Safety Of Oral Contraceptives Research Articles

Progestogen only contraception in women with congenital heart disease

Background There is little information of progestogen-only contraceptives in patients with congenital heart disease (CHD) on the long-term. Objective To evaluate the use of contraception in patients with CHD. We studied both short-acting reversible contraceptives (SARCs), oral progestin-only pills (POPs) and long-acting reversible contraceptives (LARCs): intrauterine devices (IUD-IPs) and subdermal implants both impregnated with progestogens (SI-IPs). Study design Retrospective study of all women attending the preconception clinic. Contraceptive methods were classified in three TIERs of effectiveness before and after consultation. ESC classification regarding pregnancy risk, WHOMEC classification for combined oral contraceptive safety was collected. Results Six hundred and fifty-three patients. A significant proportion of them switched from TIER 3 to TIER 2 or 1 (p < .001) after consultation. One hundred and ninety-nine patients used POPs, 53 underwent IUD-IPs implantation and 36 SI-IPs, mean duration was 58 ± 8, 59 ± 8 and 53 ± 38 months, respectively. Conclusions Because of their safety and efficacy, IUD-IPs and SI-IPs should be considered as first-line contraception in patients with CHD.

Thromboembolic safety of norethisterone vs levonorgestrel in combined oral contraceptive users: a pooled analysis of 4 large prospective cohort studies

BACKGROUNDNorethisterone (acetate) and levonorgestrel are marketed globally as components of combined oral contraceptives. Although guidelines recommend both as first-line combined oral contraceptives, no direct, comparative safety studies are available.OBJECTIVEWe directly compared the thromboembolic event risk associated with the use of norethisterone acetate-containing and levonorgestrel-containing combined oral contraceptives.STUDY DESIGNData regarding the cohorts of interest, norethisterone/norethisterone acetate (ethinylestradiol ≤30 µg) and levonorgestrel (ethinylestradiol ≤30 µg), were retrieved from a pooled dataset comprising 4 prospective, noninterventional, active-surveillance cohort studies in 14 European countries, the United States, and Canada, with similar study design but differing medication cohorts. Baseline characteristics and parameters of reproductive, contraceptive, and medical history were summarized using descriptive statistics. Propensity score subclassification was applied to balance baseline parameters between cohorts. Time-to-event analysis of venous thromboembolic events was performed on the basis of the extended Cox model to calculate crude and adjusted hazard ratios, including 95% confidence intervals. The time of venous thromboembolic events was censored at the end of the observation period for women who did not have an event. Women who dropped out or were lost to follow-up without reported venous thromboembolic events were censored at the time they last confirmed that they did not have an event.RESULTSThe pooled dataset included 235,437 combined oral contraceptive users who were followed up for a total of 571,163 women years. Among these, 40,142 women were users of norethisterone/norethisterone acetate (ethinylestradiol ≤30 µg), and 39,098 women were users of levonorgestrel (ethinylestradiol ≤30 µg), contributing 61,976 and 84,816 women years of observation, respectively. The observed prevalence of prognostic factors at baseline showed typical features of US and European combined oral contraceptive users. Both cohorts showed a similar, low rate of thromboembolic events, and we could exclude a 1.5-fold increased venous thromboembolism risk for norethisterone/norethisterone acetate relative to levonorgestrel (adjusted hazard ratio, 0.73; 95% confidence interval, 0.48–1.11).CONCLUSIONThese data confirm the similar risk profiles of norethisterone/norethisterone acetate and levonorgestrel regarding thromboembolic events in routine combined oral contraceptive use of around 80,000 women from Europe and the United States/Canada. The analysis provides reassurance for both combined oral contraceptive users and clinicians regarding the safety of oral contraceptives and potentially opens discussion on norethisterone acetate as a potential gold standard therapy in clinical and postmarket research alongside levonorgestrel-combined oral contraceptives.

