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This article is about the decision made by Wyeth-Ayerst to settle lawsuit claims filed by more than 36,000 American women concerning the use of the Norplant contraceptive implant system. The settlement, estimated at $50 million, would end 5 years of litigation involving Norplant. The plaintiff's lawyers claimed that the company downplayed such side effects as irregular menstrual bleeding, nausea, headaches, and depression. Wyeth-Ayerst Laboratories and parent company American Home Products Corp. have denied any wrongdoing and claimed that the side effects were described in the product label. The agreement to settle the Norplant claims were described as purely a business decision by Wyeth-Ayerst North America president Joseph Mahady.
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PMID:Manufacturer moves to settle Norplant claims. 1229 28

This article focuses on issues concerning the prescription and restriction of oral contraceptive (OC) use among smokers and new moms based on the findings from Contraceptive Technology's Update 2000 Contraception Survey involving family planning providers and clinicians. Overall, a majority (72%) of the providers restrict the pills to smokers aged 35-39 years, and 88.6% withhold the pills from smokers aged 40 and above. Providers believed that smoking increases the risk for developing cardiovascular disease; thus, all smokers are warned of that risk and are encouraged and advised to stop smoking. In addition, 42.5% of providers recommend new mothers to begin using the pills 4-6 weeks postpartum; and 45.1% say they start nursing mothers on progestin-only pills 4-6 weeks postpartum. Finally, half of survey participants chose Alesse, a 20 mcg pill, as their top choice for women who have experienced nausea on previous OC formulations.
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PMID:Providing combined OCs: examine special issues. 1229 41

Preliminary results of side effects are reported by 66 physicians of the M.F.P.F. (Mouvement Francais de Planning Familial) on 2026 women taking Stediril, 610 taking Aconcept, and 824 taking Ov 28 for at least 6 months (less for dropouts) since 1969. There were no pregnancies or severe complications except 1 case of jaundice and 2 of thrombosed hemorrhoids. Blood pressure was unchanged in 60-70% of cases, and the graph of these changes, except for a slight increase at "up to 10 mm Hg," was a symmetrical bell curve. Stediril and Ov 28 had identical effects on blood pressure, but the curve for Aconcept was flatter. Weight gain of 1 kg or more was reported in 37% of Stediril users and 42% of Ov 28 users (p less than .05). Other side effects showing significant differences between products were: nausea greater with Ov 28, depression greater with Aconcept, metrorragia greater with Stediril, pelvic pain less with Stediril, headaches less with Ov 28, amenorrhea less with Stediril. This absence of serious side effects was considered the most significant French statisitc published to date on oral contraceptives.
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PMID:[Statistical study of side effects in 3460 women taking combined estrogen-progestagens: preliminary results]. 1230 13

A clinical trial was carried out in Kota Bahru to study the acceptability and effectiveness of the 30 mg ethinylestradiol (EE) and 150 mcg levonorgestrel (LNG) oral contraceptive formulation in a new packaging offered as Rigevidon (R). The 30/50 mcg EE/LNG pill is available in the National Family Planning Program in Malaysia since the mid-1970's as Nordetter (R) and Microgynon 30 (R). A total of 87 women entered the study in 1988 and were followed up for a period of 1 year; however, only 83 cases were used in the analysis. 96.4% of the selected women were Malays, 2.4% were Indians, and 1.2% were Chinese. Additional characteristics include a mean age of 28, 74.7% had 6 years of formal education, and an average parity of 2.8 children with 50.6% having 1-2 children and 12% having 5 or more children. During the last 3 months, 47% of the acceptors had used the oral contraceptive pills previously and 41% had not used any contraceptive methods. 81.9% of the acceptors were using the methods for birth spacing. This small study showed that Rigevidon (R) is an effective and safe oral contraceptive. The gross cumulative continuation rate was 89.5 at 3 months, 86.7 at 6 months, 74.8 at 9 months, and 71.3 at 12 months. Reasons for termination include medical reasons (n=12) such as weight increase, dysmenorrhea, nausea, and headache and personal (n=8) reasons. The most frequently reported side effects include nausea, dizziness, and headache; however, there was a decrease in reported complaints by the end of the 8th month. It was observed that the amount of menstrual flow decreased significantly and complaints of dysmenorrhea reduced from 24.1% to 4.2% at 8 months. The acceptability of this method is high and comparable to the other low dose preparations utilized in the National Program; the continuation rate/100 women for Rigevidon was 74.8 after 9 months of use compared to Gestoden's continuation rate of 72.2. This preparation widens the number of low dose formulation (30 mcg estrogen pills) available to our women in their choice for family planning. (author's modified).
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PMID:Study of rigevidon for oral contraception in a family planning clinic in Kota Bahru, Kelantan. 1231 42

