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Your search found 27 Results

  1. 1

    New warning: Morning-after pill doesn't work for women over 176 pounds.

    Redden M

    Mother Jones. 2013 Nov 25; [10] p.

    The European manufacturer of an emergency contraceptive pill identical to Plan B, also known as the morning-after pill, will warn women that the drug is completely ineffective for women who weigh more than 176 pounds and begins to lose effectiveness in women who weigh more than 165 pounds. HRA Pharma, the French manufacturer of the European drug, Norlevo, is changing its packaging information to reflect the weight limits. European pharmaceutical regulators approved the change on November 10, but it has not been previously reported. This development has implications for American women. Some of the most popular emergency contraceptive pills sold over the counter in the United States --including the onepill drugs Plan B One-Step, Next Choice One Dose, and My Way, and a number of generic two-pill emergency contraceptives -- have a dosage and chemical makeup identical to the European drug. Weight data from the Centers for Disease Control and Prevention (CDC) suggests that, at 166 pounds, the average American woman is too heavy to use these pills effectively. (Excerpt)
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  2. 2
    Peer Reviewed

    Aligning new interventions with developing country health systems: Target product profiles, presentation, and clinical trial design.

    Brooks A; Nunes JK; Garnett A; Biellik R; Leboulleux D; Birkett AJ; Loucq C

    Global Public Health. 2012 Oct; 7(9):931-945.

    Many new interventions are being created to address health problems of the developing world. However, many developing countries have fragile health systems and find it difficult to accommodate change. Consequently, it is essential that new interventions are well aligned with health systems and their users. Establishing target product profiles (TPPs) is a critical, early step towards tailoring interventions to suit both of these constituencies. Specific analyses can help identify and establish relevant TPP criteria such as optimal formulation, presentation and packaging. Clinical trials for a new intervention should be designed to address both TPP-specific questions and anticipated use of the intervention in target countries. Examples are provided from research on malaria vaccines that are also applicable to other new public health interventions.
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  3. 3

    Breakeven analysis for various human papillomavirus vaccine presentations in Vietnam and Uganda.

    Lorenson K; Garnett A; Kristensen D; Nga N

    Seattle, Washington, PATH, 2010 Aug. [20] p.

    The study highlighted in this project Optimize report uses a breakeven cost analysis to compare potential prices, wastage rates, and cold chain requirements for various human papillomavirus (HPV) vaccine presentations.
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  4. 4

    FDA notifications. FDA approves new atazanavir labeling.

    AIDS Alert. 2011 Mar; 26(3):33-4.

    In February of 2011, the Food and Drug Administration (FDA) approved new labeling for the antiretroviral drug atazanavir (Reyataz) to include dosing recommendations for treatment of HIV-1 infection during pregnancy and postpartum period. The major revisions to the package insert are summarized in this report, as well as other minor changes made for consistency.
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  5. 5
    Peer Reviewed

    An Over-the-Counter Simulation Study of a Single-Tablet Emergency Contraceptive in Young Females.

    Raine TR; Ricciotti N; Sokoloff A; Brown BA; Hummel A; Harper CC

    Obstetrics and Gynecology. 2012 Apr; 119(4):772-779.

    OBJECTIVES:: To evaluate use of a single-tablet (levonorgestrel 1.5 mg) emergency contraceptive administered to young females under simulated over-the-counter conditions. Secondary objectives were to assess repeat use, pregnancy, and adverse events. METHODS:: Females aged 11-17 years requesting emergency contraception at teen reproductive health clinics in five cities were eligible to participate. Participants read the study product label and determined whether and how to use the product without interacting with providers. Study product was dispensed to participants who appropriately selected to use it; participants were contacted 1, 4, and 8 weeks later to assess use, pregnancy, and adverse events. The incidences of outcomes were calculated and regression analysis was used to assess the effect of age and use status (ever used or no previous use) on primary outcomes. RESULTS:: Of the 345 females enrolled, 279 were younger than age 17 years. Among the 340 participants included in the selection analysis, 311 (91.5%) (97.5% confidence interval 87.5- 94.5%) participants appropriately selected to use or not use product. Among the 298 participants who used product, 274 (92.9%) (97.5% confidence interval 88.8-95.8%) correctly used it as labeled. Selection and correct use were not associated with age. Fifty-seven participants (18.8%) used additional emergency contraception over the study period and seven (2.3%) participants who used product became pregnant; there were no unusual adverse events. CONCLUSION:: Restricting young females' use of a single-tablet emergency contraceptive by prescription only is not warranted, because females younger than 17 years can use it in a manner consistent with over-the-counter access. LEVEL OF EVIDENCE:: II.
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  6. 6

