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Contraception. 2014 Jul; 90(1):1-3.In 2013, European authorities’ changes to the label for NorLevo 1.5, an emergency contraceptive pill, are of compelling interest to reproductive health advocates and clinicians. First, they approved a new description of the product’s mechanism of action, and the second is a warning that it may not work for heavier women. Although these changes were approved simultaneously, the evidence base for these two changes differs in substantial ways. The authors of this commentary argue that the publicly-available evidence (in the form of peer-reviewed studies) around the mechanism of action of emergency contraception is sufficient to support this label change, while more evidence is desired to clarify the relationship between efficacy and weight. [excerpt] Copyright © 2014 Elsevier Inc. All rights reserved.
Mother Jones. 2013 Nov 25;  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)
CMAJ. 2014 Jan 7; 186(1):E21-2.Add to my documents.
CMAJ. 2014 Jan 7; 186(1):E15-6.Add to my documents.
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.
Arlington, Virginia, JSI, DELIVER, 2009.  p. (USAID Contract No. GPO-I-01-06-00007-00)USAID's Public Health Product Catalog 2010 is a catalog of condoms and contraceptives provided by USAID.
Contraception Report. 1999 Jan; 9(6): p..For the first time in the United States, emergency contraceptive pills carrying Food and Drug Administration (FDA)-approved labeling are commercially available. The specially-packaged product, the PREVEN Emergency Contraceptive Kit, contains four pills of a high-dose combination of ethinyl estradiol and levonorgestrel oral contraceptives (OCs). The product is for women who have had unprotected sexual intercourse within 72 hours of use who do not want to become pregnant. The high-dose method has been available in some other countries since the 1970s. Globally, the method is known as the Yuzpe regimen, postcoital contraception or the "morning-after pill." The regimen has been marketed in Europe since 1984. While some OCs have been used "off-label" for emergency contraception, routine use has been limited in the US. A survey commissioned by the Henry J. Kaiser Family Foundation of 2,002 US adults found that only 1% said they or their partners had used emergency contraception. A second survey of 307 obstetrician-gynecologists found that although about 70% said they had prescribed emergency contraception within the last year, 77% did so infrequently--five or fewer times. (excerpt)
Contraceptive Technology Update. 2004 Feb; 25(2): p..This month may well mark a milestone in women’s health if the Food and Drug Administration (FDA) follows the recommendation of two of its expert advisory committees to approve the over-the-counter (OTC) sale of Plan B, the levonorgestrel-only emergency contraceptive (EC). In a joint meeting of the FDA’s Reproductive Health Drugs and Nonprescription Drugs Advisory committees, members voted 23 to 4 to recommend OTC sale of the drug. The final decision rests with the FDA’s commissioner, Mark McClellan, MD, MPH. While the FDA doesn’t always follow its advisory panels’ recommendations, it would be “surprising” if it did not in this case, says James Trussell, PhD, professor of economics and public affairs and director of the Office of Population Research at Princeton (NJ) University. “There wasn’t much opposition, and there was considerable support” for making the EC drug available on retail pharmacy shelves, says Trussell, who was a member of the FDA joint committee. (excerpt)
PLANNED PARENTHOOD IN EUROPE. 1995 Aug; 24(2):23-4.In Hungary, an important form of emergency contraception (EC) is the pill containing 0.75 mg levonorgestrel, which is marketed by Gedeon Richter under the name Postinor in four-pill packages. Women are instructed to take one pill within an hour of any unprotected act of intercourse, up to four pills per month. The nature of the administration requires that women be in possession of the pills before they need them, and, while Postinor is marketed as an EC, the target market is young, unmarried women who experience infrequent intercourse. When it was first offered a decade ago, Postinor gained widespread use in place of contraception. The product was overused and there was a backlash in the medical community. Thus, the manufacturer changed its packaging instructions and removed the original 10-pill package from the market. While the price of the drug is considered prohibitive for use by adolescents, more than three million pills were sold in the past three years in Hungary and more than 60 million pills were sold in over 20 countries. Clinical studies show a failure rate of less than 1% and relatively few side effects (10-20% nausea and 20-40% bleeding) if not more than four pills per month are used. The World Health Organization is currently conducting trials to compare use of Postinor with the Yuzpe method. Results of these trials will be available in 1996.