Women who do not have contraindications for oral contraceptives (OCs) and have experienced failure of their contraceptive method or used no contraceptive at all an use emergency postcoital contraceptive pills (ECPs). In fact, if used correctly, they could prevent 1.7 million unplanned pregnancies each year which is 50% lower than such pregnancies which already occur each year. They could also reduce the number of annual induced abortions by 50% from (1.6 million to 800,000). Various postcoital treatments in the US are 2 pills of Ovral within 72 hours of intercourse then 2 more pills 12 hours later and 4 pills of either Lo/Ovral, Nordette, Levlen, Triphasil, or Tri-Levlen followed by 4 more pills 12 hours later. Some gynecologists contend that any low-dose combined OC could be used as an ECP, but not study proves this. Besides, providers who do so risk a malpractice suit, because postcoital contraception is not on OC labels. An attorney suggests using OCs only for an emergency and to document all attempts at informed consent. Many children and clinicians have limited or no knowledge about ECPs. Those health providers who are familiar with them tend not to prescribe them because they fear legal actions. ECP side effects include severe nausea or vomiting, headache, breast tenderness,, dizziness, and fluid retention. These effects are not as great as the health risks of unplanned pregnancies, however. Yet, they are unpleasant enough to discourage repeated ECP use. Use of different methods of determining the number of pregnancies has resulted in broad ECP effectiveness rates (0-96% and 56-94%). Another analysis using combined data from the studies yielding the various results shows the effectiveness rate to be 75%. Anti-abortion groups may object to ECP use, just as they do for RU-486 which has fewer side effects, because one of its mechanisms of preventing pregnancy is it prevents implantation.
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PMID:Postcoital pills could cut unplanned pregnancies by half. 1231 83

Results are presented of a clinical study of Norplant subdermal implants in Colombian adolescents. Implants have been used by 365 adolescents, of whom 174 have completed 2 years of follow-up. Study participants were monitored at months 1, 3, 6, 12, 18, and 24 postinsertion. Among the 174 women, 14% were 14-17 years old and 87% were 17-19. 21% were single, 30% married, and 49% in consensual unions. 38.5% were nulliparous, 56% had 1 child, and 5.7% had 2. 14.3% had a history of abortion. There were no pregnancies in the 2 years. 47.9% of users experienced menstrual irregularities at least once during the 2 years, with 9.3% reporting spotting or staining, 21.2% bleeding, and 19.3% amenorrhea. 6.4% reported nausea, 4.3% headache, 4.3% weight alterations, 2% acne, and 1.4% hair loss. There were 12 removals in the 2 years, 3 each because of menstrual and weight alterations, 2 for headaches, and 4 because of desire for pregnancy. 91.4% declared themselves satisfied with the method. The continuation rate was 93.2% at 2 years. The results suggest that Norplant is a good contraceptive choice for adolescents, but a prolonged study over 5 years is needed to confirm the findings.
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PMID:[Norplant: an effective option for adolescent women. Subdermal implant contraception in adolescent women. Preliminary findings in 174 cases]. 1231 5

This paper outlines methods of therapy utilizing newer combinations of estrogens and progestins. The specific agent and length of treatment depends on the extent of disease, severity of symptoms, presence of infertility and response to pseudopregnancy. Structural formulas for 19 synthetic preparations are shown. Of 36 patients with proven endometriosis in which pseudopregnancy was induced by the use of these newer agents, satisfactory objective in 82%. Pregnancy occurred later in 6 of 10 patients who had previously been infertile and wished to become pregnant. The optimum maintenance dose is 4-6 mg of chlormadinone acetate or ethnodiol diacetate with .2 mg of mestranol and 5-10 mg of megestrol acetate with .2 mg of ethniyl estradiol. Dosage is increased only when break through bleeding occurs. Gain in weight occurred in almost 1/2 of the patients. The decidual reaction was just as great as that produced formerly by large doses of Enovid. In a more recent study 60 patients were treated with Norlestrin, 20 with Lyndiol and 20 with Ovral. Satisfactory objective and subjective remissions were obtained in 89%. Pregnancy has occurred subsequently in 17 to 43 patients who desired pregnancy. All infants have been normal. The optimum maintenance doses seem to be 10-15 mg if Norlestrin, 2.5-5 mg Lyndiol or .5-1 mg of Ovral. The most common side effect was weight gain in 35%. These agents may be used prior to conservative surgery in order to soften areas of fibrotic endometriosis or to pinpoint areas otherwise overlooked. The length of preoperative treatment depends on the extent of disease, 6 weeks being usual. The indication for prolonged pseudopregnancy is recurrent endometriosis following surgery, also proven vaginal endometriosis. Subsequent to conservative surgery, 12 to 24 weeks of therapy are given in order to inhibit ovulation and prevent reactivation of any remaining areas of endometriosis. Tables show commercial combinations and dosage regimens. Nausea, break through bleeding, breast soreness, acne, water retention, isoninia, irritability, lethargy, headaches or development of leiomyomas are side effects to be dealt with by modifying the treatment. Thromboembolic disease has not been a complication in over 500 patients but should be looked for as it has been reported by others. The effect of long-term use of these drugs has been shown to be entirely reversible without subsequent deleterious effects. Severe hepatic disease or previous mammary carcinoma are contraindications. Excessive side effects may necessitate other treatment but the newer drugs reduce this chance. The diagnosis of endometriosis should first be proven.
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PMID:Newer synthetic progestins for the treatment of endometriosis. 1233 29