    Training manual. Training providers on packaging nevirapine oral suspension using the nevirapine infant-dose pouch.

    Program for Appropriate Technology in Health [PATH]

    Seattle, Washington, PATH, 2006 Aug. [11] p. (USAID Cooperative Agreement No. GPH-A-00-01-00005-00; USAID Development Experience Clearinghouse DocID / Order No. PN-ADI-174)

    This training manual was developed to assist programs planning to introduce the nevirapine infant-dose pouch into prevention of mother-to-child transmission of HIV/AIDS (PMTCT) programs. This brief manual is intended for adaptation by programs and can be implemented by itself or integrated into ongoing training. (excerpt)
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  7. 7

    Sourcing guide. The nevirapine infant-dose pouch for use in prevention of mother-to-child transmission of HIV / AIDS programs. Version 1.

    Program for Appropriate Technology in Health [PATH]

    Seattle, Washington, PATH, 2006 Aug. 23 p. (USAID Cooperative Agreement No. GHA-A-00-01-00005-00; USAID Development Experience Clearinghouse DocID / Order No. PN-ADI-175)

    As part of a public-private partnership with the US Agency for International Development (USAID) and Boehringer Ingelheim (BI; manufacturer of Viramune®1 brand nevirapine), PATH developed a simple solution, the nevirapine (NVP) infant-dose pouch. This pouch can help prevention of mother-to-child transmission of HIV/AIDS (PMTCT) programs overcome the packaging challenges to increased coverage of at-risk newborns with the infant dose of NVP. The purpose of the Sourcing Guide is to provide PMTCT programs with the information they would need to independently procure NVP infant-dose pouches for use in PMTCT services. While PATH developed the NVP infant-dose pouch and validated its use in the field, PATH is not a manufacturer or supplier of the pouch. PATH's design for the pouch uses readily available packaging materials and processes which may be locally available in many countries. This guide will help programs either: Procure pouches from a current manufacturer(s) identified by PATH; or Engage a local or regional packaging manufacturer to produce pouches of similar function and quality. (excerpt)
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  8. 8

    Oral rehydration salts. Production of the new ORS.

    World Health Organization [WHO]. Department of Child and Adolescent Health and Development; UNICEF. Supply Division

    Geneva, Switzerland, WHO, 2006. [122] p. (WHO/FCH/CAH/06.1)

    This document is updating an earlier document (WHO/CDD/SER/85.8), and provides information on the manufacture of the new ORS that, since 2003, is recommended by WHO and UNICEF. It has been prepared to assist national authorities in establishing the local manufacture of a product of pharmaceutical quality, in order that they may become self-reliant in meeting the needs of their national diarrhoeal diseases control activities. It is emphasized that the methods recommended in the document are meant to serve as guidelines, and that they need to be adapted to meet local requirements and conditions, provided they follow the principles of Good Manufacturing Practices for pharmaceutical products (WHO Technical Report Series, No 908, 2003) that can be found in the annexes of this document. Specific information on "Quality Management", "Personnel", "Validation" and "Qualification" can be found in this annex. (excerpt)
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  9. 9

    Emergency contraception. ECPs: instructions for use.

    Program for Appropriate Technology in Health [PATH]; Northwest Emergency Contraception Coalition

    Seattle, Washington, PATH, 1998. [1] p.

