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 14–ի 1-ից 5-ը:
Էջ 47
... examinations and evalua- tions to establish the safety or hazards of a drug prior to the drug's release or approval by the FDA . Because there has been no long - term followup on the 30 to 40 million women given diethylstilbestrol to ...
... examinations and evalua- tions to establish the safety or hazards of a drug prior to the drug's release or approval by the FDA . Because there has been no long - term followup on the 30 to 40 million women given diethylstilbestrol to ...
Էջ 50
... examination by their doctor . Fifty - six percent stated that the doctor did not take a personal and family medical history . Only 26 percent were followed up to see if the DES worked . Twenty- five percent didn't take all 10 pills ...
... examination by their doctor . Fifty - six percent stated that the doctor did not take a personal and family medical history . Only 26 percent were followed up to see if the DES worked . Twenty- five percent didn't take all 10 pills ...
Էջ 53
... examination , most of the affected women do not know of their at - risk status . It is important to remember that FDA and AMA offi- cials have considered it inadvisable to attempt large - scale identification of this population . I am ...
... examination , most of the affected women do not know of their at - risk status . It is important to remember that FDA and AMA offi- cials have considered it inadvisable to attempt large - scale identification of this population . I am ...
Էջ 55
... examination , iodine staining , or other methods . I am what we call a DES daughter , that is my mother took the ... examinations . I am very lucky . My mother knew what drugs she took when she was pregnant . Also , I earn enough money ...
... examination , iodine staining , or other methods . I am what we call a DES daughter , that is my mother took the ... examinations . I am very lucky . My mother knew what drugs she took when she was pregnant . Also , I earn enough money ...
Էջ 57
... examinations are not carried out . We urge you to support expansion of and development of other procedures in order to keep options open and to increase those options for women in need of postcoital birth control . We know that for the ...
... examinations are not carried out . We urge you to support expansion of and development of other procedures in order to keep options open and to increase those options for women in need of postcoital birth control . We know that for the ...
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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...