Perceptions of health risks associated with pregnancy compared to oral contraceptive use

ObjectiveTo assess beliefs about the safety of oral contraceptives compared to pregnancy to determine if men and women possess accurate information to make informed choices. Study designIn each of six surveys conducted in Southern California from 2008 to 2017, participants were asked “Which do you think is more hazardous to a woman's health — birth control pills or pregnancy?” ResultsA total of 28.4% of all 1839 male and female respondents and 29.1% of the 1712 female respondents answered correctly that the health risks posed by pregnancy were greater. In subgroup analyses, 64.4%–81.9% rated oral contraceptives at least as hazardous to a woman's health as pregnancy. ConclusionThe vast majority of respondents incorrectly believed that oral contraceptives are more hazardous than pregnancy. ImplicationsHealth decision making relies upon patients' understanding of the relative risks and benefits of each available option. Most sexually active women do not understand that there is no contraceptive method current guidelines would offer them that is as hazardous to their health as pregnancy. Such misconceptions can lead to risky decisions. Clinicians need to explicitly provide their sexually active patients more accurate and balanced information, putting contraception in the context of its probable alternative — pregnancy.

Hormones and risk of breast and gynecological cancer

Background Breast and gynecological cancers are often hormone dependent. The role of reproductive factors and endogenous hormones in tumorigenesis of these tumors has been investigated in numerous studies. Safety of oral contraception, hormone therapy during perimenopause or postmenopause or fertility treatment is of special interest for the information of women who are planning to use these therapies.

Women with epilepsy initiating a progestin IUD: A prospective pilot study of safety and acceptability

Effective contraception enables women with epilepsy (WWE) to plan their pregnancies and improve outcomes for themselves and their children. Although popular among all women, complex drug interactions limit the efficacy and safety of oral contraceptives (OCs) for WWE. We sought to explore the safety, acceptability, and pharmacokinetic impact of a progestin-containing intrauterine device (IUD) in WWE. We enrolled 20 women with well-controlled epilepsy and a stable antiepileptic drug (AED) regimen and who were initiating a progestin-containing IUD (levonorgestrel 52 mg) in a prospective, observational study. For each AED, we compared the trough concentration before IUD insertion to the trough concentration 3 weeks, and 3 and 6 months later. Participants recorded seizures in a daily paper diary. We compared seizures that occurred during the month before IUD insertion to those occurring in the 6 months thereafter. Participants completed an acceptability questionnaire at 3 and 6 months. Participants' average age was 28 years; 60% were nulligravid. They reported a history of multiple seizure types. During the baseline month, 75% were seizure-free and the remainder reported between one and three seizures. Fourteen received monotherapy and six received polytherapy. Lamotrigine use was most common (n = 12). AED trough concentrations remained stable during the 6 months after IUD insertion, without clinically meaningful deviations from baseline. Diary data showed that seizure frequency worsened in 3, and remained unchanged in 13 and improved in 4 after IUD insertion. Subjectively, no participant believed the IUD worsened her seizure control. All participants were either somewhat or very satisfied with the IUD throughout the study. All participants continued the IUD use at 6 months. No pregnancies occurred. This pilot study suggests that the progestin-containing IUD is a safe and acceptable long-acting contraceptive for WWE.