    Emergency Contraceptive Pills (ECPs) must be taken within 3 days after sex. Any of the birth control pills listed below can be used as ECPs. Use only the type of pill your health care provider prescribed for you. Use only one type of pill. One hour before the first ECP dose, take an anti- nausea medicine (like Dramamine II or Benadryl) to reduce the chance of nausea. Repeat according to labeled instructions. This may make you feel tired, so don't drive or drink any alcohol. Take the first ECP dose as soon as convenient within 3 days (72 hours) after unprotected sex (try to time the first dose so that the timing of the second dose will be convenient). Take the second ECP dose 12 hours after the first dose. Important: Do not take any extra ECPs. More pills will not make the treatment work better. More pills will increase your risk of feeling sick to your stomach. (excerpt)
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  10. 10

    Access to HIV / AIDS drugs and diagnostics of acceptable quality. Procurement Quality and Sourcing project. Manufacturers and suppliers whose HIV-related medicines have been found acceptable, in principle, for procurement by UN agencies. 18th ed.

    World Health Organization [WHO]; UNICEF; Joint United Nations Programme on HIV / AIDS [UNAIDS]; United Nations Population Fund [UNFPA]

    Geneva, Switzerland, WHO, 2004 Aug 9. 19 p.

    A "Procurement, Quality and Sourcing Project: Access to HIV/AIDS drugs and diagnostics of acceptable quality" was actively started by WHO in collaboration with other United Nations Organizations (UNAIDS, UNICEF, and UNFPA) in March 2001. The World Bank supports this initiative. The background to the project is described in the project description. The procedure for assessing the acceptability in principle of HIV/AIDS drugs comprises various components including 1) The evaluation of product data and information provided by manufacturers and suppliers, and 2) Inspection of manufacturing sites. Due to the particular properties of several substances used in some pharmaceutical finished dosage forms in the treatment of HIV/AIDS (e.g. chiral activity, isomerism, sensitivity to relative humidity etc.), and the current status where there are no Pharmacopoeia monographs and standards available for several substances and finished products, WHO appointed experts have performed a comprehensive and rigorous evaluation of the products included in the list, with a view to establishing their compliance with international standards. (excerpt)
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  11. 11
    Peer Reviewed

    First chewable OC enters U.S. market.

    Contraceptive Technology Update. 2004 Feb; 25(2):[2] p..

    Successful pill-taking is an important component for women who use oral contraceptives (OCs). Inconsistent use and method discontinuation are estimated to account for approximately 20% of the annual 3.5 million annual unintended pregnancies in the United States. Will a chewable contraceptive aid in pill-taking compliance? The Food and Drug Administration (FDA) has just approved the first such product. Look for the launch of Ovcon 35 in late spring, says Katie MacFarlane, PharmD, vice president of marketing for Galen Holdings and Warner Chilcott, based in Rockaway, NJ. When a pill is reformulated into a chewable form, it must be flavored to mask the chalky taste of the active ingredient, says Jeff Worthington, managing director of food and pharmaceutical technologies at Cambridge, MA-based TIAX, an independent and privately held technology development and consulting firm that aids companies in developing palatable pharmaceuticals, nutritional products, foods, and beverages. (excerpt)
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  12. 12

    Costing nevirapine delivery to infants: a Zambian case study.

    Zellner S; Musau S

    Bethesda, Maryland, Abt Associates, Partners for Health Reform Plus Project, 2004 Aug. [36] p. (USAID Contract No. HRN-C-00-00-00019-00)

    The United States Agency for International Development invited the Partners for Health Reformplus to estimate costs associated with the packaging of infant doses of Nevirapine in Zambia. The costs of following four scenarios were examined in this exercise: 1) preparation and administration of Nevirapine by a nurse immediately after birth, 2) preparation of Nevirapine in batches prepared by either a nurse or nurse’s aide, 3) a semi-automated approach of pre-filled and packaged Nevirapine syringes, and 4) a fully automated approach using UnijectDP pre-filled with Nevirapine. Findings show that, at all dose levels, administration by a nurse after birth is the most cost-effective scenario. However, if other important factors, such as limited access to hospital facilities, are taken into consideration, then the semi-automated or Uniject approaches may be more suitable. (author's)
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  13. 13

    8 February 1991 summary minutes.

    United States. Food and Drug Administration [FDA]. Center for Drug Evaluation and Research. Fertility and Maternal Health Drugs Advisory Committee

    [Unpublished] 1991 Feb. [9] p.

