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  1. 1

    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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  2. 2

    Guidelines for the use of antiretroviral agents in pediatric HIV infection. Supplement I: Pediatric antiretroviral drug information.

    Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children

    [Unpublished] 2005 Mar 24. 34 p.

    In order to successfully suppress HIV viral replication without disruption of normal cellular function, it is essential to target specific components unique to the virus. Theoretically, antiretroviral agents that target the initial stages of the viral replicative cycle (prior to provirus formation), should prevent primary infection of cells, yet be ineffective in cells that have already integrated virus and drugs that inhibit steps after viral integration should block new virus production by virally infected cells. Currently FDA approved antiretroviral medications include fusion inhibitors, which prevent viral entry; reverse transcriptase inhibitors (nucleoside, nucleotide, and nonnucleoside), which act at the early stage of replication; and inhibitors of viral protease, which work in the later stage after viral integration. Fusion inhibitors are the newest class of antiretroviral drugs, and act by inhibiting binding or fusion of HIV to target host cells. The NRTIs are potent inhibitors of the HIV reverse transcriptase enzyme, which is responsible for the reverse transcription of viral RNA into DNA; this process occurs prior to integration of viral DNA into the chromosomes of the host cell. The NRTIs require intracellular phosphorylation to their active forms by cellular kinases. (excerpt)
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  3. 3

    Report to Congress pursuant to the Federal Cigarette Labeling and Advertising Act for the years 1982-1983.

    United States. Federal Trade Commission [FTC]

    [Unpublished] 1985 Jun. 50 p.

    This report is the most recent in a series of reports on cigarette advertising that the Federal Trade Commission (FTC) has submitted annually to the US Congress since 1967 pursuant to the Federal Cigarette Labeling and Advertising Act. On September 26, 1984, Congress passed and on October 12, 1984, the President signed into law the Comprehensive Smoking Education Act. This Act amends the Federal Cigarette Labeling and Advertising Act. It provides for establishment of a Committee on Smoking and Health in the Department of Health and Human Services to coordinate federal and private efforts in educating the public on the adverse health effects of smoking. Additionally, Section 4 of the Act amends the Federal Cigarette Labeling and Advertising Act by requiring all manufacturers and importers to display on a quarterly rotating basis 4 specified health warnings on all cigarette packages and advertisements other than outdoor billboards. In 1983 the Commission sued successfully in the US District Court for the District of Columbia to enjoin Brown & Williamson Tobacco Company from advertising its Barclay cigarettes as a 1 mg "tar" cigarette or from using any "tar" number not specifically approved by the FTC. Brown & Williamson appealed, and the argument was heard on October 2, 1984, but no decision has been issued. Advertising expenditures for US cigarette manufacturers reached nearly $2 billion in 1982. By the end of 1983, the figure was almost $2.65 billion. Cigarette manufacturers led all other national advertisers in newspaper advertising and ranked second in magazine advertising. Associating smoking with high-style living, economic and social success, and healthy activities were the prevailing messages sent by the industry to consumers. In 1985, there was a marked increase in the market share of generic brands that were first introduced in late 1982. In 1983, R.J. Reynolds introduced the 25-cigarette pack. There have been numerous efforts to reformulate brands that failed achieve sales success when first introduced but were regarded positively in market surveys. Cigarettes sales are believed to have been affected by the increased cost of cigarettes due to an increased cost of cigarettes due to an increase in the excise tax and the continued reports on the health consequences associated with both active and passive smoking. Some of the major findings of the Surgeon General about the health consequences of smoking since initial consideration by the Congress of the rotational health warning legislation are summarized. The Surgeon General's reports on the health consequences of smoking have provided a significant stimulus to make the public aware of the adverse effects of tobacco usage. The most recent of these have dealt particularly with with the impact of cigarette smoking on cancer, chronic obstructive lung disease, and coronary heart disease. A table shows the totals of US cigarettes sold for the years 1963 and 1983.
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  4. 4

    Improving compliance with oral contraceptive regimens.

    Segal AE

    NP NEWS. 1994 Sep-Oct; 2(5):25.

    20% of unplanned pregnancies in the US result from oral contraceptive users' failure to take their pills on a regular basis. More than 50% of all women who take contraceptives report some side effects. Women who have side effects are more likely to miss pills. Missing pills, however, increases a woman's likelihood of having side effects. Half of all women leave their health care practitioner wanting more information about their contraceptive drug. Of the women who want more information, more than half discontinue their drug regimen. To increase compliance with an oral contraceptive regimen, health care practitioners can talk more extensively to each woman, providing as much information as wanted during the initial consultation, and inviting calls if more information is desired later. Women also need to establish a routine of taking their pills, preferably in the morning. Dr. Michael Rosenberg of the University of North Carolina is currently studying the effect of packaging upon the rate of compliance with an oral contraceptive routine. It is thought that well-designed packages as well as appropriate educational materials can help women to take their pills consistently and correctly. The author calls attention to the Wyeth-Ayerst Triphasil Cycle Pack as a highly compact package which lets a woman see instantly if she has taken her daily pill.
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  5. 5

    Patient education and understanding: a critical review.