Oral contraceptive (OCs) users continue to complain of side effects such as headaches, mood swings, and weight gain, and switch pill formulations. Questionnaires for an annual oral contraceptive survey were mailed to subscribers in the May 1992 issue of Contraceptive Technology Update (CTU) 137 of 1600 surveys mailed were returned for a response rate of 8.5%. 64% of the respondents were nurse practitioners, 19% were physicians, 7% were physician assistants, 5% were registered nurses, and 5% were other types of providers. OC users tend to blame headaches, mood swings, or gaining weight on the pills. The CTU survey found that more than 60% of health care providers would advocate switching to a lower-dose estrogen pill or to a progestin-only pill for headaches and mood swings. For weight gain their first choice of treatment would be counseling about life style changes. 50-60% of American women discontinue OCs in the first year, mainly because of side effects such as breakthrough bleeding, headaches, nausea, weight gain, and acne. 89% of respondents said few women had sever, recurring headaches, but should that occur 66% of respondents would change to a lower-dose estrogen pill. Only 9% of respondents would recommend relaxation exercises and analgesics. 67% of respondents would change the pill formulation before suggesting a life style change when patients complain about mood swings. Ortho Novum 7/7/7 was the pill of choice for 61% of survey respondents, and Triphasil was the 2nd choice by 43%. An international group of physicians recommended that manufacturers, physicians, and OC providers take the lead in providing patients with acceptable counseling concerning correct OC use.
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PMID:Experts debate pill switching to combat noncompliance. Special report: annual pill survey. 1234 22

This article answers some questions about use of emergency contraceptive pills (ECP) in the US. It is acceptable to prescribe ECPs over the telephone. ECPs should not be given to women with severe migraine headaches with neurologic impairment. ECPs are acceptable for women who are smokers and over 35 years old, diabetics with vascular disease, women with a history of severe migraine, and women with a benign or malignant liver tumor. Women who seek ECPs over 72 hours after unprotected sexual intercourse could have ECPs, insertion of a Copper T380 IUD, or Ru-486, when available in the US. Lo-Ovral4+4 is the preferred ECP. Ovral2+2 is less often available and tends to cost more. An ECP prescription might indicate Phenergan (25 mg), 4 tablets, taken between 6 and 7 PM, and repeated in 12 hours. Another ECP prescription might indicate Lo-Ovral (21-pill pack), 4 tablets taken one half hour after anti-nausea medication, and repeated in 12 hours. If nausea is severe from the first or second dose of Lo-Ovral, an extra tablet of Phenergan may be taken. For continued contraception, the patient should be prescribed a low-dose pill and not a 50 mcg pill. The most common transition from ECP combined pills to regular oral contraception is to prescribe 4 tablets followed by 4 tablets 12 hours later, and to start a new package of pills the Sunday after menstruation begins. Nonlapsed pill taking involves taking the 4 tablets, followed by 4 tablets in 12 hours, and 1 tablet taken daily for the next 13 days (with backup contraception the first 7 days), and a lapse for 7 days. Nothing needs to be done for vomiting. Women are not likely to abuse this option. It should be widely known and appreciated that mistakes do happen, emergency contraception does work, and women should be aware of ECPs. 98% of women bleed by 21 days after ECP use. There appears to be no increased risk of birth defects among pill users who become pregnant.
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PMID:10 common questions on emergency contraception. 1234 14

Emergency contraception may avoid pregnancy after unprotected intercourse or when regular contraceptive measures fail. Levonorgestrel, a synthetic gestagen, is recommended for emergency contraception as a single 1.5-mg dose or, alternatively, two 0.75-mg doses taken 12 h apart. Its efficacy is moderate, preventing about 80% of pregnancies. Efficacy is higher the earlier after unprotected intercourse the drug is taken, but it may be administered up to 5 days post-coitum. Tolerance is similar to, or better than, those of other oral emergency contraceptives. Adverse effects include nausea, vomiting, headache, breast tenderness and transient alteration of menstrual bleeding pattern. It is not known whether levonogestrel increases the risk of ectopic pregnancy when the treatment fails. Its use as an ongoing contraceptive method is discouraged. When given before the preovulatory LH peak, levonorgestrel blocks or delays ovulation. It may also affect sperm migration in the female reproductive tract and have an effect on fertilization. Although it has been often postulated, there is no evidence for an anti-implantatory effect. Acquaintance with the method is quite variable among different societies, but it remains underutilized even where it is well known. Advance provision of the drug has been proposed as a way to promote its use. In clinical trials, advance provision did not adversely modify sexual or regular contraceptive behavior, but it did not reduce pregnancy or abortion rate either. Therefore, emergency contraception with levonorgestrel should be regarded as a backup method which is not a substitute for the continued use of more effective contraceptive methods.
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PMID:[Emergency contraception with levonorgestrel]. 1805 Dec 34


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