ENDNOTES

1.  

Institute of Medicine. Contraceptive Research and Development: Looking to the Future. PF Harrison, A Rosenfield, eds. Washington, D.C.: National Academy Press, 1996. The study was supported by the Rockefeller Foundation, the Andrew W. Mellon Foundation, the National Institute of Child Health and Human Development, the Contraceptive Research and Development (CONRAD) Program, and the United States Agency for International Development.

2.  

The workshop and this report are supported by a grant from the Henry J. Kaiser Family Foundation.

3.  

Medical officer NDA review. NDA#19-897. Rockville, MD: Food and Drug Administration, 1990.—Grubb GS, D Moore, NG Anderson, et al. Pre-introductory clinical trials of Norplant® implants: A comparison of 17 countries' experience. Contraception 52:287-296, 1995.— Sivin I. Contraception with NORPLANT® implants. Human Reproduction 9:1818-1826, 1994.

4.  

Patient labeling for Norplant is organized by risks, warning signals, precautions, and side effects. Provider prescribing information is organized by contraindications, warnings, precautions, and adverse reactions. For Norplant, the FDA sorted the last group into four subcategories: (a) conditions associated with Norplant during the first year of use; (b) conditions that occurred more frequently among Norplant users than among a control group of IUD users, with differences in incidence great enough to attain statistical significance as being probably related to Norplant use; (c) conditions occurring with a frequency of 5 percent or more during the first year of use in clinical trials and judged to have possibly been associated with its use; and (d) conditions observed in Norplant users postmarketing but for which there is no basis for judging a causal relationship (Food and Drug Administration. Norplant® Implants Revised Labeling: Information for Providers [Draft], March 1995).

5.  

Affandi B, SSI Santoso, Djajadilaga, W Hadisaputra, FA Moeloek, .I Prihartono, F Lubis, and RS Samil. Five-year experience with NORPLANT. Contraception 36:417-428, 1987.

Akhter H, TR Dunson, RN Amatya, K Begum, T Chowdhury, N Dighe, SL Krueger, and S Rahman. A five-year clinical evaluation of NORPLANT contraceptive subdermal implants in Bangladesh acceptors. Contraception 47:569-582, 1993.

Brache V, F Alvarez-Sanchez, A Faundes, AS Tejeda, and I, Cochon. Free levonorgestrel index and its relationship to luteal activity during long-term use of NORPLANT implants. Advances in Contraception 8:319-326, 1992.

Chompootaweep S, E Kochagarn, S Sirisumpan, J Tang-ushu, B Teppitaksak, and N Dusitin. Effectiveness of NORPLANT implants among Thai women in Bangkok. Contraception 53:33-36, 1996.

Crosby UD, BE Schwarz, KL Gluck, and SF Heartwell. A preliminary report of NORPLANT implant insertions in a large urban family planning program. Contraception 48:359-366, 1993.

Cullins VE, PD Blumenthal, RE Remsburg, and GR Huggins. Preliminary experience with NORPLANT in an inner-city population. Contraception 47:193-204, 1993.

Cullins VE, RE Remsburg, PD Blumenthal, et al. Comparison of adolescent and adult experiences with Norplant levonorgestrel contraceptive implants. Obstetrics and Gynecology 83:1026-1032, 1994.



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