    Killick SR

    ADVANCES IN CONTRACEPTION. 1992 Oct; 8 Suppl 1:57-65.

    All women in the UK have access to family planning (FP) services via general practitioners (GPs), fee paying clinics, and National Health Service FP clinics. FP services are adequately publicized and open late in the evening. They consider patient education as high priority. Nevertheless recent studies indicate that patient knowledge of oral contraceptives (OCs) is lower than expected. Most large clinical trials reveal OC failure rates are about 3% yet subjects tend to be married women who have the lowest failure rates. Rates from clinics are up to 6%. Among US adolescents and women from developing countries, failure rates may reach 13-20%. Despite comparable rates of sexual activity among adolescents, pregnancy rates among European adolescents are much lower than those among US adolescents (50% lower in Sweden and 85% in the Netherlands). Research in family planning clinics in London show that many women do not even have basic knowledge about OCs, but they had greater knowledge than women who received counseling at GPs offices. Adolescents of lower socioeconomic status who fear real or perceived side effects, use the low dose OCs, and served by a poor quality delivery system which provides little or no educational counseling are at highest risk of poor OC compliance and OC failure. Manufactures should include start days an sequence and package OCs in a small package. After identifying what patients are at risk of OC failure, physicians must realize that people learn in a safe and calm environment and by doing. They can only remember 3 messages/session. Physicians need to pay attention to the patient, to assume nothing, and to hand the patient written facts about OCs. Education comes down to teaching facts, teaching skills, and answering questions. The most powerful means of patient education is the mass media.
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  6. 6
    Peer Reviewed

    To prescribe or not to prescribe: on the regulation of pharmaceuticals in less developed countries.

    Hammer JS

    Social Science and Medicine. 1992 May; 34(9):959-64.

    Insufficient information contributes to failure in markets. Government officials also use it to justify intervention in the health sector in the developing countries. Further, in these countries,health care workers have misused pharmaceuticals considerable as well as make improper diagnoses. Moreover both health practitioners and the general public do not always follow instructions on drug use. A shortage of information on appropriate use may indeed cause these problems. A staff member of the World Bank proposes a methodology to use to balance 2 competing risks. Either public health officials allow drugs to be available to consumers over the counter or they require a prescription from a licensed health professional. The risks include obvious diagnostic errors made my consumers untrained in medicine and patients not receiving needed, potentially life saving, drugs. Since there is a shortage of medical personnel in most developing countries, people face considerable obstacles (e.g., travel time and expense) when it comes time to go to a licensed medical facility. The proposed methodology to evaluate the tradeoff between the 2 risks involves looking at the problems as one of determining the value of a more accurate diagnosis through the intervention of a skilled professional as a specific and costly mechanism for acquiring an accurate diagnosis. The article applies the model to illustrative examples to identify the information to answer the regulatory issue question. Further the model also allows public health policy makers to determine the appropriate level of training needed for medical professionals and to evaluate projects which improve public access to information on the use of drugs.
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  7. 7

    Influence of oral contraceptives on body temperature [letter]

    Meyboom RH

    BMJ. British Medical Journal. 1991 Apr 27; 302(6783):1025.

    Dr R H B Meyboom (Netherlands Pharmacovigilance Centre, PO Box 5406, 2280 HK Rijswijk, The Netherlands) writes: 1 of the physiological effects of progesterone is a slight rise in body temperature, up to 0.5 degrees Celsius. Midcycle temperature rise may be used as evidence of ovulation and the formation of a corpus luteum. Although progestagens are a basic constituent of oral contraceptives (OCs), the possibility of an influence on temperature is not mentioned in the usual sources of information on side effects. A recent case report to The Netherlands Pharmacovigilance Centre described a 35 year old woman with longstanding rise in body temperature of about 0.5 degrees Celsius, which in the evening reached subfebrile values up to 38 degrees Celsius, in suspected association with Microgynon 30 (levonorgestrel 150 mcg, ethinyl estradiol 30 mcg). No medical cause was found and the course of the temperature after stopping and during rechallenge, as established by daily rectal assessment of morning temperature, was consistent with an effect of the contraceptive agent. Although the influence of progesterone on temperature is well known, there is a remarkable paucity of data in current physiology textbooks concerning this effect. With regard to OCs, only 1 reference was found in the medical literature, but without quantification and comment. A body temperature raised by 0.5 degrees Celsius may be mistaken for a subfebrile temperature and may be a cause of unnecessary concern and medical investigations. More information on the influence of progestagens on temperature is needed. The product information of all OCs containing a progestogen should mention the possibility of a slight rise in body temperature. (full text) (9 references cited in original document)
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  8. 8
    Peer Reviewed

    Clinical experience with triphasic oral contraceptive (Triquilar) in 527 women in China.

