by Leontine Bakermans MSc PharmDCoordinator One of Us, Netherlands
The birth control pill came on the market in the middle of the last century as a new remedy for menstrual disorders, such as painful or irregular periods, and it is still prescribed for these indications, usually for a short time. But what was first described as a side effect ("you can become infertile") quickly became the main indication.
The pill is now used by millions of women around the world. In the field of family planning, the pill is also presented as the instrument par excellence for the emancipation of women. Its use is promoted at all levels, such as the proposal of the Council of Europe with the resolution 'Strengthening women: promoting access to contraception in Europe' (1) and the UN population fund (UNFPA) (2).
However, there seems to be a turnaround, the number of women taking the pill is decreasing. This is because there are also negative sides of pill use, about which more and more is known.
There are different types of oral contraceptive pills. The most commonly used pills are the so-called combination pills and the pill with progestogen only, or the mini pill. This article is limited to the combination pill, which is most commonly used. At the end the morning-after pill and abortion pill will be discussed. The combination pill contains two artificial sex hormones: an estrogen and a progestogen. The pills can be further distinguished into so-called 2nd and 3rd generation pills. The 2nd generation pills contain levonorgestrel and norgestimate as progestogen and the 3rd generation pills contain e.g desogestrel. The estrogen is almost always ethinylestradiol.
The pill is swallowed for 21 days, after which nothing or seven placebo pills are taken for seven days During these seven days, what is called a “withdrawal bleed” occurs; it is not a real period. Because of these monthly hemorrhages, it seems as if there is a normal cycle, but this is a fake cycle.
What happens during a normal cycle is summarized in the figure below:
The sex hormones oestradiol and progesterone are regulated from the brain (hypothalamus and pituitary) and via the ovaries:
Because of this:
The effect of the pill is based on the same principles as the hormones in the normal cycle, but in the opposite direction (5). The artificial hormones in the pill weaken the signal given by the brain and this stops the natural cycle. The body itself no longer produces natural estradiol and progesterone, with the result that
To reduce side effects, the dosage of estrogens and progestogens in the pill has been reduced. The decreasing dosage of the pill has a direct effect on the effectivity and of course, a minimal amount of active ingredient is needed for a drug to have an effect. As a result, the main effect may no longer be 100% and egg ripening and ovulation are not always stopped. An egg can then still be released that could be fertilized. If this fertilized egg is implanted in the uterus despite the fact that the pill makes implantation more difficult, we have an ongoing pregnancy, despite taking the pill. But it is also possible that the fertilized egg cannot implant in the uterus, because the pill has not made the uterine mucosa suitable for it. The fertilized egg is then destroyed and the pill works as an abortifacient.
In practice there are a number of factors that reduce the efficacy of the pill. There are situations in which too little of the active substance from the tablet becomes available in the body, for example due to certain interactions with other medicines or diarrhea, or because a number of women have difficulty taking the pill consequently every day. Certain genes may also cause increased degradation. How often does an early abortion occur? There are no exact numbers, we can only say that it cannot be excluded that it happens (6,7).
Because research shows that some types of cancer depend on naturally occurring hormones for their development and growth, a lot of research has been done into the relationship between hormones in the pill and cancer. A study showed that taking the pill for more than 8 years showed an increased risk of cancer (8). By the way, the pill has a protective effect against cancer of the lining of the uterus and ovaries, but these types of cancer are very rare by nature and an improvement of a very small amount is still very small. The U.S. government has therefore added estrogens contained in the pill to the official list of carcinogens (9) and the WHO has also classified the pill as a group 1 (the heaviest type) carcinogen for breast, cervical and liver cancer (10). This is the same category as for tobacco and asbestos.
