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R A Hatcher

Publications and source records attributed to R A Hatcher.

At least 37 records · Page 2Linked to original sources

The Food and Drug Administration and medroxyprogesterone acetate. What are the issues?

In 1978, the Food and Drug Administration denied approval of the three-month injectable contraceptive depot medroxyprogesterone acetate for use in the United States. This decision goes against the advice of the FDA's own scientific advisory panels, as well as the rulings of the World Health Organization and the drug regulation institutions of more than 70 developed and developing countries. In response to protest from the manufacturer of depot medroxyprogesterone acetate and from many health professionals, the FDA took the unusual step of scheduling a public board of inquiry to review its decision in January 1983. Reviewing the scientific literature on the risks and benefits of depot medroxyprogesterone acetate, we find no reason to deny depot medroxyprogesterone acetate approval, provided that studies of its possible side effects are continued and that women use it only after having made an informed choice between this and other methods of contraception.

Delayed-Action Preparations↗

Risk of breast, uterine corpus, and ovarian cancer in women receiving medroxyprogesterone injections.

Animal studies have yielded conflicting results on the carcinogenicity of long-acting progestins. Since more than 1.5 million women worldwide are currently receiving injections of a contraceptive progestin, depot medroxyprogesterone acetate, this is potentially an important public health problem. We obtained information on the occurrence of breast, uterine, and ovarian cancer among 5,000 black women attending a metropolitan hospital's family planning clinic who had received injections of medroxyprogesterone for contraception (between 1967 and 1976). The women were followed up for four to 13 years after their initial medroxyprogesterone injection. We compared the observed number of cancer cases in these women with the expected number based on annual age-, race-, and sex-specific rates derived from National Cancer Institute data. During more than 40,000 woman-years of observation, we found no evidence of an increased risk of developing cancer of the breast, uterine corpus, or ovary in these women. After adjusting for possible underascertainment of cancer because of incomplete follow-up, we found the relative risk for medroxyprogesterone users to be 0.7 for breast cancer (95% confidence limits, 0.3 to 1.4), 1.2 (95% confidence limits, 0.1 to 6.7) for cancer of the uterine corpus, and 0.8 (95% confidence limits, 0.1 to 4.6) for ovarian cancer.

Adolescent↗

Rh immunoglobulin use with placenta previa and abruptio placentae.

Patients with obstetric hemorrhage from placenta previa or abruptio placentae may be at increased risk of Rh sensitization because they fail to receive Rh immunoglobulin (RhIG) or are given an inadequate dose. To evaluate the use of RhIG in this clinical situation, we studied 498 patients with hemorrhage from placenta previa or abruptio placentae treated at a large municipal hospital from 1975 to 1979. All 25 RhIG candidates received the product before their discharge from the hospital. This rate of RhIG use was equal to that for patients whose infants were delivered without these complications and significantly higher than that for patients with spontaneous abortion and ectopic pregnancy at the same hospital (P less than .05). Prompt administration of an adequate dose of RhIG to candidates with bleeding from placenta previa or abruptio placentae can further reduce Rh hemolytic disease.

Abortion, Spontaneous↗

Rh immunoglobulin utilization after ectopic pregnancy.

To assess the use of Rh immunoglobulin (RhIG) after ectopic pregnancy, we reviewed the charts of 305 patients treated from 1975 through 1978 at a large metropolitan hospital. We compared these patients with 389 who had had spontaneous abortions and been treated at the same hospital in 1975. The rate of ascertainment of Rh type was significantly higher for the group with ectopic pregnancy than for the group with spontaneous abortion (98.4% versus 95.1%; p less than 0.05). Nevertheless, presumable fertile RhIG candidates after ectopic pregnancy were 3.3 times more likely not to receive RhIG than candidates after spontaneous abortion (64.3% versus 19.4%;; p less than 0.01). Patients with ectopic pregnancy are an important part of the "RhIG utilization gap"; the mechanism for providing prophylaxis for patients needs to be improved.

Abortion, Spontaneous↗

Blood pressure and oral progestational agents. A prospective study of 119 black women.

Blood pressure and body weight were carefully measured in 119 young black women before and after 6 to 24 months of contraceptive therapy with oral progestational agents (minipills). Results are compared with 673 women followed during continued use of nonhormonal contraceptive methods. Minipill therapy (0.35 mg of norethisterone) was associated with no significant (p greater than 0.05) increase in either systolic or diastolic blood pressure means. Minipill users did not develop diastolic blood pressures of 90 mm Hg or more during the study period. Substantial weight gain occurred as a side effect.

Adolescent↗