    Weng LJ; Xu D; Zheng HZ; Zhang JY; Sang GW; Qian LJ

    CONTRACEPTION. 1991 Mar; 43(3):263-71.

    From October 1987-May 1989, a total number of 527 women completed a total of 6291 treatment cycles in 6 centers in China for the study of a triphasic oral contraceptive (OC), Triquilar. The mean age of the subjects was 30.21 +or- 2.84 years. There were 7 pregnancies during the study period. Among them, 5 were patient failures due to a missed pill or incorrect dosage; 1 had taken barbiturates along with Triquilar. Only 1 woman became pregnancy in the 11th treatment cycle without any discernible reason. In most cases, menstrual flow decreased and dysmenorrhea improved as treatment continued. Of the total treatment cycles, the incidence of missed withdrawal bleeding was 0.25%, spotting 0.97%, and breakthrough bleeding 0.48%. Nausea and vomiting were the most common side effects and accounted for 6.4% of the total treatment cycles. This was followed by breast tenderness (3.7%), dizziness (2.4%), and headache (1.6%). Most of these occurred during the 1st few cycles and were alleviated later. By the end of 1 year, the total dropout was 64 cases. The reasons for discontinuation of treatment were: pregnancy 1.33/100 women, menstrual disturbances 0.76, side effects 3.80, other medical reasons 2.09, and personal reasons 4.18. Results confirm that Triquilar is an effective OC with good cycle control and low incidence of side effects. No serious reaction has been reported. It has been well accepted by the Chinese women. However, due to the low dosage of steroids, it is of utmost importance to avoid errors in its use. Not only should the package of the drug carry conspicuous warnings, but also detailed instructions should be given to the women in order to obtain the desired efficacy. (author's)
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  9. 9

    Oral contraceptives and breast cancer: a consumer toxic tort.

    Brannigan V

    JOURNAL OF CONSUMER POLICY. 1990 Jun; 13(2):201-14.

    Recent epidemiological studies show a correlation estrogen based oral contraceptives and breast cancer. In certain groups, the studies indicate a 2-4-fold increase in breast cancer. The epidemiological data are bolstered by a well-accepted connection between estrogens and breast cancer. The unique status of OCs and the special problem of breast cancer make this 1 of the 1st viable consumer "toxic tort" cases. Consumers in the US who use OCs and develop breast cancer should be able to recover damages based on a theory of failure to warn. (author's) (summary in GER)
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  10. 10

    Public version: Federal Trade Commission staff report on the cigarette advertising investigation.

    Myers ML; Iscoe C; Jennings C; Lenox W; Minsky E; Sacks A

    [Washington, D.C.], Federal Trade Commission, 1981 May. [308] p.

    In its present investigation the Federal Trade Commission staff focused on 5 major issues: in light of the substantial growth of medical information in recent years, what are the known health consequences of smoking; what health information does cigarette advertising promotion contain about the nature, probability, and severity of the dangers of smoking; does the public already know these facts or does a substantial portion of the population lack knowledge of or hold false beliefs about the dangers of smoking; is the current warning effective in alerting the public about the health hazards of smoking; and is remedial action necessary. The issues presented by the current investigation emerge as more complex than when the Commission initially took action in 1964. In 1964, the Surgeon General had published his 1st comprehensive report on smoking and health, and cigarette packages and advertisements contained no health warnings. Similarly, in 1969 and 1971, cigarette advertisements contained no health warnings. The past efforts on the part of the Commission along with the efforts of Congress and other governmental agencies and private organizations to increase the amount of health information available to consumers have had an important impact. Many more consumers now are aware that smoking is hazardous to their health than in 1964. The percentage of Americans who smoke cigarettes has declined significantly over the same time period, and a substantially larger number of those who do smoke now smoke cigarettes with lower levels of "tar" and nicotine. Yet, many consumers do not know enough about the health effects of smoking to know how dangerous smoking is and desire more information about the specific hazards of smoking. Over 30% of the public remains unaware of the relationship between smoking and heart disease. Nearly 50% of all women do not know that smoking during pregnancy increases the risk of stillbirth and miscarriage. Approximately 30% of those polled do not know about the relationship between smoking, oral contraceptives, and the risk of heart attack. Many more consumers seriously underestimate the severity or increased risk of dying from the smoking-related illnesses. The health consequences of smoking are summarized in detail as are recommendations. Commission staff believes the following actions are likely to be most effective: additional funding for expanded educational efforts, such as public service announcements; changing the shape and increasing the size of the current warning; and replacing the current warning with a system of short rotational warnings. Expanded educational efforts would reach millions of consumers.
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  11. 11

    Consumer warnings for oral contraceptives: a new exception to the prescription drug rule.

    Schwartz TM

    FOOD DRUG COSMETIC LAW JOURNAL. 1986 Jul; 41(3):241-56.