The risk for a woman to get breast cancer depends on several factors, including a link with pill use, because estrogens affect breast tissue. The risk increases from 1.1 times higher with 1 year of pill use to 1.6 times higher with 10 years of use. Further, this risk is higher if you start taking the pill at a young age, because when breast cell proliferative activity is high, there is more chance for mutations in DNA, so the susceptibility to genetic damage in breast epithelial cells becomes higher. Women who have an abnormality in one of the breast cancer genes even have a greatly increased risk of developing breast cancer (11,12,13).
The pill plays a key role in the development of liver cell adenoma (benign tumor), usually after use for more than 5 years, but sometimes an adenoma develops as early as after 6 months of pill use. It occurs in about 3 out of every 100,000 pill users (15, 16).
Cervical cancer is the second most common type of cancer in females worldwide.
Human papillomavirus (HPV) is a group of viruses that are extremely common. Two HPV types (16 and 18) cause 70% of cervical cancers and pre-cancerous cervical lesions. HPV is mainly transmitted through sexual contact and most people are infected with HPV shortly after the onset of sexual activity. A condom gives insufficient protection because the virus is available in a broad zone around the sex organs. OC users might have more sex, with more partners higher chance of infection. Changes to cervical fluid caused by OC use may compromise one’s immunity higher susceptibility to HPV infection.
Women who take the pill for more than 5 years are twice likely to get cervical cancer. After 10 years, this can increase to a 3 times higher risk (17,18).
The amount of bone tissue in skeleton is known as bone mass and can keep growing until age 30. At that point, bones have reached their maximum strength known as peak bone mass (PBM). The PBM relates to lifetime fracture risk. Natural estrogen, plays an essential role in bone growth. By suppressing estrogen, as in OC-use, there is
a detrimental effect on the bone. In later life it increases the risk of brittle bones (osteoporosis) and therefore a rise in bone fractures (19).
Heart and blood vessels
Oral contraceptive hormones have an impact on the lipid and carbohydrate metabolism. They significantly affect plasma lipoprotein metabolism, which can raise the levels of plasma triglycerides, low-density lipoprotein, and high-density lipoprotein.
Taking the pill therefore increases the risk of thrombosis (the formation of a blood clot,
in a vein of the legs, lungs, heart (heart attack) or brain (stroke) 2 to 4 times (23, 24). The third-generation pills even give a 4 to 7 times higher risk of thrombosis (reason why they are now much less prescribed).
Studies show that in young women taking the contraceptive pill more or less doubles the risk of having a stroke (20.21). Women who take both the pill and carry the variant of a certain coagulation factor gene are 20 times more likely to have a brain attack (22).
In rare cases, a venous thrombosis or pulmonary embolism is fatal (26).
The risk of thrombosis when taking the pill is also greatly increased by the presence of risk factors such as smoking, age and obesity.
In addition to effects on the ovaries, the sex hormones also influence emotional things like attraction, stress, hunger, behaviour, friendships, aggression and how you feel (4). Effects on this by suppressing the sex hormones through pill use is therefore inevitable, but only recently more clarity has become available. It appears that also the Hypothalamic-Pituitary-Adrenal axis (HPA axis) is involved. This axis also acts via the hypothalamus and pituitary gland, but with the adrenal glands as target organ. Via this axis, the renal glands release cortisol. Cortisol reacts to stress and regulates many body processes including, mood, emotions and sexuality. Sex steroids exert profound control over the HPA axis. Suppressing this system with artificial hormones, has an effect upon all the processes this axis regulates. The HPA axis continues to develop until after puberty.
A 2016 Danish study of women between the ages of 15 and 34 showed that among those who used hormonal contraceptives, there was a forty percent higher risk of taking antidepressants. Especially women between 15 and 19 years had a higher risk of becoming depressed (28).
A link between pill use in young women and the risk of depression in adulthood has also been shown. This suggests that adolescence can be a sensitive period during which pill use can increase a woman's risk of depression, even years after use of the pill was stopped (29).
The Dutch researcher Estrella Montoya states: "It is almost certain that the pill has an effect on the brain, in areas that are important for mood, anxiety and pleasure (30).