Endocrine interventions in women with BRCA1/2 mutations

One in eight women will be diagnosed with breast cancer and 5 % of all breast cancer cases are attributable to a mutation in BRCA1 or BRCA2. Lifetime risk of the general population is about 1.5 %. The probability of an underlying mutation depends on family history, histologic subtype and age at diagnosis. For healthy BRCA1/2 mutation carriers, ovarian cancer risk varies between 15 and 60 % depending of the mutation and modifying factors. The safety of endocrine interventions in BRCA1/2 mutation carriers has been investigated in numerous trials. In this article an update on the current knowledge on safety of oral contraception, hormone therapy and fertility treatment in BRCA1/2 mutation carriers is provided. Furthermore, options for primary prevention are discussed. A systematic search in the Medline literature database through PubMed using the terms “BRCA”, “famil*”, “breast cancer”, “ovarian cancer”, “oral contraception”, “fertility”, “fertility treatment”, “infertility”, “tamoxifen”, “raloxifene”, “chemoprevention”, “prevention”, “hormone”, “hormone treatment”, “hormone therapy”, “salpingo-oophorectomy” and “endocrine” was performed. Articles published between 1995 and 2015 were included. Oral contraceptives seem to slightly increase the breast cancer risk of BRCA1/2 mutation carriers, but they also have a tremendous protective effect against ovarian cancer. Parity, breastfeeding and fertility treatment do not seem to influence cancer risk in these women. Hormone therapy should be offered after risk-reducing salpingo-oophorectomy to limit osteoporosis and cardiac mortality. Tamoxifen and raloxifene are effective for primary prevention of breast cancer in BRCA1/2 mutation carriers; however possible adverse effects must be considered.

NICE's latest guidelines on diabetes in pregnancy: getting the balance right

<scp>NICE</scp>'s latest guidelines on diabetes in pregnancy: getting the balance right

Metafolin in combined oral contraceptives – investments in reproductive welfare. World news: modern contraception – opportunity of pregravidarum preparing

This article is a review of the material on the key studies that demonstrated in women of reproductive age, especially considering pregnancy the efficacy and safety of oral contraceptives containing ethinylestradiol and drospirenone combined with the active form of folic acid. Such combination provide increased folate levels in red blood cells and in plasma, reduced homocysteine levels in the blood plasma, thereby significantly reduce the probability of abnormal fetus development. The expediency of receiving data combined drugs proved not only for contraception, but also for pregravidarum preparing – to normalize the folate status of women requires minimum 16 weeks of exogenous folate intake, and the probability of pregnancy is very high right after the withdrawal combined oral contraceptives.

Metafolin in combined oral contraceptives – investments in reproductive welfare. World news: modern contraception – new opportunity of pregravidarum preparing

This article is a review of the material on the key studies that demonstrated in women of reproductive age, especially considering pregnancy the efficacy and safety of oral contraceptives containing ethinylestradiol and drospirenone combined with the active form of folic acid. Such combination provide increased folate levels in red blood cells and in plasma, reduced homocysteine levels in the blood plasma, thereby significantly reduce the probability of abnormal fetus development. The expediency of receiving data combined drugs proved not only for contraception, but also for pregravidarum preparing – to normalize the folate status of women requires minimum 16 weeks of exogenous folate intake, because the probability of pregnancy is very high right after the withdrawal combined oral contraceptives.

Physician Attitudes Toward Over the Counter Availability for Oral Contraceptives

To assess physician attitude towards making oral contraceptives available over the counter in the United States (US). We assessed physician attitudes towards a transition from prescription only to over-the-counter availability (rx-OTC) for oral contraceptive pills by disseminating an electronic survey directed primarily to residents training in Obstetrics and Gynecology (OBGYN) and Family Practice in the US. An overwhelming majority of 638 respondents (71 %) were against an rx-OTC switch for combined oral contraceptives and among this subset of respondents the primary concern was safety (92.3 %). Overall, respondents were evenly divided on the issue of an rx-OTC switch for progestin-only-pills but of those who opposed, 73.2 % cited safety as their primary concern. For progestin-only-pills female respondents were more likely to support OTC availability. Most OBGYN and Family Practice residents opposed to OTC availability for oral contraceptives cite safety as their primary concern. Considering the abundant evidence as to the overall safety of oral contraceptives, especially progestin-only-pills, there appears to be a knowledge deficit among OBGYN and Family Practice residents regarding the safety of oral contraceptives.

