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 33–ի 1-ից 5-ը:
Էջ 1
... prescribed in obstetrical practice for the treat- ment of habitual or threatened miscarriage . In 1971 an association was reported and confirmed between the maternal ingestion of DES during pregnancy and the occurrence of vaginal cancer ...
... prescribed in obstetrical practice for the treat- ment of habitual or threatened miscarriage . In 1971 an association was reported and confirmed between the maternal ingestion of DES during pregnancy and the occurrence of vaginal cancer ...
Էջ 5
... physician's prescription for such drug is sub- mitted by the attending physician to the Secretary at such times and in such form as the Secretary may require but not less than four times a year . Each and every executed informed consent ...
... physician's prescription for such drug is sub- mitted by the attending physician to the Secretary at such times and in such form as the Secretary may require but not less than four times a year . Each and every executed informed consent ...
Էջ 6
... physician to 12 the patient and is thereafter executed by the attending 13 physician and patient or the patient's legal guardian . If the 10 14 15 16 17 18 19 20 21 22 23 23 24 Commission fails to take action within sixty days after the ...
... physician to 12 the patient and is thereafter executed by the attending 13 physician and patient or the patient's legal guardian . If the 10 14 15 16 17 18 19 20 21 22 23 23 24 Commission fails to take action within sixty days after the ...
Էջ 11
... drug , as I will outline shortly . The final order , which became effective on March 8 , 1975 , permits marketing of DES for postcoital contraceptive use by any applicant who obtains approval of an abbreviated new drug application ...
... drug , as I will outline shortly . The final order , which became effective on March 8 , 1975 , permits marketing of DES for postcoital contraceptive use by any applicant who obtains approval of an abbreviated new drug application ...
Էջ 12
... drug . Section 102 would amend the Federal Food , Drug , and Cosmetic Act to make any human drug containing DES misbranded unless its label bears a prescribed warning statement , and unless certain other specified requirements are met ...
... drug . Section 102 would amend the Federal Food , Drug , and Cosmetic Act to make any human drug containing DES misbranded unless its label bears a prescribed warning statement , and unless certain other specified requirements are met ...
Այլ խմբագրություններ - View all
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...