    The summary minutes of the FDA Fertility and Maternal Health Drugs Advisory Committee (2/8/91) focused on improved instructions for taking oral contraceptives (OC). 6 speakers addressed the following items: topic introduction, open hearings with speakers, overview, analysis of current instruction, presentation of new draft OC instruction, justification for changes, manufacturer's instructions, and domestic and international implications. The Committee agreed unanimously with Family Health International (FHI) general recommendations that standardizing and simplifying the OC instructions might increase correct and continued use of this product. The Committee agreed unanimously with FHI's specific recommendation that the patient package insert 1) must be written at 5th and 6th grade reading level with easily understandable words and phrases, 2) must use large print, 3) must display the picture of the pill pack, and 4) must clearly indicate on the pill pack weeks of use: 3 weeks of active and 1 week of inactive pills, the 1st pill, and the directions for pill taking. The Committee unanimously agreed the FHI's specific recommendation for advice on using correct and effective OC as in: 1) taking the pill, 2) when to start the 1st pack of pills, 3) what to do during the month, and what to do if you miss pills, 4) what to do if you miss pills with a start day of Sunday, and 5), with a not on Sunday start day. Discussants represented FHI, International Planned Parenthood, the American College of Obstetrics and Gynecology, and the University Hospital of South Manchester, UK. In the public comments session the speakers who made a presentation represented the Association of Reproductive Health Professionals, Planned Parenthood Federation of America, the National Health Network, Emory School of Medicine, and NIH. A complete transcript is available. Future meeting dates were set.
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  14. 14

    Emergency contraception. The pill's little-known secret goes public.

    Chez RA; Chapin J

    LIFELINES. 1997 Oct; 1(5):28-31.

    The use of combined oral contraceptives (OCs) for emergency contraception represents an important strategy for preventing unwanted pregnancy. Despite the efficacy of this approach and its recent (1997) approval by the US Food and Drug Administration, many health care providers remain uninformed. In response, several national organizations--including the American College of Obstetricians and Gynecologists' Program for Appropriate Technology in Health--are launching information initiatives about this use of OCs. In anticipation of increased requests from US women for postcoital contraception, clinical facilities are urged to create practice guidelines for counseling and method distribution. Women should be advised to take the initial dose of the appropriate number and color of combination of OCs within 72 hours of exposure, followed by a second dose 12 hours later. Increased awareness of OCs as emergency contraception could result in separate packaging of the two doses of four combination pills along with patient instructions. Were such a product to be packaged, family planning clients could be provided with emergency contraception at the same time they receive prescriptions for a regular contraceptive method.
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  15. 15

    Estrogen dose in oral contraceptives: FDA committee examines safety and utility of 50 mcg estrogen OCs.

    CONTRACEPTION REPORT. 1994 Mar; 5(1):10-3.