In her book 'Your brain on the pill' (4), Sarah Hill, professor of psychology, describes new research on the effect on the brain and psychological influence of pill use. She came to the conclusion that by suppressing the natural hormone profile through pill use you can start to feel like a totally different person. This goes as far that, although the research is still in its very recent, this suggests that the pill could have an influence on who you find attractive (through pill use you could fall for a different type of man as without pill), on the dynamics of your relationships (pill extinguishes feelings of lust), how you react to the face of your partner, on your chances of ever getting divorced, etc.
MRI scans have recently shown that the size of certain parts of the brain, including the hypothalamus, was considerably smaller in women taking the pill than in women not taking it (31). And the hypothalamus is the organ from which the hormones are controlled. What effect this has in the longer term is still unknown.
The influence of sex hormones plays an enormous role in all gender-specific developments during puberty and adolescence, not only in the visible parts of the body, but also on the brain. Girls who are just menstruating are still busy with their brain development. Brain development is usually not finished until we are 20-25 years old. Sarah Hill advises against influencing your hormone balance with the pill before the age of nineteen or twenty and recommends more scientific research into the effects of the pill. Animal studies have found that hormones, especially when the brain is still developing, can irreversibly influence behavior. Adolescent girls have in addition a higher chance of getting breast cancer and reach a lower peak bone density with higher risk of fractures.
There are 2 types of morning-after pill available. One consists of the same progestogen as most commonly used in the pill: levonorgestrel. It can be taken up to 72 hours after unprotected sexual intercourse. Later, another one is added EllaOne® (ulipristal acetate). This is even effective up to 120 hours (5 days) after unprotected sexual intercourse. They are sold about 300,000 times a year in the Netherlands in a population of 17 million people (32).
The effect of the morning-after pill is partly based on ovulation inhibition, but if the pill is taken from the day before ovulation, i.e. in the most fertile period, ovulation can no longer be inhibited. If ovulation has already occurred, it can of course no longer be inhibited as well. In these cases, the efficacy is based on preventing implantation, an abortifacient effect (33).
Despite contraception, many women get unplanned pregnancies. 60-70% of women who come for an abortion indicate that the unwanted pregnancy occurred despite the use of contraception (34).
The abortion pill is a series of 2 types of pills, to be taken 2 days in a row. The first pill to be taken, mifepristone, is an antiprogesterone drug, which suppresses the natural progesterone needed to maintain a pregnancy. It loosens the baby. After 2 days another medicine has to be taken, prostaglandin, which causes the uterus to contract and expels the baby. This can be done up to ten weeks after the last menstruation in the U.S.
The abortion pill is not a simple and innocent remedy. It ends human life and it's not without risk. The leaflet therefore states that it is important to have access to appropriate medical care if an emergency situation arises and the patient must remain close to the treatment center (36). In addition, an ectopic pregnancy must first be excluded, because in that case the abortion pill does not work and medical intervention is required. Enormous cramps and heavy blood loss are common. Prolonged vaginal bleeding may occur. In some cases, severe bleeding may require surgical removal of the uterus. Rarely, the uterus may rupture or a fatal shock syndrome may result from a particular bacterium. Bleeding is in no way proof that the pregnancy has ended, because bleeding also usually occurs if the treatment fails. The non-negligible risk of failure (4.5 to 7.8% of cases) makes a control visit mandatory to check that the abortion has been completed. In case of an incomplete abortion, a curettage is still required to achieve complete abortion. A so-called "do it yourself abortion", which means that the pills are taken without medical supervision, can therefore have terrible consequences.
What if there is regret after the abortion pill? After taking the abortion pill, some women have regret and realize that they do want to keep their baby. If they have only taken the first pill, but have not yet started the medication for the following days, they are still eligible for the abortion pill reversal.
