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, 1975
United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment
U.S. Government Printing Office, 1976 - 78 էջ
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action additional adenocarcinoma adenosis adverse already American animals application approved association believe bill breast cancer carcinogenic carcinoma CARTER cause changes clinical Commissioner Committee concern concludes Congress consent consider contain continued currently daughters determine develop diethylstilbestrol disease doctor dosage Drug Administration effects emergency estrogens evidence examination exposed exposure fact FEDERAL REGISTER feed female finding Food and Drug given hearings hormone human important increased indication intended issues known labeling method morning-after pill mothers Obstetrics oral contraceptives paragraph patient package insert percent persons physician pill possible postcoital contraceptive pregnancy prescribed prescription present printed problem proposed question rape received record regarding regulation reported risk ROGERS safe safety SCHMIDT scientific Secretary Senate side effects specific statement studies subcommittee tablets taken testing Thank therapy tion treatment vaginal warning women
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 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...