    Courts in the US uniformly have held until recently that the duty of drug manufacturers to warn of risks associated with prescription drugs runs only to physicians and not to consumers. The rule is based on the premise that the consumer is protected when the manufacturer provides an adequate warning to the physician, for the physician acts as a "learned intermediary" between the drug manufacturer and patient. Now, several courts have held that drug manufacturers have a duty to warn consumers directly of the dangers associated with the use of oral contraceptives (OCs). In identifying this duty, these courts have pointed out that OCs differ from most other prescription drugs: unlike most prescriptive drugs, OCs are "elective" drugs that the patient herself largely decides whether or not to use, and the "learned intermediary" doctrine thus is not as applicable in these cases; and Food and Drug Administration (FDA) regulations require consumer warnings for OCs. The remainder of this article discusses further the prescription drug rule, mass immunization cases, FDA regulation, OC cases, the adequacy of the warnings, and prospects for further exceptions to prescription drug rule. Until recently the only exception to the prescription drug rule had been carved out by a trilogy of cases involving polio vaccines -- Davis v Wyeth Laboratories, Reyes v. Wyeth Laboratories, and Givens v. Lederle. Beginning in the late 1960s, FDA began to issue regulations that challenged the assumptions of that to protect consumers it was sufficient if manufacturer's warnings went only to prescribing physicians. In 1970, FDA issued a rule requiring that patient package inserts (PPIs) be dispensed to consumers of OCs. It subsequently revised the regulation in 1978 to require more detailed information about risks of OCs, including hazards discovered since the initial rule. In the earliest OC case, Lukaszewicz v. Ortho Pharmaceutical Corporation, the court based the manufacturer's duty to warn the consumer entirely on FDA's OC rule. Another case to hold that manufacturers must directly warn consumers of the dangers of OCs was Stephens v. G.D. Searle & Company. In MacDonald v. Ortho Pharmaceutical Corporation, the jury returned a special verdict for the plaintiff who had suffered a stroke after taking Ortho-Novum OCs for 3 years, finding that the defendant had not adequately warned the plaintiff although it had adequately warned her physician.
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  12. 12

    CUP: contraceptive users pamphlet.

    Advances in Contraceptive Delivery Systems. 1986 Feb; 2(1):84-103.

    This pamphlet, edited by an ad hoc committee of several consultants, scientists, theologians, public health and family planning directors, and an international attorney, covers the following topics: contra-conception; choices of contraceptives; contraceptive package information; copper IUDs; pelvic inflammatory disease (PID); sexually transmitted diseases; and acquired immunodeficiency syndrome. It includes a questionnaire for sexually transmitted diseases (STDs). Professor Joseph Goldzieher describes the "Contra-Conception" database as "a synthesis of up-to-date literature and contemporary guidelines, designed to provide ready access for practicing physicians and medical students." It contains data on several types of hormonal contraception. "Contra-Conceptions" is designed to allow the physician to set his or her own pace when working with the computer, and no previous computer experience is required. 1 of the program's many innovative features is the patient-profiling/decisionmaking section which can be used in the doctor's office to help decide what type of hormonal contraceptive is appropriate for a particular patient. The program permits the doctor to evaluate the significance of patient variables such as parity, smoking, menstrual difficulties and helps the doctor to identify the risks and benefits of the various methods and, ultimately, to make a balanced decision in the context of the most recent data. Contraceptive drugs and devices should include detailed information on the following: description of formula or device; indication, usage, and contraindications, clinical pharmacology and toxicology; dose-related risk; pregnancies per 100 women year; and detailed warning. The sequence of major pathophysiological reactions associated with copper IUDs is identified as are special problems of pelvic infections in users of copper IUDs. Those women who use oral contraceptives (OCs) or a barrier method of contraception or whose partners use a condom have a lower frequency of PID than women not employing any protection. It is well established that copper IUDs cause different types and different degrees of PID. Women using copper IUDs are more at risk for pelvic infection. There is a higher frequency of salpingitis and PID when copper IUDs are employed especially when the population is nulligravidas under the age of 25. The pamphlet lists criteria for the diagnosis of salpingo-oophoritis and actue salpingitis.
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  13. 13

    Despite court ruling, experts insist spermicides are safe.

    Contraceptive Technology Update. 1985 Mar; 6(3):37-9.