The abortion pill reversal consists of the drug progesterone because the woman’s body had stopped producing it naturally when the first abortion pill was taken.This was switched off by taking the first pill of the abortion pill. By not taking the second day's pills and taking the abortion pill stopper as soon as possible (at least within 72 hours) and continuing this until the 14th week of pregnancy, the baby can be saved up to 65% of cases (37).
We are concerned about artificial sex hormones that men use in the gym because of all the effects they have on their bodies. But at the same time, healthy women are routinely prescribed female sex hormones and swallow them for years, despite the increased risk of cancer and thrombosis, sometimes with fatalities and severe emotional disturbances.
The hormones in the pill are excreted again and reach the water purification system via the sewer. The sewage treatment system does not succeed in breaking down all the female hormones in the wastewater, causing estrogens to re-enter the environment. Synthetic hormones can be active even at very low concentrations. Estrogens from the pill, for example, are ten times more active than the natural female estrogen (38). Hormone-disrupting effects in the aquatic environment have been clearly and frequently demonstrated. For example, feminization was found to occur in male fish.
What this means for humans and the environment is still unknown (39-43).
There is an alternative to taking the pill. This alternative requires the cooperation of both partners, especially in the field of self-control, but it has no side effects: natural fertility management, also called 'Natural Family Planning' (NFP). NFP is based on the knowledge that, on the one hand, sperm cells only survive in the fallopian tubes for a maximum of five days and, on the other hand, an egg cell can only be fertilized for a few hours. A woman is therefore fertile for a week before ovulation until about a day after it. If one does not have intercourse during this period, pregnancy is impossible. To determine when the fertile period falls, there are several possibilities.
The Billings method makes use of the fact that around ovulation the mucus in the cervix is thinner. It is possible to draw 'threads' from it, as with the white of a raw egg. This is easy to determine yourself. You can even determine when a woman becomes fertile again after a pregnancy.
The sympto-thermal method, such as Sensiplan, is also based on the observations in the cervix mucus, but also uses the woman's body temperature: after ovulation the body temperature rises by about half a degree (five dashes). By taking the temperature daily, one has an extra control on ovulation.
Information about Sensiplan: www.sensiplan.nl
© One of Us Nederland
by Susan Dammann, RN, LAS, Medical Specialist
Does your center provide information about the possible side effects and risks of various birth control methods? If so, you may want to consider including the following information in your materials.
A Jan. 22 article published in Medscape News on January 22, 2015 discussed a study done in Denmark which found an association between hormonal contraceptives and an increased risk for glioma in younger women. The results were published in the print edition of the British Journal of Clinical Pharmacology. The reported risk increases with the duration of use, the study showed. "A nearly two-fold increased risk of glioma [a common type of primary brain tumor] was observed among long-term users of hormonal contraceptives."
The researchers highlight the fact that progesterone exposure was associated with the highest increased risk for glioma in their study. While the study had many strengths, its weaknesses are being identified, but are not expected to alter the results significantly.
"Oral contraceptives are known to influence the risk for certain cancers, but few studies have examined any link to central nervous system tumors", said David Gaist, MD, from Odense University Hospital and the University of South Denmark. He added that although the findings of this study must be interpreted with care, "We feel it is an important contribution and we hope that our findings will spark further research on the relationship between female hormonal agents and glioma risk."
by Marilyn Henderson, RN Freda M. Bush, MD
A recently released policy statement by the American Academy of Pediatrics encourages Pediatricians to counsel adolescent patients regarding contraception in order of effectiveness. The most effective contraception is the progestin implant and the second most effective device is the intrauterine device, or IUD. Historically, IUDs were not used in nulliparous women (those who had not previously given birth), nor in women outside of a monogamous relationship. The uterine cavity is usually larger in women who have already carried a pregnancy and it was believed that a smaller uterine cavity would not tolerate a foreign object well, expelling the IUD and increasing the risk of pregnancy. The concern for women who were not monogamous was the increased risk for sexually transmitted infections that could develop into pelvic inflammatory disease.
