You’ll just say you can’t be on it to your daughter.”

That sentiment couldn’t be more wrongheaded. Of course, we should be talking about the safety of birth control. Indeed, we should shouting at the top of our lungs about the dangers of some oral contraceptives and many medications in general. What good is it to have access to birth control, only to be killed or chronically injured from those pills? Death and grievous injury would seem to defeat the purpose of the entire reproductive rights movement.

We Need Safer Birth Control Options

As we’ve reported previously Yasmin, Yaz and other drospirenone based oral contraceptives (generics Syeda, Ocella, Zarah, Loryna,Gianvi, Safyral and Beyaz) appear decidedly unsafe. No amount of marketing will overcome the safety issues.

As of April, there were over 11,000 lawsuits pending with 14,000 plaintiffs. By October of this year, Bayer, the makers of the Yasmin line of birth control, has agreed to pay $750 million to settle the first 3400 lawsuits. With only 7600 more lawsuits to go, this might be one of the most expensive drugs to date.

The Dangers of Drospirenone

Several large studies (here, here, here) have found that women taking drospirenone based oral contraceptives have a two- to threefold increase in deep vein thrombosis and pulmonary embolism compared to other contraceptives. Bayer contests those results with several company sponsored studies that indicate no such risk. Recent reports of withholding data, question Bayer’s assertions.

AdverseEvents.com, a website that tracks all medication side-effects both from FDA and patient reporting, shows that the Yasmin line of oral contraceptives carry with them a range of very serious side effects, including death.

Yasmin, Yaz and Pulmonary Embolism

Notice the number and percentage of deaths, life threatening conditions and hospitalizations compared to other potent and in some cases, already recalled medications.

Yasmin, Yaz and Deep Vein Thrombosis

Why are These Products Still on the Market?

Money.

The Yasmin line of birth control is one of Bayer’s most lucrative product lines with over 4 million women taking these pills monthly. Even with the negative publicity surrounding for these products, revenue for the Yasmin line of products neared 1.1 billion for the first nine months of 2012. After 11 years on the market, total revenue for these products was likely well over $10 billion. If the company pays out $1-2 billion in claims, but makes $10-15 billion, the cost-benefit ratio is skewed in favor of maintaining their market presence. The fines become just another cost of doing business.

What about the FDA?

The FDA relies heavily on some 50 advisory committees to review drug safety. Many of these experts have strong ties to industry. Reports of conflicts of interest abound. In the case of drospirenone, early reports are claiming the decision making was indeed skewed by industry sponsored experts.

At least four and possibly six experts on the panel convened to review the dangers of drosperinone, had financial ties to Bayer. Subsequently, efforts to remove the Yasmin products from the market failed by four votes: 15-11. Instead the panel voted to increase warnings on the labels of these drugs.

Worse yet, unsealed court documents from lawsuits in Illinois indicate the possibility that Bayer knew of the increased dangers associated with the Yasmin products, as early as 2004 and withheld (and continues to withhold) that data from the FDA. According to reporters at Pharmalot and a report by David Kessler, a former FDA commissioner and current advocate for many of the legal cases:

“For instance, in a draft of the August 2004 white paper, Bayer employees wrote: “Compared to the three other (oral contraceptives), Yasmin has a several fold increase in the reporting rates for (deep vein thrombosis), (pulmonary embolism) and confirmed VTEs…When considering only serious AEs, the reporting rate for Yasmin was 10 fold higher than that with the other products which were very similar in magnitude.” Bayer employees argued in a revised draft that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin and other OC users.”

Who to Trust

It is no longer reasonable for patients to blindly assume an FDA approved medication is safe or right for us (Vioxx, for example). Even research in major medical journals is suspect, with publication bias and outright fraud. Medical decision making is not for the faint of heart.

Luckily data are available online and though still convoluted, there is a degree of information availability never before possible. If you look, you can find the information needed to make a decision on almost any medication. We like and trust the data from Adverse Events. Their sole purpose is to expose and make accessible to the public the risks associated with medication.

Moving Forward

Demand better. We’ve long since moved away from the age of innocence where medications are concerned. Before deciding on the appropriate birth control method for you or your daughter, do the research, ask the questions and make an informed decision.

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