    Recently in Atlanta, Georgia, a US District Judge, Marvin Shoob, ordered Ortho Pharmaceutical Corporation to pay US$5.1 million in damages to a 3 year old girl, born with birth defects to a women who used a spermicide, manufactured by Ortho, when the child was conceived and for 4 weeks following conception. The child was born with a missing left arm, missing fingers on the right hand, a cleft palate, and impaired hearing. The spermicide, Ortho-Gynol, contains octoxynol, which prevents pregnancy by destroying the outer layer of sperm cells. The judge maintained that Ortho was negligent for failing to attach a label to the spermicide warning users that birth defects could occur if the product was used during pregnancy. In 1983, a Food and Drug Administration (FDA) advisory committee advised drug companies that is was unnecessary to attach such a label. The chairman of the committee, Ronald W. Nelson, still maintains that a warning label is unwarrented. "Contraceptive Technology Update" spoke with a number of family planning practitioners and several experts, including some who were involved in the case, concerning their views about the case. Most of the partitioners expressed surprise about the ruling, indicated that they did not plan to alter their counseling advise concerning spermicides, and believed that a warning label was not warranted. A representative for Ortho stated that the company still believes that there is no link between birth defects and the use of spermicides. Ortho does not plan to use a warning label. A spokesman from the judge's office said that the ruling pertained only to the specific case, and that the decision was not generalizable. Robert L. Brent, an expert witness for Ortho said that studies failed to find a significant association between birth defects and spermicides; however, he noted that researchers did not rule out the possibility that there was a slightly increased risk of birth defects among infants born to women who used spermicides. Bruce Buehler, an expert witness for the plaintiff, said that there was a probable link between the spermicide and the missing arm defect and a possible link between the spermicide and the missing fingers. He said that the damage probably occurred at some crucial developmental stage during the 4 weeks following conception rather than at the time of conception. A proponent for labeling is Herschel Jick. He and his colleagues conducted a study in 1981 of 763 women, who had prescriptions for spermicides filled within 600 days of pregnancy outcome, and of 3902 nonusers. 2.2% of the users, compared to 1.1% of the nonusers gave birth to infants with birth defects. The study has been criticized by experts for failing to isolate a well-defined syndrome among infants born to spermicide users and for failing to determine if and when those identified as users actually did use the prescribed spermicides. Jose Cordero of the Center for Disease Control noted that the Center does not have an official position concerning the issue, but that he did not feel that the evidence was strong enough to support claims of an association.
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  14. 14

    General discussion [of factors affecting acceptance and compliance in use of oral contraception].

    Singapore Journal of Obstetrics and Gynaecology. 1984 Mar; 15(1 Suppl):119-23.

    The relative importance of several aspects of oral contraception, i.e., acceptance and compliance, are reviewed. Focuses on reliability, presentation and formulation, cycle control, safety, reversibility, and subjective side effects. Although oral contraceptive (OC) failure may not be such an important event for the population as a whole, it is for the woman who relied on the pills' contraceptive effect. A pill failure in 1 woman may deter many others, who may either stop using OCs or never begin. Data on pill reliability are almost entirely from studies in wrestern nations, and hard data on reliability in the Asian cultural setting may be helpful. The 1st OCs came as 20 tablets in a bottle. Since then different kinds of packaging have been developed, e.g., wheels, bubble strips, differently colored pills for different days. If funds are scarce, however, price-increasing extras will hold little attraction; in such circumstances just 21 tablets in a blister pack will be sufficient. Some types of OCs ensure better cycle control than other. A woman using an OC that does not ensure good cycle control will, at best, ask to be changed to another brand, or she simply will stop taking the pill. The reduced menstrual flow in OC users, which is often claimed in the literature to be an advantage that women appreciate, is often a cause of concern or even discontinuation in Korea. Spotting can be distressing, particularly for Muslim women, but as mutis have now ruled that a woman can still pray when spotting, the negative effect of occasional spotting on motivation will most likely diminish. Doctors may have a good idea of the relative metabolic safety of OC, but field workers, paramedics, and the less well-trained assistants will have a more limited insight. The field workers' influence is a crucial factor. Few of the field workers whose supply OCs and disseminate knowledge actually use OCs themselves. Thus their message will not be very convincing. In the western countries large numbers of teenage girls have been using OCs for some time with no subsequent impairment of fertility. Subjective side effects, such as nausea, may be trivial, but they often discourage women from starting to use OCs or from continuing after the first few months. Subjective side effects are less marked than those experienced with the pills on 15 years ago.
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  15. 15

    The oral contraceptive PPI: its effect on patient knowledge, feelings, and behavior.

    Sands CD; Robinson JD; Orlando JB

    Drug Intelligence and Clinical Pharmacy. 1984 Sep; 18(9):730-5.

    The distribution of the patient package insert (PPI) by pharmacists is at best controversial. Although most health professionals agree that the patient has the right to receive information about drugs, they disagree on the best way to provide that information. Since the oral contraceptive (OC) PPI has been in routine use for approximately 10 years, a large data base exists that can be used to determine not only patient acceptance of the PPI, but also knowledge, feelings, and behavior secondary to the PPI. In this study, 50 women of childbearing age completed a questionnaire, and it was learned that 84% had taken or were currently taking OCs, and 90% of those received a PPI; however, only 61% of these women read all of it. The women performed poorly on the knowledge exam (mean +or- SD, 44.5 +or- 21.2, range 0-83%); those who read all of the PPI or who were white had higher scores (P0.02 and P0.001). 38% of the women thought that the PPI information was inadeqaute, suggesting that it needs to be rewritten and/or supplemented with information from pharmacists. After reading the PPI, 12% contacted their pharmacist for additional information. Pharmacists are in a unique position to provide OC information that enables women to make informed judgments regarding benefit: risk ratios on a personal basis. (author's)
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  16. 16

    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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  17. 17
    Peer Reviewed

    The role of epidemiology in the regulation of oral contraceptives.