Health Risk Screening Practices of Pharmacy and Chemist Shops in Selling Oral Contraceptives to Women in Jos Metropolis

Background: In Nigeria, oral contraceptives are widely available in the informal health sector without prescription. Whilst oral contraceptives are generally safe, most physicians agree that they should not be given to everyone. Certain health risk factors are contraindications for the use of oral contraceptives. I nformal facilities, like Pharmacy and Chemist shops are the main sources for obtaining oral contraceptives in Nigeria. Studies have shown that informal health providers in Pharmacy and Chemist shops can screen for these factors when women come to purchase oral contraceptives. This study examines the screening practices of pharmacy and chemist shops in Jos metropolis.Methodology: Fifty two pharmacy and chemist shops were selected using simple random number sampling technique from 120 registered pharmacy and chemist shops in Jos Metropolis. A semi-structured questionnaire, examining the screening practice of the sales persons was interviewer administered to all the sales persons in the shops. Results: Eighty six (86) sales persons were interviewed. 51(59.3%) were females and 50(57.7%) had completed secondary school education. Twelve (13.9%) of the respondents had some form of on the job training for screening women who come to buy oral contraceptives. Twenty eight (32.7%) of the respondents did not ask any question from the women who buy oral contraceptives. Those who asked questions did not know the correct responses expected or why the questions were important. None of the respondents knew that diabetes, breast diseases and obesity were contraindications to the use of oral contraceptivesConclusion: Screening practices are poor and persons who sell oral contraceptives to women have a poor knowledge of health risk factors that are contraindications to the use of oral contraceptives. Sales persons should be trained on screening methods and information about oral contraceptive safety and their contraindications be made available to women.

RETIRED: Oral Contraceptives and the Risk of Venous Thromboembolism: An Update

To provide current and emerging evidence on oral contraceptives and the risk of venous thromboembolism.Articles published in English from 2005 were retrieved through searches of PubMed and Medline, using the following terms: venous thromboembolism, VTE, contraception, oral contraceptives, hormonal contraception. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. Searches were updated on a regular basis and incorporated in the guideline to May 2010. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies.The quality of evidence was rated using the criteria described by the Canadian Task Force on Preventive Health Care (Table). SUMMARY STATEMENTS: 1. Modern oral contraceptives offer highly effective contraception and a range of non-contraceptive benefits. (I) 2. Venous thromboembolism, although rare, remains one of the serious adverse consequences of hormonal contraception. Best evidence indicates that venous thromboembolism rates in non-users of reproductive age approximate 4-5/10 000 women per year; rates in oral contraceptive users are in the range of 9-10/10 000 women per year. For comparison, venous thromboembolism rates in pregnancy approach 29/10 000 overall and may reach 300-400/10 000 in the immediate postpartum period. (II-1) 3. Research demonstrates that oral contraceptives with ≤ 35 µg of ethinyl estradiol carry a lower risk of venous thromboembolism than oral contraceptives with 50 µg. (II-2) Although preliminary data suggest a possible further reduction in venous thromboembolism with oral contraceptives with < 35 µg ethinyl estradiol, robust data to support this conclusion are presently lacking. 4. Recent contradictory evidence and the ensuing media coverage of the venous thromboembolism risk attributed to the progestin component of certain newer oral contraceptive products have led to fear and confusion about the safety of oral contraceptives in general and drospirenone-containing oral contraceptives in particular. "Pill scares" of this nature have occurred in the past, with panic stopping of the pill, increased rates of unplanned pregnancy, and no subsequent decrease in venous thromboembolism rates. (II-3) 5. Two high quality research studies that addressed the venous thromboembolism risk associated with various oral contraceptives found comparable venous thromboembolism rates with drospirenone-containing oral contraceptives and other approved products. (II-1) 6. Two reports suggesting an increased risk of venous thromboembolism with drospirenone-containing oral contraceptives have significant methodological flaws that render their conclusions suspect. It seems likely that residual confounding could have distorted both the results and the conclusions of these reports. (II-3).