    In July, 1993, the US Food and Drug Administration (FDA) sent a letter to manufacturers of oral contraceptives (OCs) to inform them about reports of reduced risk of thromboembolic events linked to OCs with less than 50 mcg estrogen, and to ask them to voluntarily withdraw 50 mcg OCs from the market. In October, 1993, FDA's Fertility and Maternal Health Drugs Advisory Committee met to discuss the relative safety and utility of OCs with 50 mcg estrogen. 15% of women at least 45 years old who were using OCs were taking OCs with 50 mcg estrogen. Some gynecologists justified continuation of the higher-dose OC in this age group by claiming that the high dose was needed to treat breakthrough bleeding, which in turn improves user compliance, continuation, and contraceptive effectiveness. Since rifampin, phenytoin, phenobarbital, griseofulvin, and (possibly) long-term use of tetracycline reduce contraceptive effectiveness, physicians prefer 50 mcg estrogen OCs for women taking them. One committee member was concerned with the number of 45-year-old or older women, who are at the greatest risk of a thromboembolic event, who use 50 mcg estrogen OCs without good cause. The committee's consumer representative considered this to be a physician education problem. A review of the literature showed no clear, significant increase in the risk of thromboembolic events in women who use 50 mcg OCs. One physician pointed out that continual reduction of the estrogen dose to eliminate the small or nonexistent cardiovascular risks reduces some benefits, especially protection against ovarian and endometrial cancers. Even though the committee did not unanimously agree that 50 mcg estrogen OCs are less safe than OCs with lower estrogen doses, they did agree to recommend more emphasis and prominence on current OC labeling about prescribing the smallest estrogen dose needed to achieve contraceptive efficacy.
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  16. 16

    Triphasics: have they fulfilled their promise? [editorial]

    Weisberg E

    CURRENT THERAPEUTICS. 1992 Jan; 33(1):11-6.

    Triphasic oral contraceptives (OCs) were designed to use the least amount of drugs for the desired effect and to imitate the physiology of the menstrual cycle, resulting in good cycle control and minimal side effects. Yet, studies indicate that triphasic OCs cause only marginally better cycle control than monophasic OCs with reduced frequency of withdrawal bleeding. In fact, the triphasic OCs in Australia do not mimic the normal menstrual cycle. Theoretically, the lowered total steroid doses more gently inhibits the hypothalamic-pituitary function via the absence of a midcycle surge of estradiol and luteinizing hormone and the absence of a rise in luteal progesterone, allowing a more rapid return to functional fertility. 2 triphasic OCs contain the progestogen norethisterone, and the other one contains levonorgestrel. Triphasic OCs appear to have a somewhat lower effect on lipid and carbohydrate metabolism than do current monophasic OCs. Clinicians have not conducted longterm prospective studies on triphasic OCs, so no evidence exists to support the contention that they are less likely to have cardiovascular effects than monophasic OCs. Further, triphasic and monophasic OCs have basically the same effect on blood coagulation factors. OCs have basically the same effect on blood coagulation factors. Many large-scale clinical trials show that the pregnancy rate is around .06. The low dose of levonorgestrel in the beginning of the cycle may reduce effectiveness, however, if women make mistakes. Further, the more complicated packaging of triphasic OCs may make it easier for women to make a mistake. Triphasic OCs may reduce the severity of acne. Most women find triphasic OCs to be quite acceptable, but, in a small group of women, its phasic formulation causes some side effects, including premenstrual syndrome, breast tenderness, excessive bleeding, or painful menstruation.
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  17. 17

    Standardized instructions urged for OCs.

    FDA MEDICAL BULLETIN. 1992 Sep; 22(2):6-7.

    FDA has developed standardized, simplified instructions for all brands of combined estrogen and progestogen oral contraceptives (OCs) to help reduce unplanned pregnancies. FDA asked manufacturers in April to incorporate these changes into patient package inserts as soon as possible. Since current instructions vary significantly from brand to brand, problems can occur when women switch brands and compare instructions. If they become confused, women may either take the pills incorrectly or stop altogether, risking an unwanted pregnancy. In addition to reducing patients' confusion about correct use, the new recommended instructions reflect current research on the effective use of OCs. An important change concerns when women should start taking pills. The new instructions provide only 2 options (current instructions provide more): either start on day 1 of the next normal menstrual cycle ("Day 1 Start") or on the 1st Sunday after the next cycle begins ("Sunday Start"). Although the "Sunday Start" option is popular, the "Day 1 Start" has been shown to be more effective since back-up contraceptive methods are not required for the 1st week, as they are for the "Sunday Start." Other changes in the patient package insert simplify and clarify the instructions when different numbers of pills are missed. Any patient who is unsure about what to do when pills are missed is told to use a back-up method of birth control and to keep taking pills with hormones until she van consult with a health professional. The new labeling also advises women to consult a health professional regarding other methods of contraception if taking a daily pill is a problem. These new directions for patients are for combination pills and do not apply to progestin-only OCs. FDA is still developing new labeling for them. FDA's Fertility and Maternal Health Advisory Committee recommended on FEb. 8, 1991, that the agency ask manufacturers of OCs to make these changes in the patient package insert. (full text)
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  18. 18