Additionally, patients who believe that life begins with conception, need to be counseled that although the chemicals included with the IUD (copper or progestin) are designed to inhibit sperm from reaching an egg, IUDs also affect the lining of the uterus, making it undesirable for implantation, if conception does occur.1,2 In addressing the concern of conception occurring with an IUD in place, the Technical Report of the Academy of Pediatrics simply skirts the issue like this:
"The primary mechanism of action of both types of IUD is preventing fertilization by inhibiting sperm motility. The levonorgestrel IUDs also thicken cervical mucus. All mechanisms occur before implantation, when pregnancy begins, and inhibiting implantation is not believed to be a primary mechanism of action for either type of IUD."3
The report does not leave room for personal opinions and beliefs about when pregnancy begins, but simply states that pregnancy begins with implantation. Since the copper IUD, Paragard, is approved for use as an emergency contraception, there is even more concern for those who view the IUD as an abortive method of birth control. Paragard is reported to be 99% effective in preventing pregnancy,4 if inserted up to five days following unprotected intercourse.3 Medical Institute's greatest concern for IUD use in teens is sexually transmitted infections, which can lead to pelvic inflammatory disease and infertility (the inability to achieve pregnancy when desired). This concern is addressed in most of the current literature, but is not seen as a contraindication for IUD use. Interestingly, the CDC's fact sheet on PID6 lists the following risk factors for PID:
Just being a sexually active teen is a risk factor for PID. When the IUD is inserted, a second risk factor is added. Another CDC Fact Sheet, "Sexually Transmitted Infections Among Young Americans", points out that "many young people have multiple sex partners", indicating that risk factors numbers 2 and 3 for PID might also be a concern. And finally, the Fact Sheet mentions that many infected teens are often unaware that they have an STI and have not had the proper screening for Chlamydia, indicating risk factor number 1. With five out of seven risk factors for PID specifically being a concern among teens, one must wonder about any recommendation for IUD use in youth.
The American Academy of Pediatrics Technical Report continues the mixed message with statements like this: "...past associations between infertility and IUD use among nulliparous women were attributable to STIs rather than IUDs"3(page e1262) and the CDC Practice Recommendations states, "Although women with STDs at the time of IUD insertion have a higher risk for PID, the overall rate of PID among all IUD users is low."5
The answer to the problem of STIs from both the CDC and the Academy of Pediatrics is condoms. Both organizations recommend that all patients be counseled on the use of condoms, regardless of their choice of contraception to help prevent STIs. However, in 2013, only 8.8% of sexually active high school students reported using condoms along with another method of birth control8, perhaps indicating that with the fear of pregnancy gone, there is little motivation to use condoms.
Fifty percent of all new cases of STIs occur in young Americans from 15–24 years of age. Ignoring the increased risk for PID and resulting infertility for the sake of preventing teen pregnancy is not in the best interest of our youth. Therefore, MI does not agree with the recommendation for IUD placement in adolescent girls.