    Sobel S

    Public Health Reports. 1984 Jul-Aug; 99(4):350-4.

    The US Food and Drug Administration (FDA) has relied to a great degree on epidemiologic studies in the regulation of oral contraceptives (OCs). These epidemiologic studies range from individual case reports of adverse reactions to case control studies and cohort studies. Important findings about adverse reactions to OCs have been communicated through labeling, which includes information leaflets provided as package inserts for physicians and patients. Also, the FDA communicates its position through publications in medical journals, the FDA Drug Bulletin, public advisory committee meetings, workshops, and symposia. The agency responds to new epidemiologic information. Labeling guidelines are under continuing review and revision. Patterns of OC use have been affected by the dissemination of this information. There has been adecline in the use of OCs, a shift to formulations with lower steroid content, and a greater emphasis on OC use inoptimal groups, such as young, nonsmoking women. Considered for future epidemiologic studies that may have an impact on regulatory action are a clarification of the role of various progestins in regard to blood lipid alteration and atherogenesis, a delineation of the possible persistence of cardiovascular risk after termination of OC use, and further claraification with regard to neoplasia, particularly breast and cervical carcinoma. (author's modified)
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  18. 18

    All contraceptives have problems: toxic-shock syndrome and the vaginal contraceptive sponge.

    Faich GA; Sobel S; Bilstad J

    North Carolina Medical Journal. 1984 Mar; 45(3):197-8.

    In lat 1984, 4 reported cases of toxic shock syndrome (TSS) meeting Centers for Disease Control (CDC) criteria occurred among users of the vaginal contraceptive sponge (Today). All patients manifested fever, hypotension, diffuse rash, desquamation, nausea, vomiting, myalgias, mucous membrane hyperemia, and vaginal discharge. All were hospitalized and treated with intravenous fluids and antimicrobial agents, and all recovered. Vaginal cultures in every case were positive for Staphylococcus aureus. The Today Vaginal Contraceptive Sponge, introduced to the over the counter market in June 1983, is made of polyurethane impregrated with the spermicide nonoxynol-9 and is intended to provide 24 hours of contraception. During clinical trails, the average woman using only this contraceptive method used 10 sponges per month. At the time the sponge was licensed, the US Food and Drug Administration (FDA) required that the package insert contain a warning that clinical trials had not been large enough to assess the risk of TSS and that users should seek medical care if symtoms compatible with TSS developed. Instructions for sponge use indicate that it should not be left in place for more than 30 hours. Following a meeting with FDA representatives on December 16, the manufacturer highlighted the warning on the package insert and placed a similar warning on the outer box. Women who use contraceptive sponges should read the package insert carefully and follow the manufacturer's directions. Users who experience difficulty removing a sponge and/or fragmentation should consult a physician. Women who have had TSS, particularly if it was associated with the use of a contraceptive sponge or tampon, should also consult a physician before beginning or resuming use of either. Postpartum women, who may be at an increased risk of developing TSS, should seek medical advice before using the contraceptive sponge. This report of 4 TSS cases among women using the contraceptive sponge is presented to inform physicians that a potential problem may exist and to encourage the reporting of additional cases. If one assumes that the 4 cases reported thus far were all attributable to contraceptive sponges, a minimum estimate of the incidence of nonmenstrual TSS associated with sponge use would be 10 cases/year/100,000 women who use contraceptive sponges as their only contraceptive method.
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  19. 19

    IUDs: an appropriate contraceptive for many women. DIU: un anticonceptivo apropiado para muchas mujeres.

    Liskin L; Fox G

    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.
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  20. 20

    Maker of contraceptive sponge responds to toxic shock reports.

    Medical World News. 1984 Mar 12; 25(5):26, 31.

    4 confirmed cases of toxic shock syndrome (TSS) associated with use of the Today vaginal contraceptives were reported in the Centers for Disease Control's (CDC) "Morbidity and Mortality Weekly Report." The 4 women involved in the cases, occurring between October 16 and December 10, 1983, were hospitalized but responded to intravenous fluids and antimicrobials and recovered. Gail Bolan, CDC medical epidemiologist, reports that her agency has received no reports of confirmed cases of TSS associated with the sponge's use since December. CDC officials await follow-up information on several suspected cases. Bolan emphasizes that the published report is not intended to imply that a risk of TSS has been established for sponge users. The numbers are too small to make an accurate estimate of any risk of toxic shock for women using the sponge. The point of the article is to make people aware of these developments and to encourage reporting of additional cases so risk can be determined. In giving VLI Corporation of Irvine, California approval to market the contraceptive, US Food and Drug Administraion (FDA) officials noted that clinical trials were not sufficiently large to assess the risk of TSS. Laboratory tests indicate the sponge does not support growth of Staphylococcus aureus, the suspected etiologic culprit in TSS. The 4 confirmed cases prompted a meeting between FDA officials and representatives of VDL. After the meeting, company officials voluntarily agreed to highlight TSS warnings already included on the package insert and to alert users to TSS by adding the warnings to the outside of the package, according to company representative Debra Gaynor. The insert warnings urge users to seek medical attention immediately if they have 2 or more symptoms of TSS; to remove the sponge within the specified time (24-30 hours) and call the company on a toll free line or seek a physician's assistance if difficulty arises when removing the device; and to consult a physician or clinic before using the product after childbirth, miscarriage, or other pregnancy termination. VLI acknowledges receiving more than 100 reports of difficulty in removing the contraceptive. As a result, the company has revised the package to include more specific information. Dr. Armand Lione, president of Associated Pharmacologists and Toxicologists, and an early critic of the sponge has adopted a wait and see attitude toward the TSS developments. The Washington based research group petitioned the FDA last summer to reassess its approval of the contraceptive, contending the device was not adequately tested to determine the risk of exposure to dioxane. FDA officials are delaying a response to the petition for reassessment until they have made a final review of the TSS information.
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  21. 21