    Recommendations for improving instructions for taking oral contraceptives.

    Family Health International [FHI]

    Research Triangle Park, North Carolina, FHI, 1991 Feb 8. [262] p.

    A special notebook for use at a U.S. Food and Drug Administration meeting held February 8, 1991, for the Advisory Committee on Fertility and Maternal Health Drugs, contains draft instructions for oral contraceptive users to be included in the Patient's Package Insert (PPI). There are 9 manufacturers of 56 types of oral contraceptives in the U.S., as well as 26 family planning organizations, with many different sets of directions for use. Particular discrepancies exist in start date, what to do if 1, 2 or more pills are missed, and in related factors such as the design of the package. The suggested instructions are readable by a person with 5-6th grade reading level, are the same for all pills, and resemble those issued by the IPPF and WHO. THe only exception is the difference between 21- and 28-day pill packages. This draft has been pre-tested on a limited basis on 70 users. The rest of the notebook contains sections on advantages and disadvantages of the proposed instructions, a review of relevant biomedical and social literature on pill-taking with excerpted readings, list of manufacturers, types of instructions by manufacturer, bibliography, and contributors. With a 1st-year failure rate as high as 10%, leading to a 10-year failure rate of 40%, it is assumed that if compliance could be improved, the current estimated 250,000 pill failures annually in the U.S. would decrease.
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  19. 19

    Expert meeting on oral contraceptive needs of developing countries.

    Briere R

    [Unpublished] 1984. i, 17 p.

    On March 8, 1984, a group of experts was assembled by the American Public Health Association (APHA) to discuss oral contraceptive (OC) needs of developing countries. The group reviewed current information on OC clinical trial performance, lipid effects, potency/dosage issues, relationship to female reproductive cancers, specific developing country concerns, and various programmatic issues. Particular concern was voiced about the need to try to avoid OC formulation switching in developing country programs since this can have significant adverse effects. Because of logistical difficulties, many developing country programs have difficulty suppling more than 1 OC. Recommendations for minimizing this continuity problem include: 1) providing a single predominant OC for most developing country programs; 2) engaging in multiple-year procurements; and 3) attempting to continue to provide a particular formulation in special circumstances where it has a high proprietary and/or continuity value, (e.g., social marketing programs). Some 30-35 ug estrogen OCs currently available in the US appear to perform in clinical trials at roughly the same general acceptable level as the 50 ug estrogen OCs. Accordingly, there was a general consensus among the group that a single predominant pill should be selected from among these particular 30-35 ug estrogen OCs. At the same time, it was clearly not the group's intent to recommend limiting OCs provided to developing countries to this particular set. Based on concern about human variability, contraceptive efficacy, program continuity, and the desires of developing countries themselves, another list of formulations was also considered suitable. (author's modified)
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  20. 20

    Ortho markets first FDA-approved triphasic pill.

    Contraceptive Technology Update. 1984 Jun; 5(6):69-71.