1). "ParaGard T380A Intrauterine Copper Contraceptive", Rev 6/2013, ParaGard – FDA prescribing information, side effects and uses, Retrieved Oct 2014 from Drugs.com, http://www.drugs.com/pro/paragard.html 2). Skyla (levonorgestrel-releasing intrauterine system, full prescribing information, Retrieved from website Oct. 2014, www.skyla-us.com 3). Ott Mary, et al, Committee on Adolescents, "Contraception for Adolescents: Technical Report," Pediatrics: Official Journal of the American Academy of Pediatrics, 2014;134;el257; originally published online September 29, 2014; DOI: 10.1542/peds.2014-2300. Retrieved Oct. 2014. (quote: p. e1262)4). Belden P & Harper C, "The Copper IUD for Emergency Contraception, a Neglected Option," (Editorial), Contraception 85(2012) 338-339 5). CDC, "U.S. Selected Practice Recommendations for Contraceptive Use, 2013: Adapted from the World Health Organization Selected Practice Recommendations for Contraceptive Use, 2nd Edition," prepared by: Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Morbidity and Mortality Weekly Report, Recommendations and Reports/Vol.62/No.5, June 21, 2013. (quote: p. 10) 6). CDC, "Pelvic Inflammatory Disease (PID) – CDC Fact Sheet", Retrieved Oct 2014 at http://www.cdc.gov/std/pid/stdfact-pid.htm 7). CDC, "Sexually Transmitted Infections Among Young Americans", July 2014. Retrieved Oct 2014 from http://www.cdc.gov/nchhstp/newsroom/2013/SAM-Infographic-2013.html?s_cid=nchhstp-nr-sam-008 8). CDC, "Youth Risk Behavior Surveillance – United States, 2013," Morbidity and Mortality Weekly Report, June 13, 2014, Surveillance Summaries/Vol.63/No.
Reprinted with permission from the Medical Institute for Sexual Health: Marilyn Henderson, RN (1st Author listed) and Freda M. Bush, MD (2nd Author listed).
Because we can - should we? A wise society asks that question of every new technology. That is the question the Weld County commissioners have chosen to grapple with in their decision not to fund emergency contraception in county health clinics.
After intercourse, sperm can unite with an egg in the fallopian tube within hours. If that union occurs, an amazing process then begins by which chromosomes from the father and mother are joined together and a new cell is formed. This living cell contains its own complete set of chromosomes different from father or mother. These will determine gender, eye color, temperament and all the many characteristics that will make this individual unique. This is not a potential human being - it is a human being with potential. This is exactly what a young human is supposed to look like on its first day of life. Now, this cell divides and multiplies and begins a six day journey which will end in nestling into the wall of its mother's womb. Here this new life will grow for 9 months until it is time to make its next journey - birth.
Emergency contraception works by blocking the surge of hormones which stimulate ovulation (the extrusion of an egg from the woman's ovary). If ovulation is prevented, pregnancy can be avoided. What is less clear, however, is what happens if the medication is taken after that hormone surge or after ovulation has already occurred. Scientists have come to differing conclusions about this and serious moral concerns have been raised about whether, in some cases, emergency contraception might lead to the loss of a fertilized egg - a life. This moral concern lies at the heart of the Weld commissioners' considerations.
The idea of emergency contraception leads us to look at a much larger and more important issue. The nature of the sexual act is twofold: 1) to form a bond that will help unite a husband and wife together and 2) to beget life. The bond helps create the stable environment so necessary to welcome new life. When modern society embraced the technology of contraception, the sexual act was redefined in a radical and fundamental way. This technology designed to prevent pregnancy allowed for sex without consequences - no babies, no commitment. This redefinition of the sexual act has produced far reaching and painful effects in our culture.
Sex without consequences demands the availability of abortion. The emergence of "the pill" in the 1960's led to a call for the legalization of abortion within a decade. January 22nd marked the fortieth anniversary of Roe vs. Wade. In those 40 years, over 50,000,000 abortions have been performed in America.
For nearly 250 years in our country, until slavery was abolished by the 13th Amendment, it was legal for a white man to own a black man - legal, but not moral. The black man was seen as sub-human or not human at all. We look back at those times and wonder how their thinking ever could have been so misguided. A future generation will look back on this era and wonder the same thing about us.
For such a future time to come to pass it will require something far more difficult than the overturning of legalized abortion - it will require a change of the human heart. It will mean recapturing the true meaning of sexual intimacy and restoring it to its proper place within marriage alone. So difficult - but the possibility awakens in us great hope.