    Questions and answers of the Fertility and Maternal Health Drugs Advisory Committee.

    Gregoire AT; Sobel S; Weiner A; Bennett R; Bilstad J; McCann D; Carter L; Price P; Lamar J; Millstein L

    [Unpublished] 1984 Feb. 4 p.

    A recent publication in "Lancet" by Pike et al. concluded that women who used oral contraceptives (OCs) for extended periods of time before age 25 were at an increased risk for the development of breast carcinoma. The authors also suggested that OCs with high progestational activity, as determined by a delay of menses test, accounted for this elevated risk. Other studies have addressed the issue of the relationship of OCs and breast carcinoma and the findings have been presented to the Fertility and Maternal Health Drugs Advisory Committee. The Committee, after a careful review of the paper by Pike et al. and a number of other recent studies relevant to OC use and breast cancer, concludes that a significant increase in risk for development of breast cancer has not been demonstrated in any subgroup of OC users or with any particular OC. The Agency is increasingly concerned about several studies which have shown an increased incidence of cervical carcinoma in patients using OCs. Probably a major problem in interpreting the results of these studies is the inability to eliminate with certainty the possible confounding effects of sexual activity. The Committee believes the changes suggested in the labeling reviewed 2 years ago under the heading "carcinoma" will answer the question regarding cervical cancer and no other changes need to be considered. The Agency has favored the use of OCs with lower steroidal content. In regard to the estrogen component, a clear recommendation has been made for the use of the low estrogenic dose. At this time there is no specific recommendation in regard to progestin content. This is due in part to an uncertainty of the ranking of progestational potencies of the various progestins. There is a less clear association of progestin with cardiovascular events. Recently, there is increased concern about the possible contribution of the progestin content to cardiovascular morbidity and mortality. This contribution may be mediated by effects on blood pressure, lipids, and perhaps blood clotting. The statement in the proposed changes in the current labeling under "Dose related risk of vascular disease from oral contraceptives" is believed to answer the question regarding risk and labeling. There are possible additional risks that may be associated with the inclusion of progestational agents in the estrogen replacement regimen. The potential risks include adverse effects on carbohydrate and lipid metabolism and possibly on coagulation factors. The Committee does not feel that labeling for progestin in estrogen replacement therapy is necessary at this time because of uncertainty about their safety.
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  22. 22

    Advisory committee finds breast cancer-OC link unconvincing.

    Cruzan SM

    Rockville, Maryland, Food and Drug Administration, 1984 Feb 13. 2 p. (FDA Talk Paper T84-15)

    FDA's Fertility and Maternal Health Drugs Advisory Committee met February 9 and 10 to review data concerning the possible relationship of oral contraceptives (OCs) and breast and cervical cancer. Dr. Malcolm Pike, senior author of a study recently published in the Lancet presented his views before the committee. His study linked an increased risk of breast cancer with the use of "high progestogen" OCs for an extended period before the age of 25. The committee said, "After careful review of the paper by Pike et al., plus a number of other studies relevant to OC use and breast cancer, the committee concludes that a significant increase in the risk or development of breast cancer has not been demonstrated for any subgroup of OC users." The committee referred to a larger study by the Centers for Disease Control, which presented a reanalysis of its data, as well as smaller studies that have not shown a significant association between the use of OCs and breast cancer. Nevertheless, the committee recommended that the labeling for OCs should advise annual breast exams along with annual Pap tests. Another paper published in the same issue of the Lancet reported an increased risk of cervical cancer. The committee said it is difficult to interpret the study because the history of sexual experience in the study subjects is not known. The committee stated that labeling revisions which have been suggested previously by the advisory committee and which are now under review by FDA address that risk. The revised labeling states that OC use may be associated with an increase in the risk of developing intraepithelial cervical neoplasia (a precancerous condition) but differences in sexual exposure between users and the nonuser may account for the difference in risk. The committee also addressed the issue of the progestin content of OCs because of the possible adverse effects of this component on the cardiovascular system. The committee again referred to labeling revisions already under review which recommend that doctors prescribe OCs with the least amount of progestin along with the least amount of estrogen compatible with the needs of patients. FDA will review the committee's recommendations before deciding what action it will take. (full text)
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  23. 23

    [Adverse drug reactions (editorial)] Ongewenste reaksies deur medikasie veroorsaak.