    Ortho-Novum 7/7/7, the 1st triphasic oral contraceptive to be approved by the FDA (Federal Food and Drug Administration) is now being marketed in the US by the Ortho Pharmaceutical Corporation. The triphasic pill is similar to the biphasic pill as the steriod level is varied during the cycle, but the new triphasic pill more closely follows the normal ovulatory cycle cycle in regard to steriod levels. During days 1-7 of the cycle, the dosage is 0.5 mg of progestogen and 35 mcg of estrogen. Respective doses for days 8-14 are 0.75 mg amd 35 mcg and for days 15-21 they are 1.0 mg and 35 mcg. The total dosage of progestogen for the entire cycle is 15.75 mg. The new pill is associated with less breakthrough bleeding than the biphasic pill and the bleeding pattern is similar to that observed for Ortho 1-35. 2 pregnancies were observed during worldwide clinical trails but only 1 was attributed to product failure. The Pearl Formula failure rate was 0.22 or less. The incidence of side effects was low. The pill is packaged in a 28-day circular dial pack which contains 7 white, 7 light peach, and 7 dark peach pills with an additional 7 placebo pills. Some objectives have been raised concerning the packaging of the product. The pills are very similar in color and patients might find this confusing. Ortho representatives indicated that this should not be a problem if patient are given sufficient counseling.
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  21. 21
    Peer Reviewed

    A five-year clinical trial of levonorgestrel silastic implants (Norplant).

    Diaz S; Pavez M; Miranda P; Robertson DN; Sivin I; Croxatto HB

    Contraception. 1982 May; 25(5):447-56.

    Silastic implants containing the progestin, levonorgestrel, were placed under the skin of the anterior forearm and tested as a longterm contraceptive system in 101 women. During 5 full years of use, no pregnancies occurred. The 5-year continuation rate was 54%. Menstrual irregularities were the most frequent reason for removal during the 1st year when they caused more than 1/2 the terminations. Some of the subjects elected to continue use of the implants beyond 5 years, allowing release rate data to be obtained through 6 years. From the 2nd through 6th year of use, the implants delivered a constant 30 mcg/day of levonorgestrel to the subjects and even after 6 years, 57% of the original steroid content remained in the capsules. Return of fertility following removal was essentially immediate and not related to time of use. Medical reasons for removal were infrequent and no pattern was discernible. (author's modified)
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  22. 22

    Estrogens: a generation of use.

    Pollner F

    American Pharmacy. 1981 Jun; 21(6):38-41.

    There are an estimated 8.4 million women today in the U.S. using combined OCs (oral contraceptives). The estrogen component of OCs can either be mestranol or ethinylestradiol. Formulations with high doses of estrogen are thought to be responsible for most of the side effects related to OCs, i.e. myocardial infarction, venous thrombosis, and thrombotic or hemorrhagic stroke. OC users are 3 times more likely than nonusers to have a fatal heart attack. In women who smoke or who are hypertensive, who have diabetes or high cholesterol levels, or who are in advanced age, the risk increases. High-dose estrogen formulations also seem to increase cholesterol and triglycerides levels, and suppress insulin after about 2 years of use. The use of ampicillin, rifampin or tetracycline may interfere with the contraceptive effect of the formulation. A recent longitudinal study conducted in Walnut Creek, California, concluded that OCs are safe for young, white, middle-class American women. It also noted an increased incidence among users of lung cancer, cervical cancer and malignant melanoma, and attributed these findings to higher rates of smoking, sexual activity, and sun exposure. There are not any postcoital drugs on the market today which are approved by the FDA. DES (diethylstilbestrol) is widely used as an antidote to unprotected intercourse; 25 mg are taken twice a day for 5 days, starting within 72 hours of coitus. The FDA has never been able to induce manufacturers to label the drug noting the severe side effects it can cause. High dosage ethinyl estradiol and conjugated estrogen are also used as postcoital contraceptives. ERT (estrogen replacement therapy) has been proven to increase risk of endometrial cancer, and it does alleviate vasomotor sequelae and vaginal atrophy and dryness. The value of ERT in retarding osteoporosis is still a controversial matter. The FDA and most gynecologists recommend prescribing the lowest dose of estrogen for the shortest time possible in patients for whom alleviation of postmenopausal symptoms by ERT seem warranted. The use of subcutaneous implant of estradiol pellets in the treatment of menopause-related vasomotor symptoms and for contraceptive purposes is currently being investigated.
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  23. 23

    Report of the Committee set up by the Executive of the Irish Medical Association to advise on the hazards and side-effects of ovulation suppressants.