By Julie Lynch McDonald, Pharm.D. • Craig, Alaska
Despite the abundant availability of sterilization procedures, male and female condoms, spermicides in the form of gels, creams, foams, and films, sponges, cervical caps,diaphragms, copper and hormonal IUDs, a plethora of hormonal contraceptive drug combinations available as tablets, patches, vaginal rings, implants, and injections, and three approved “emergency contraception” tablets, half of all pregnancies in the United States are still unplanned.
What is the solution? According to the Population Council, it is another contraceptive drug regimen.
This commentary is written to briefly evaluate an article titled, “Vaginal ring delivery of selective progesterone receptor modulators for contraception,” written by Dr. Jeffery T. Jensen of Oregon Health and Science University and published in Contraception1. To provide some background, research is being conducted on the use of a drug called ulipristal—the active agent in ella®—through a ring inserted vaginally to prevent pregnancy by inhibiting ovulation.
This research is being conducted by the Population Council, which was founded in 1952 with the stated mission of helping “achieve a humane, equitable, sustainable balance between people and resources.”
Ulipristal belongs to a group of drugs called Selective Progesterone Receptor Modulators (SPRMs). The first SPRM approved for use in the United States was mifepristone, which is commonly known as “the abortion pill.” Mifepristone is effective at terminating implanted, growing pregnancies due to its ability to block progesterone, an essential hormone for pregnancy. Blocking of progesterone by mifepristone results in fetal detachment from the placenta, which is followed by vaginal expulsion of the fetus.
SPRMs such as ulipristal and mifepristone can both suppress ovulation as well as terminate implanted pregnancies. The manner in which they act depends primary on the timing of administration (when it is taken within a woman’s cycle), and potentially the serum concentration (amount of drug in the body).
Upon review of Dr. Jensen’s article, there are two primary concerns. First, women will be given a drug marketed to prevent contraception that also possesses an established capability to terminate implanted pregnancies. Second, SPRMs such as ulipristal have questionable safety for women, especially with long-term use. Both concerns will be briefly discussed in the following paragraphs under the topic headings, “Risk to Pregnancies,” and, “Risk to Women.”
Dr. Jensen’s article stated that 32% of test patients (25 out of 78 women) still ovulated despite the use of ulipristal vaginal rings. There was no discussion on if pregnancies occurred in the 25 women who ovulated, nor was there a description of the outcomes for these pregnancies if any did occur. The future goal was identified to be a tripling of the dose of ulipristal given to women in order to decrease the percent of women who ovulate to 10%, but this is still a high percentage of women who may become pregnant, especially given the following: Ulipristal is proposed to be given on a daily basis via a vaginal ring inserted for three months. Women who do achieve pregnancy despite use of ulipristal, then, will expose their embryo/fetus for two months to a drug known to be “embryotoxic at low doses.”2
Furthermore, since the absence of menstruation is typical in women using ulipristal vaginal rings, women could be unaware of their pregnancy for months. Therefore, beyond the fetal risk from direct daily exposure to ulipristal, the fetus could also be exposed to risky behavior (including drug and alcohol use), and denied standard prenatal care simply because the mother is unaware of her pregnancy.
None of these concerns were addressed in the article.
There are two key risks to women posed by use of SPRMs. The first risk is infection, which is increased due to a suppressed immune system and the potential for a deceased fetus, which would serve as a medium for bacterial growth prior to its vaginal expulsion. The second risk is related to changes in the lining of the endometrium, or wall of a woman’s womb.
SPRMs are well-documented to produce antiglucocorticoid effect, which means they suppress the immune system. The Department of Health and Human Services’ Emerging Clostridial Disease Workshop found that mifepristone’s effect on the immune system resulted in the “clinical findings of rapid fulminating lethal shock syndrome” that was neither preventable nor treatable.3 It is established that ulipristal has a “high affinity” for progesterone and glucocorticoid receptors. The concern for ulipristal to have antiglucocorticoid effects was mentioned in the article, but no evaluation of this concern was provided.
