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IUDs: an appropriate contraceptive for many women. DIU: un anticonceptivo apropiado para muchas mujeres.
Population Reports. Series B: Intrauterine Devices. 1982 Jul; (4):B101-B135.This discussion of IUDs covers the following: usage shifts to copper IUDs; issues for the 1980s; comparing the Lippes Loop and copper IUDs; life span of copper devices; steroid releasing IUDs; donor agency supplies; types of devices used; insertion and removal (timing of interval insertion, postpartum insertion, postabortion insertion, postcoital insertion, measuring the uterus, removal, and insertion by nurse midwives and paramedicals); bleeding (risk of anemia, limited bleeding); infection (mechanisms of infection, prevention, treatment, actinomyces); pregnancy (uterine pregnancies, ectopic pregnancies, differences among devices, and subsequent fertility); product and packaging issues (manufacture in developing countries, prices, bulk and individual packaging, methods of sterilizing IUDs, and storage). At this time about 60 million women worldwide are using IUDs, including over 40 million in China. In recent years the total number of users has remained relatively stable. The life table event rates per 100 women, by which IUDs are usually evaluated, are approximately as follows after 1 year of use in large, multicenter studies: pregnancy, 0.5-5; expulsion, 5-15; removal for bleeding/pain (5-15); removal for other medical reasons, 3-9; and removel for personal reasons, 1-6. Continuation rates 1 year after insertion tend to range from 50-85%, high rates for a reversible mothed. Some shift in usage occurred in the late 1970s from unmedicated Lippes Loop to copper releasing IUDs and to a lesser extent to IUDs that release progestins into the uterine cavity. Copper devices now have captured much of the market in the US and Western europe and amount to about 2/3 of the supplies provided by donor agencies to many developing countries. During the 1980s attention should probably focus less on the search for an ideal device and more on the need for family planning programs to identify suitable candidates for IUDs, encourage better health service support for IUD insertion and follow-up, and the newer IUDs more widely available to individuals and national programs. In most developing countries the great majority of IUDs are supplied by various national and international donor agencies that purchase large quantities at the lowest possible price and ship them to government and private programs. No data are available on the number of each type of IUD currently in use. Proper insertion of an IUD is important. Insertion can affect all major events that determine success. While there are several different techniques for inserting IUDs, with each the skill of the operator is critical. Recent studies fo about 10,000 women show that there is no one preferable time for insertion.
Fdc Reports. Drugs and Cosmetics. 1981 Jul 11; 45(28):T and G-1.Spermicide product warning for use by women who may be pregnant is being considered by FDA, Deputy Com. Mark Novitch noted in a June 29 letter to Rep. Weiss (D-NY). In response to Weiss' inquiry about the potential teratogenicity of nonoxynol-9, in the VLI Today 24-hour contraceptive sponge, Novitch said that evidence indicates that the ingredient "is not teratogenic." Novitch added that "we are, however, currently considering a special warning concerning the use of any spermicides by women who suspect they may be pregnant." Novitch pointed out that FDA "has previously considered the possible modes by which spermicides could have a teratogenic effect, if such an effect exists. These modes include an effect on the developing ovum, sperm passing through a sublethal concentration of spermicide, fertilized ovum, and developing embryo." He added, however that "while all could perhaps be regarded as theoretically possible modes of teratogenesis, it is not easy to see how effects on the sperm would lead to teratogenicity, a developmental, not genetic, abnormality." Novitch's explanation of the agency's overall thinking regarding the use of spermicides in women who may be pregnant was in response to a specific question from Weiss on the safety of the Today product. Weiss has asked FDA 23 separate inquiries concerning the safety of Today ("The Pink Sheet" July 4, p.8). In another question to FDA on Today, Weiss maintained that the product is potentially carcinogenic, mutagenic, and teratogenic. He asked why the agency did not require that consumers of the OTC product be advised of the risks in the package insert. Novitch replied that FDA does "not feel that the product is carcinogenic and mutagenic," but he repeated that the agency is considering a teratogenicity statement for all spermicidal products. (full text)
Federal Register. 1979 Jun 26; 44(124):37434-67.The final ruling on the required format for physician labeling of prescription drugs for human use is presented. The Food and Drug Administration (FDA) intends, through the act, to improve prescription drug labeling by establishing standards that will bring all labeling up to the level of the better labeling currently available. Comments on the proposed act were solicited during the summer of 1975. 97 responses were received from physicians, professional societies, drug manufacturers, trade associations, individual consumers, and consumer groups. General comments proposed 35 changes or objections to the act, e.g., that the act was an invalid invasion by the federal government in the field of medicine, and that it would increase the cost of prescription drugs because of the expenses incurred by manufacturers in rewriting the labeling. Comments on specific requirements and format of labeling were received concerning the following sections of the act: the required descriptive informtion necessary for the safe and effective use of the drug, information on clinical pharmacology, indications and usage, contraindications, warnings, precautious (especially informtion concerning use during pregnancy), adverse reactions, overdosage, dosage and administration, how supplied, animal pharmacology and/or animal toxicology, and clinical studies and references. Additional comments on full disclosure, package inserts, and advertisements are reviewed. The presentation concludes with the final amendments to the proposal concerning the content and format of prescription drug labeling.