JOURNAL OF FAMILY PRACTICE. 1992 Sep; 35(3):249.Dr. Reynolds raises concerns regarding the Norplant packaging system. The surgical specialists in eastern North Carolina performing training programs for Wyeth did initially teach physicians to place the sterile Norplant capsules onto the nonsterile tray during insertion. Some of our faculty were trained in this technique, and at least 1 of the 3 insertions resulting in skin complications was performed in this manner. When the letter by Reynolds and Weber was published in JAMA in November of 1991, the wyeth surgical specialist wrote to 11 physicians in this area informing us to stop using the Norplant tray as part of the operative field. I am intrigued by Dr. Lawless's description of a recent skin complication following the insertion of the Norplant contraception system. She indicated that adequate depth of insertion and proper sterile technique were assured in the patient who developed the skin complication. After witnessing several superficial insertions recently performed by surgical specialists outside our University center, I am confident that we also correctly placed the subdermal implants. I emphasize that we do not know the cause of the reported skin complications. it is unclear whether epinephrine played a significant role. Darney reported in the May issue of the Journal that a large number of insertions performed with epinephrine failed to show any complications. We have recently performed 100 procedures without epinephrine and have failed to observe any skin problems. Dr. Lawless's patient was anesthetized with xylocaine that included epinephrine. Wyeth apparently has been aware of many reports of skin complications. It is unclear why these complications have not been more widely publicized to physicians. With increased physician reporting, it is hoped that the cause of these problems may be identified and corrected. (full text) (2 references cited in original document)
JOURNAL OF FAMILY PRACTICE. 1992 Sep; 35(3):249.Zuber, DeWitt, and Patton recently reported 3 cases of skin damage after implantation of Norplant. One plausible explanation for the skin damage would be infection or granulomatous foreign body reaction if unclean and nonsterile technique was during the insertion procedure. As I have previously reported, some manufacturer-sponsored hands-on training sessions for inserting Norplant have demonstrated improper use of the nonsterile white plastic packaging tray as a sterile field. As a result of discussions that I have had with the manufacturer and the FDA, a prominent "Nonsterile Tray" label has been placed on the clear plastic cover of the Norplant System. Under the cover and in the wells of the white plastic tray are 15 separate items that must be unwrapped and placed in a side table sterile field before the insertion can proceed. Despite widespread dissatisfaction with this inefficient packaging, Wyeth-Ayerst has refused to repackage the Norplant system in the fashion of an "open-it-once" sterile tray. (full text) (2 references cited in original document)
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)
Contraception. 1981 Oct; 24(4):323-39.A contraceptive vaginal ring containing levonorgestrel and estradiol was designed in which the drug is located in a 0.15 mm layer beneath a 0.25 mm overcoat at the ring's surface which controls the rate of steroid release. This design has been termed the "shell" ring. In vitro studies were carried out on the shell ring and also on 2 types of rings of earlier design, a homogenous ring and a shell ring without the rate-controlling overcoat. Levonorgestrel and estradiol were released in vitro at a constant rate of about 500 mcg/day and 300 mcg/day respectively, from shell rings of 9.2 mm cross-sectional diameter and 58 mm overall diameter. In the other 2 types of rings, a burst of steroid release was seen followed by a rapid fall in diffusion rates. Individual shell rings were used in clinical trials for 6 or 7 consecutive 21 day cycles with a 7 day nonuse interval between cycles. At the end of the study, they were returned to allow analysis and calculation of average steroid loss in vivo. In vivo, rings of 58 mm diameter were found to release levonorgestrel and estradiol at rates of 293 + or - 54 mcg/day and 183 + or - 34 mcg/day, respectively. Rings of 50 mm diameter had levonorgestrel and estradiol release rates of 252 + or - 34 mcg/day and 152 + or - 21 mcg/day, respectively. The release characteristics of the shell ring are such that it is expected to find a role in fertility control. All the studies reported in this issue of Contraception have used the same design of shell ring. (author's)
Washington, D.C., American Public Health Association, 1977. 75 p. (APHA Assign. No. 1100-079)In order to evaluate and assess basic progress and problems in the implementation of the AID contract with Syntex Laboratories for a Commercial Retail Sales(CRS) project in Tunisia, various specific tasks and the overtly specific schedules are divided into 6 broad categories: 1) the dissemination of better medical information on oral contraceptives and condoms; 2) publicizing of the products directly to consumers by advertising through mass media, point of purchase, and other advertising promotional methods; 3) improvement of the current commercial system of distributing oral contraceptives and condoms through pharmacies; 4) extension of availability of both products nationwide by initiating distribution through general retail outlets; 5) establishment of a retail sale price affordable by the poor and with sufficient profit incentive for all merchants along the distribution chain; and 6) attainment of an economically self-sustaining system. It is believed that too much emphasis is put on developing a comprehensive, activity-specific plan with a rigid, artificial schedule, and that it is more productive to focus on practical expectations for the program within the general areas of program action. This review of progress to date is therefore centered on actual achievements and obstacles within the 6 program areas than on the detailed requirements and deadlines in both the contract and the marketing plan. Recommendations are made in the following areas: 1) general and basic; 2) administrative; 3) programmatic--information and advertising; 4) programmatic--distribution; and 5) programmatic--pricing. The following appendices are included: 1) evaluation of Tunisian Program, July 1975; 2) GOT documents announcing decisions to restrict importation of oral contraceptives to 3 brands, July 1977; 3) letter exchange between GOT and USAID approving contract AID/pha-C-1143; 4) letters of John Thomas and Robert Smith, 1977; 5) initial package designs for project commodities; 6) report from Institute Superior de Gestion on brand name choices; 7) proposed Advisory Board; 8) examples of information/ education materials produced by ONPEP; 9) list of persons contacted during Nov. 5-14 visit to Tunisia; 10) program statistics, 1971-76; and 11) scope of work for evaluation of CRS project in Tunisia.
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. 89-9710 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.