Dr. Jensen’s article stated SPRM-associated endometrial effects “were frequently observed,” and were reported in 41% of women using the ulipristal ring. Since the endometrial effects such as endometrial hyperplasia or cancer are dose-dependent, it is reasonable to assume higher concentrations of ulipristal will result in a higher incidence of this adverse effect. Therefore, in the future it can be expected to have a greater risk when the dose is tripled in an effort to increase the percentage of women who will not ovulate. According to the article, a six-month study is being conducted to evaluate the long-term safety of using ulipristal vaginal rings, but this timeframe is unrealistically short.
In conclusion, development of SPRMs has been highly controversial due to their innate ability to terminate implanted pregnancies and the risks they pose to women. Nonetheless, SPRMs have been rushed through the FDA approval process under the subpart H, which is a fast-track reserved for “new drugs to treat serious or life-threatening diseases.”4
The push to develop ulipristal as “contraception” is being completed without evident concern for fetal effects and in an apparent absence of appropriate communication to patients about ulipristal’s ability to terminate implanted pregnancies.
Concern for the risk to women due to ulipristal appears to be secondary to the priority placed on preventing unplanned pregnancies. While a goal of reducing unplanned pregnancies is commendable, realistically, unplanned pregnancies will never be completely eliminated—and maybe they shouldn’t be. When did unplanned pregnancies become equivalent to horrific diseases like cancer or the plague that would be worthy of risking women’s health and exposing fetuses to toxic agents?
As a pharmacist and a woman, I hope the scientific community can begin to take a more proactive approach to solving unplanned pregnancies, rather than continually pushing for chemical solutions that pose an often under-reported and under-studied risk to women and their fetuses.
1. Jeffrey T. Jensen , “Vaginal ring delivery of selective progesterone receptor modulators for contraception,” Contraception 86 (2012), http://www.contraceptionjournal.org/article/S0010-7824%2812%2900804-9/abstract (accessed March 11, 2013).
2. European Medicines Agency. CHMP Assessment Report for EllaOne. Document reference EMEA/261787/2009.
3. Department of Health and Human Services. Emerging Clostridial Disease Workshop. Summary of Proceedings. May 2006.
4. Code of Federal Regulations. Title 21, Chapter 1, Part 314, Subpart H, “Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses,” Sec. 314.500.
By Amy Scheuring, Executive Director, Women’s Choice Network
The recent barrage of news coverage following Susan B. Komen for the Cure’s proposed defunding of Planned Parenthood, as well as the Roman Catholic Church’s response to President Obama’s proposed healthcare mandate have many wondering: What’s wrong with contraceptives?
For over 50 years, we’ve heard that pills, injections, devices, and hormones will prevent “unwanted” pregnancy, protect women’s health and stop everything from AIDS to acne, creating a happy, healthy, and sexually fulfilled generation of men and women.
After more than 40 years of government-subsidized contraceptives, why shouldn’t we welcome additional healthcare packages that require an assortment of miracle drugs and preventative hormones to be offered by every employer? Part of the answer lies in the stunning facts about the collective failure of these products to deliver on their promises:
As we consider whether our future health care should include contraceptives, let’s remember that many who suffer because of a previous abortion or STI have relied on their false promises. The pursuit of true sexual intimacy—joyfully building a family and strengthening a lifetime commitment—has been replaced by a false notion that, given the proper health care, we can control or eliminate the inconvenient “outcomes” of sex.
So, what’s wrong with contraceptives? Before we even enter into the moral, economic, or social arguments, the answer is clear: They simply don’t work as promised.
While contraceptives entrench themselves as the gateway drug to abortion, birth control proponents are still stuck in the mid-20th century, clinging to the hopeless assertions that if we just spend more, educate earlier and use birth control “better,” the desired outcomes will one day kick in.
After four decades of government-funded birth control, and all our best efforts to create a world where sex has no consequences, are we any better off? You decide.
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