Margaret Marsh and Wanda Ronner, The Fertility Doctor: John Rock and the Reproductive Revolution

John Rock is best known as the Roman Catholic gynaecologist who led the clinical trials of oral contraceptives in the 1950s and became the voice of lay persons who believed that the time had come for the Church to accept ‘the pill’ as a morally permissible alternative to the rhythm method during the middle 1960s, when Pope Paul VI created a special commission on population and the family. The optimism among liberals was dampened by the papal encyclical Humanae Vitae in July 1968, which affirmed traditional doctrine without equivocation. During this period of ferment, Rock was awarded an honorary doctor of laws degree by Harvard (1966), and a majority of American Catholics accepted Rock's view that fertility control was a key to successful marriage. Beginning in the 1970s, Rock's immense popularity and intellectual prestige would diminish as debates raged over the safety of oral contraceptives, the consensus over the necessity for population control to prevent ecocatastrophe waned, and neo-conservatives found common ground in opposition to abortion and the sexual permissiveness that seemed boundless before AIDS dampened the enthusiasm for sexual liberation in the 1980s. When Rock died in 1984 at the age of ninety-two, his legacy seemed very much in dispute.

Perceptions of the safety of oral contraceptives among a predominantly Latina population in Texas

Background Fear of side effects and previous negative experiences are common reasons for contraceptive nonuse. Study Design We collected information about perceptions of oral contraceptive (OC) safety from 1271 women 18-49 years old in El Paso, TX, and compared their responses to a medical evaluation by a nurse practitioner. We also asked participants about their interest in obtaining OCs over the counter (OTC). Results Among 794 women potentially at risk of unintended pregnancy, 56.0% said that OCs were medically safe for them. Reasons given for OCs being unsafe were related to fears of side effects and prior negative experiences rather than true contraindications. Older women and participants recruited at the less affluent recruitment site were significantly more likely to report that OCs were medically unsafe for them (p<.05). Nonusers who thought OCs were medically unsafe for them were as likely to be medically eligible for use as current hormonal users. Among nonusers or nonhormonal users and potential OC candidates ( n=601), 60.2% said they would be more likely to use OCs if they were available OTC. Conclusions Women's perception of OC safety does not correlate well with medical eligibility for use. More education about the safety and health benefits of hormonal contraception is needed. OTC availability might contribute to more positive safety perceptions of OCs compared to a prescription environment.

Accuracy of Self-Screening for Contraindications to Combined Oral Contraceptive Use

To estimate how well a convenience sample of women from the general population could self-screen for contraindications to combined oral contraceptives using a medical checklist. Women 18-49 years old (N=1,271) were recruited at two shopping malls and a flea market in El Paso, Texas, and asked first whether they thought birth control pills were medically safe for them. They then used a checklist to determine the presence of level 3 or 4 contraindications to combined oral contraceptives according to the World Health Organization Medical Eligibility Criteria. The women then were interviewed by a blinded nurse practitioner, who also measured blood pressure. The sensitivity of the unaided self-screen to detect true contraindications was 56.2% (95% confidence interval [CI] 51.7-60.6%), and specificity was 57.6% (95% CI 54.0-61.1%). The sensitivity of the checklist to detect true contraindications was 83.2% (95% CI 79.5-86.3%), and specificity was 88.8% (95% CI 86.3-90.9%). Using the checklist, 6.6% (95% CI 5.2-8.0%) of women incorrectly thought they were eligible for use when, in fact, they were contraindicated, largely because of unrecognized hypertension. Seven percent (95% CI 5.4-8.2%) of women incorrectly thought they were contraindicated when they truly were not, primarily because of misclassification of migraine headaches. In regression analysis, younger women, more educated women, and Spanish speakers were significantly more likely to correctly self-screen (P<.05). Self-screening for contraindications to oral contraceptives using a medical checklist is relatively accurate. Unaided screening is inaccurate and reflects common misperceptions about the safety of oral contraceptives. Over-the-counter provision of this method likely would be safe, especially for younger women and if independent blood pressure screening were encouraged.