    Irish Medical Association

    Journal of the Irish Medical Association 71(2, Suppl.):1-10. February 17, 1978.

    Approximately 5% of the 48,000 women in the Republic of Ireland who use oral contraceptives were prescribed 1 of the 8 combined preparations which contain 75-100 mcg of estrogen. Since estrogen has been linked to the hazards of oral contraceptive use, all preparations prescribed or marketed in the Republic of Ireland should contain no more than 50 mcg of estrogen. The absolute and relative counterindications to oral contraceptive use are given as is a recommended supervision protocol for current users. Results of studies of cardiovascular mortality associated with oral contraceptive use are summarized, and mortality rates are compared with death rates from various other causes. The association between oral contraceptives and venous thromboembolism and hypertension is discussed as are the effects of this contraceptive method on subsequent fertility and pregnancy. Reasons for discontinuation of this method are explored, and carbohydrate and lipid metabolic changes are outlined. The effects of oral contraceptive use on the liver, the gall bladder, the breasts, the skin, the urogenital system, the eyes and vision, the oral cavity, and the use of certain drugs are reported. It is recommended that physicians receive full information on the contraindications, hazards, and side effects of oral contraceptives and that users be made award of these sequelae and of their symptoms via an explanatory package insert. The 24 preparations currently in use in the Republic of Ireland and their estrogen dosages are listed, and a sample of appropriate user information is given.
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  24. 24

    Comparison of the effects on circulating hormone levels of a conventional and a paper pill oral contraceptive.


    In: Haspels, A.A. and Kay, C.R., eds. International Symposium on Hormonal Contraception. (Proceedings of a Symposium, Utrecht, The Netherlands, September 10, 1977) Amsterdam-Oxford, Excerpta Medica, 1978. p. 89-97

    10 healthy women were studied during a control cycle and during treatment with either a conventional (CP) or paper pill (PP) formulation containing 150 mcg of levonorgestrel plus 30 mcg of ethinylestradiol (Microgynon 30) to test the effects of the PP on pituitary-ovarian function in relation to plasma levels of the exogenous synthetic hormones. Analyses of the natural hormones showed that all control cycles, with 1 exception, exhibited normal menstrual pattern. Data for treated cycles showed that no follicle stimulating hormone (FSH) peaks were evident during any of the treated periods, and in nearly all cases pill withdrawal was followed by a rise in FSH levels. Luteinizing hormone analysis for all treatment periods displayed a similar pattern to that observed for FSH, confirming that ovulation did not occur. Maximal mean treated plasma concentration of levonorgestrel for the CP was 11.3 nmol/1, and for the PP it was 12.68 nmol/1; corresponding values for ethinylestradiol were for the CP 1.53 nmol/1 and for the PP 1.37 nmol/1. There was no statistical difference between the maximal plasma concentrations of the Microgynon 30 components when using either of the 2 differeent formulations (leveonorgestrel, 2P>.55; ethinylestradiol, 2P>.05). 2 short-term plasma profiles from each subject, one at the beginning (Days 2-8) and one at the end (Days 15-21) of the treatment course, showed that plasma titers of levonorgestrel were higher in the 2nd than in the 1st profile, whereas ethinylestradiol levels remained unaffected. The PP formulation compares favorably with the CP.
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  25. 25

    Oral contraceptive patient labeling. Part 310 (new drugs) of Subchapter D (drugs for human use) of Chapter 1 (Food and Drug Administration, Department of Health, Education, and Welfare) of Title 21 (Food and Drugs) of the United States Code of Federal Regulations.

    United States

    International Digest of Health Legislation 27(3): 689. 1976

    Under the terms of this text, manufacturers of oral contraceptives are henceforth required to include in the mandatory patient labelling and the patient brochure a statement that oral contraceptives are of no value in the prevention or treatment of venereal disease. (Full text)
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