    South African Medical Journal. 1981 Sep 5; 60(10):373.

    A law in the US states that anyone who sells a defective or hazardous product is responsible for the damage caused by this product. 2 parts particularly relevant to prescription drugs are: 1) if the product contains elements to which a large part of the population is allergic it must contain a warning as well as instructions on usage, and 2) if drugs are hazardous, even in normal dosage and usage, and cannot be made safe, they must contain the necessary warning. This is not the end of it. A case in point is diethylstilbestrol (DES), freely manufactured since 1952 but by 1971 statistically related to the occurrence of vaginal and cervical cancer in young women whose mothers used DES during pregnancy. Lawsuits in DES cases go as far as claiming against all drug companies which manufactured DES since, in many cases, the original manufacturer was not known. This is a severe setback for the drug industry; it will cause prices to increase, competition to lessen and it threatens the end of unpatented drugs (the end of generic prescriptions).
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  24. 24
    Peer Reviewed

    The tetracycline--oral contraceptive controversy.

    Hudson CP; Callen JP

    Journal of the American Academy of Dermatology. 1982 Aug; 7(2):269-70.

    The package labeling of oral contraceptives (OCs) specifically lists tetracycline as one of the antibiotics which, taken concomitantly with OCs, may decrease the effectiveness of the drugs and increase the incidence of breakthrough bleeding. Since tetracycline is often prescribed to patients with acne caused by OCs, this statement is of concern to dermatologists. Research regarding the interaction of OCs and tetracycline is scarce, but there are single case reports of breakthrough bleeding or of pregnancy during the concomitant use of OCs and tetracycline. The only study directly addressing the problem of the interaction between the 2 drugs concluded that tetracycline may influence estrogen metabolism in some patients. Further study is necessary to determine the influence of tetracycline on OC use; in the meantime patients should be informed of the possibility of breakthrough bleeding or of pregnancy. When topical therapy, including topical antibiotics, cannot control acne, and when systemic antibiotic therapy is indicated, the use of an alternate form of contraception could be considered.
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  25. 25

    Official transcript of proceedings; Food and Drug Administration. Depo-Provera Public Board of Inquiry. Vol. 1, January 10, 1983.

    United States. Food and Drug Administration [FDA]. Depo-Provera Public Board of Inquiry

    Arlington, Virginia, TIW Reporting Group, [1983]. 205 p.

    The objective of the Depo-Provera Public Board of Inquiry is to determine how the conclusion reached on the basis of data and facts presented can be interpreted in light of that evidence. Both "pro and con views" are questioned. These proceedings include the opening remarks of Doctor Judith Weisz and presentations and comments from the following physicians: Jacob C Stucki; Gordon W. Duncan; Roy Hertz; Marion Valerio; Ron H. Gray; Saul Ginsberg; George L. Wied; J.C. Stryker; Elizabeth B. Connell; Daniel R. Misbell Jr.; Robert Carlson; and Dr. Assenzo. In his testimony Dr. Stucki, Vice President of Pharmaceutical Research, Upjohn, presented slides demonstrating a chronology of research regulatory events concerning Depo-Provera. Stucki reported that 25 years of research has generated an enormous body of literature on Depo-Provera and numerous submissions to the US Food and Drug Administration (FDA). With each challenge to Depo-Provera, the information and any new findings were reexamined. According to Stucki, each reevaluation has added to the evidence of Depo-Provera's safety. Stucki related that the Board of Inquiry addresses 7 questions each focusing in 1 way or another on Depo-Provera's safety as a contraceptive. 2 questions relate to the issue of whether it is reasonable to extrapolate from the animal data to humans in predicting cancer risk, and whether there are sufficient data from human use to make a judgment. Several witnesses discuss the extensive data relating to this issue. According to Stucki, the witnesses share the conviction that there is strong scientific basis for the conclusion that tumors found in some animals are not predictive of a risk of cancer in humans and that evidence from the use of Depo-Provera in thousands of women over a 20-year period support the conclusion that Depo-Provera does not increase the risk of cancer in women. In a 3rd question, the FDA asks if Depo-Provera is likely to cause birth defects if it is inadvertently taken during pregnancy. Stucki relates that witnesses for the Upjohn Company show that there is no evidence that Depo-Provera increases the risk of such defects. Another critical issue is whether the risks of Depo-Provera outweigh its benefits. A question about supplemental estrogen use is addressed by a brief presentation of evidence that this has not been and will not be a problem in clinical use of Depo-Provera. Stucki states that 2 questions appear to go beyond the scope of scientific inquiry: whether Depo-Provera under general marketing conditions is likely to increase out of label use; and whether labeling and distribution controls should be imposed to permit only limited marketing.
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