Migraine and Cardiocerebrovascular Risk in Women

The interest of the medical community has recently focused on the relationship between gender and cardiocerebrovascular risk. In this paper, we will first review gender differences in cardiocerebrovascular disorders, then we will discuss the existing evidence on the links between migraine and stroke and cardiovascular disease in women, and speculate on the possible physiopathological interpretations of this emerging epidemiological link. In the third part of this work, we will address the issue of the effect of sex hormones on vascular risk, and consider the evidence concerning the safety of oral contraceptives and hormone-replacement therapy. Finally, we will outline the main trends of future research and its possible clinical and therapeutic implications.

Oral Contraceptive Safety Reviewed in Adolescents

Oral Contraceptive Safety Reviewed in Adolescents

Contraceptive treatment after biliopancreatic diversion needs consensus.

An important population of patients who undergo biliopancreatic diversion (BPD) are fertile women. A consensus is needed with regard to contraceptive therapy after BPD by evaluating the risks of pregnancy, the safety of oral contraception and the changes in fertility after this bariatric surgery. From May 1997 until May 1998, 40 women who underwent a BPD were included in a prospective study evaluating the hormone status preoperatively and postoperatively after 2 and 7 days, 3 and 6 months and 1 year. An extensive questionnaire, with regard to fertility and obstetric history, was sent at least 2 years after inclusion. A literature search was performed to understand the complex physiology of hormone changes after excess weight loss, as well as absorption and metabolism of oral contraceptives. Our laboratory results are consistent with hormone changes found in the literature, which show that rising levels of serum sex-hormone-binding globulin, follicle stimulating hormone and luteinizing hormone and decreasing levels of testosterone and dehydroepiandrosterone sulphate result in an improved fertility status, regulated through complex interactions, in particular with the gonatotropin-releasing-hormone pulse generator. The questionnaire shows the use of different types of contraception. From the 9 patients who only used oral contraception, 2 patients developed an unforeseen pregnancy after BPD. Although miscarriages and neonatal complications were seen in other patients in our hospital, none of these problems were seen in our study. Pregnancy should be avoided for 12 to 18 months after BPD. Fertility increases after BPD. As oral contraception is most popular and less reliable, we strongly believe that large multi-centre, prospective, randomized studies are necessary to come to a consensus about the use of contraceptive therapy after BPD.

The recent saga of cardiovascular disease and safety of oral contraceptives.

This review presents detailed risk estimates from relevant epidemiological and other studies on the comparative safety of second and third generation oral contraceptives (OC). Written with the intention of presenting a repository of the available information, it also discourses briefly into the symptomatology and diagnosis of diseases associated with OC use and presents some of the critical comments made about various epidemiological analyses. A general critique including observations and opinions of various investigators completes the review. We stress that our own opinions on the various studies, or an attempt to adjudge the relative safety of second and third generation OC, are not given since they form the substance of our second paper which completes this symposium.

Oral contraceptives and compliance: reaction to cardiovascular alarm among users.

The effectiveness of oral contraceptives (OC) is dependent on correct daily intake as well as continuous use. The latest cardiovascular alarm in 1995 led to discontinuations, presumably due to concerns about the long-term safety of OCs. The aim of this study was to investigate women's experiences and concerns about OCs in general as well as after the latest cardiovascular alarm. In 1993 and 1996, questionnaires were offered to 645 and 644 consecutive women visiting a midwife or a gynecologist at eleven family planning clinics in order to get their first prescription of oral contraceptives or to renew their prescription. The study was carried out in Uppsala, a city in Sweden with 180000 inhabitants. In 1993, 95%, answered the questionnaire and in 1996 the corresponding figure was 92%. Change of brand was common and increased from 38% in 1993 to 44% in 1996. Mild side-effects were reported by about 25%. Concerns about oral contraceptives increased from 36% to 41% (p < 0.01), particularly regarding the risk for thrombosis. Fewer than 1% expressed this concern in 1993 but 29% did so in 1996. Negative media coverage leads to increased concerns and declining confidence among users of oral contraceptives and has to be met by adequate oral and written information by the counsellor.