COMMENTARY

December 2004: The Year in Review -- Ob/Gyn & Women's Health

Ursula Snyder, PhD

Disclosures

January 24, 2005

Gynecology - Hormonal Contraception

Very briefly, here are some of the findings relating to hormonal contraception that made the professional health news in 2004.

There is a miniscule or no association between use of low-dose oral contraceptives (OCs) and increased risk of stroke.[25] Moreover, OCs may reduce the risk of cardiovascular disease, according to an analysis of data from the Women's Health Initiative. (See Medscape Medical News story.) Use of OCs seems to lower the risk of developing rheumatoid arthritis[26] but may lead to kidney damage in women with type 1 diabetes (see Medscape Medical News story.) OCs had generally beneficial effects on body composition in female athletes without adverse effects on physical performance and may be useful for prevention of osteoporosis in athletic amenorrhea.[27] (See Medscape Medical News CME story.) Pregravid oral contraceptive use seems to increase fetal birth weight and placental weight.[28]

Depot medroxyprogesterone acetate (DMPA) use is associated with loss of bone mineral density (BMD) during the first 2 years of use.[29] Hip and spine BMD decreased after a single DMPA injection and continued to so with each subsequent injection for 24 months. The authors note that "with the exception of increasing BMI among DMPA users, no user characteristics offered protection against DMPA-related BMD loss." (See Medscape Medical News CME story.)

A new study on levonorgestrel as emergency contraception showed that it was well tolerated and had only minor side effects in teenagers 13 to 16 years of age.[30] And, in a randomized trial, a small dose of mifepristone (10 mg) was comparable to levonorgestrel (2 doses of 750 micrograms given 12 hours apart) in the context of emergency contraception within 120 hours of unprotected intercourse; both regimens were highly acceptable to women.[31] (See Medscape Medical News CME story.) In addition, a study investigating both levonorgestrel and mifepristone as emergency contraceptives showed that when these are administered before ovulation, they act through an impaired ovulatory process and luteal function.[32] However, an alert on mifepristone was issued in 2004 in relation to its use in pregnancy termination (see Medscape Medical News story), and a subsequent editorial in the New York Times questioned the safety of mifepristone for early medical abortion and called for withdrawal of the drug from the market.[33] The American College of Obstetrics and Gynecology (ACOG) responded adamantly with a letter to the editor. An excerpt bears reprinting here:

"Far from being inherently dangerous, RU-486 has an impressive safety record in the US -- just as it does across the globe. An estimated 360,000 US women have used RU-486. Three women who received it have died (although a causal link to RU-486 is not yet clear in all three cases). Nevertheless, the fatality rate for RU-486 -- less than 1 death (0.8) per 100,000 procedures -- is still extremely low. For perspective: it's less than the fatality rate from a shot of penicillin (2 deaths per 100,000 cases) and nearly identical to women's low death rate from common miscarriage. It's far less than the fatality rate for childbirth (about 12 maternal deaths per 100,000 births), and its risks are lower than those for dental procedures and hernia operations.

Do these facts diminish the tragedy of even one death from an FDA-approved drug? No. Vigorous, reasonable efforts to make RU-486 even safer for US women are welcome. The FDA's new labeling information is an important supplement to the product's already-comprehensive precautions and patient counseling requirements.

But to say that the safety record of RU-486 merits its withdrawal as a choice for US women is absolutely unwarranted. Imposing politics into the fact-finding process of the FDA is the real "dangerous" medicine."

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