Diethylstilbestrol (DES): Hearing Before the Subcommittee on Health and the Environment of the Committee on Interstate and Foreign Commerce, House of Representatives, Ninety-fourth Congress, First Session, on Title I of S. 963 ... December 16, 1975U.S. Government Printing Office, 1976 - 78 էջ |
From inside the book
Արդյունքներ 24–ի 1-ից 5-ը:
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... Additional material submitted for the record by- Cowan , Belita , instructor in health care , University of Michigan , sur- vey of 65 women who took the morning after pill , 1968-74- Health , Education , and Welfare Department ...
... Additional material submitted for the record by- Cowan , Belita , instructor in health care , University of Michigan , sur- vey of 65 women who took the morning after pill , 1968-74- Health , Education , and Welfare Department ...
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... additional data on clinical safety and effectiveness are necessary and only questions related to manufacturing and bioavailability exist . The conditions for marketing DES as an emergency postcoital con- traceptive set forth in the ...
... additional data on clinical safety and effectiveness are necessary and only questions related to manufacturing and bioavailability exist . The conditions for marketing DES as an emergency postcoital con- traceptive set forth in the ...
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... additional requirement that the label on all DES products , whether or not the drug was intended for use in postcoital contraception , state that , " This drug may not be used as a contraceptive after sexual intercourse except in cases ...
... additional requirement that the label on all DES products , whether or not the drug was intended for use in postcoital contraception , state that , " This drug may not be used as a contraceptive after sexual intercourse except in cases ...
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... addition to the consent form , a copy of every prescription filled for DES ( again for any use ) in the United States . The system would not , however , contribute to FDA's ability to monitor postcoital use of DES because S. 963 fails ...
... addition to the consent form , a copy of every prescription filled for DES ( again for any use ) in the United States . The system would not , however , contribute to FDA's ability to monitor postcoital use of DES because S. 963 fails ...
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... additional characteristics which are of particular interest today . It prevents pregnancy if administered shortly after intercourse , even if the woman is at her most fertile period mid- way in the menstrual cycle . DES is also known to ...
... additional characteristics which are of particular interest today . It prevents pregnancy if administered shortly after intercourse , even if the woman is at her most fertile period mid- way in the menstrual cycle . DES is also known to ...
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Common terms and phrases
abortion action adenocarcinoma adverse animals approved beef breast carcinogenic carcinoma CARTER cattle cause cancer cervix Chairman clear-cell adenocarcinoma clinical colposcopic Commissioner concludes Congress contraindicated daughters developing cancer diethylstilbestrol disease doctor dosage forms Drug Administration drug application Drug Bulletin endometrial endometrial carcinoma estrogens evidence exposed exposure FDA's Federal Food FEDERAL REGISTER feed female fetus Food and Drug Gynecology Advisory Committee hazards Herbst hormone informed consent LEIBOWITZ menopausal MERRILL mice morning-after pill mothers Obstetrics and Gynecology offspring oral contraceptives paragraph patient labeling patient leaflet patient package insert pelvic percent physician postcoital contraceptive pregnancy prescribed prescription present preventing pregnancy PREYER problem proposed rape victims regulation reported risk of developing ROGERS safe safety and effectiveness SCHMIDT scientific Secretary side effects statement stilbestrol studies subcommittee tablets Thank therapy tion tive traceptive treatment tumors users uterine utero vaginal adenosis vaginal cancer warning WENTZ
Սիրված հատվածներ
Էջ 29 - A warning regarding the serious side effects with special attention to thromboembolic disorders and stating the estimated morbidity and mortality In users vs. nonusers. Other serious side effects to be mentioned include mental depression, edema, rash, and jaundice. The possibility of infertility following discontinuation of the drug should be mentioned.
Էջ 3 - Be it enacted by the Senate and House of Representa tives of the United States of America in Congress assembled, That this Act may be cited as the "Clean Lakes Act of 4 1971".
Էջ 26 - DES carries a significant carcinogenic risk either to the mother or fetus. However, because existing data support the possibility of delayed appearance of carcinoma in females whose mothers have been given DES later in pregnancy, and because teratogenic and other adverse effects on the fetus with the very early administration recommended are ill understood, failure of postcoital treatment with DES deserves serious consideration of voluntary termination of pregnancy. Before prescribing, the physician...
Էջ 29 - A statement regarding production of cancer in certain animals. This may be coupled with a statement that there is no proof of such effect in human beings.
Էջ 25 - ... physicians and patients that drugs are safe and effective for their intended uses. The full disclosure of information to physicians concerning such things as the effectiveness, contraindications, warnings, precautions and adverse reactions is an important element in the discharge of this responsibility. In view of this, the Administration has reviewed the oral contraceptive products, taking into account the following factors: The products contain potent steroid...
Էջ 25 - ... that the most important complication is abnormal blood clotting which can have a fatal outcome, that the physician recognizes an obligation to discuss the potential hazards of taking the drugs with the patient, that he has available for the patient written material discussing the effectiveness and the hazards of the drugs, and that users of the oral contraceptives should notify their physicians if they notice any unusual physical disturbance or discomfort.
Էջ 24 - You should use this drug only under the direction of your physician. This treatment is for emergencies only and should not be used repeatedly. If you find it necessary to use this treatment more than once, you should consult with your physician to obtain an adequate method of routine contraception. This treatment is usually effective in preventing pregnancy if used as described above. However, this drug will not cause an abortion if you are already pregnant. Before prescribing this drug, your physician...
Էջ 26 - The effectiveness of diethylstilbestrol in preventing pregnancy depends upon the time lapse after coitus and administration of the drug. The recommended dosage is one 25 milligram tablet twice a day, for 5 consecutive days beginning, preferably, within 24 hours and not later than 72 hours after exposure. When this dosage is given within the specified time interval, the drug is usually effective in preventing conception.
Էջ 30 - preferably in quintuplicate) regarding this proposal. Comments may be accompanied by a memorandum or brief in support thereof.
Էջ 29 - The oral contraceptives are restricted to prescription sale, and their labeling is required to bear information under which practitioners licensed to administer the drugs can use them safely and for the purpose for which they are intended. In addition, in the case of oral contraceptive drugs, the Commissioner...