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)
Irvine, California, VLI Corporation, Professional Relations Department, 1983 Jun. 9 p.A new vaginal contraceptive sponge (Today) successfully completed the US Food and Drug Administration NEW DRUG review process for safety and efficacy on April 1, 1983. The Today sponge will be marketed as an over-the-counter drug. The product consists of a resilient, hydrophilic, polyurethane foam sponge impregnated during manufacture with nonoxynol-9 (N-9), a spermicide in use worldwide for over 20 years. N-9 has been classified as safe and effective by the FDA Advisory Review Panel on OTC Vaginal Contraceptives. Contraception with the Today sponge occurs by: 1) spermicidal action of N-9, 2) sperm absorption into the sponge, and 3) blockage of the cervix. The principal advantage of the Today contraceptive sponge, aside from being available without prescription, is that it separates the act of contraception from that of intercourse, thus permitting for the 1st time, sexual spontaneity with a vaginal contraceptive. Multiple coital episodes are possible with a single sponge. Preclinical USP toxicity studies, mutagenicity assays, allergenic response tests, microbiological studies, and human clinical trials conclusively show no evidence of a significant health risk. The product was found in laboratory tests to be hostile to the growth of Staphylococcus aureas, suspected in the etiology of Toxic Shock Syndrome (TSS). Clinical trials with the Today contraceptive sponge, however, were not large enough to assess the risk of developing TSS. Particular attention has been directed to demonstrating safety with respect to carcinogenicity and mutagenicity. Assays for monomers have continually shown the finished product sponge and the polymeric sponge alone to lack any concerns in this area. These assays are conducted on a continuing basis through a formal stability program now in its 3rd year. This stability program includes accelerated testing at both high and low temperatures for up to 3 months, which has confirmed a lack of product degradation. Further, and most significantly, the product has been subjected to a stringent series of carcinogenicity and mutagenicity screens consisting of both the Ames Salmonella Mutagenicity Test and the Mouse Lymphoma Forward Mutation Assay. These tests have been conducted by both Huntingdon Research Center and Litton Bionetics, and have been successfully passed by the Today sponge in every instance. Phase I trials beginning in 1977 (100 women) demonstrated general acceptability and led to improvements in contraceptive capability. Phase 2 clinical trials beginning in 1978 (400 women) produced a cumulative 6-month life-table pregnancy rate of 5.98/100 women; the protocol called for 1 month use of a single sponge with reuse/washing permitted for a maximum of 10 washings. Phase 3 randomized comparative trials (1600 women) began in 1979 and are ongoing internationally and in the US. This protocol calls for a single sponge use for up to 48 hours wear time. Data to date indicate that sponge effectiveness is in the same range as other vaginal contraceptives. Analysis of the outcome of pregnancies during and after use of the sponge indicates no teratologic or embryologic effects. Of the 719 women in the US studies, 1.7% discontinued because of itching, irritation, rash; 1.9% discontinued because of allergic reactions. These results are consistent with the normal allergenic reactions experienced with the use of N-9. Since insufficient numbers of women in the Phase 3 studies chose to use the sponge for a full 48 hour period, statistical analysis of effectiveness data permits only a single day use recommendation. Thus, in the US, users are instructed to rely on the sponge for pregnancy prevention no longer than 24 hours and to leave the sponge in place at least 6 hours after the last episode of coitus. (author's modified)